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Sample records for good laboratory practices

  1. Good Laboratory Practice. Part 1. An Introduction

    ERIC Educational Resources Information Center

    Wedlich, Richard C.; Libera, Agata E.; Pires, Amanda; Therrien, Matthew T.

    2013-01-01

    The Good Laboratory Practice (GLP) regulations were put into place in 1978. They establish a standard of practice to ensure that results from the nonclinical laboratory study reported to the U.S. Food and Drug Administration (FDA) are valid and that the study report accurately reflects the conduct of the study. While the GLP regulations promulgate…

  2. Good Laboratory Practice. Part 3. Implementing Good Laboratory Practice in the Analytical Lab

    ERIC Educational Resources Information Center

    Wedlich, Richard C.; Pires, Amanda; Fazzino, Lisa; Fransen, Joseph M.

    2013-01-01

    Laboratories submitting experimental results to the Food and Drug Administration (FDA) or the Environmental Protection Agency (EPA) in support of Good Laboratory Practice (GLP) nonclinical laboratory studies must conduct such work in compliance with the GLP regulations. To consistently meet these requirements, lab managers employ a "divide…

  3. [Good laboratory practice in occupational hygiene].

    PubMed

    Stetkiewicz, Jan

    2004-01-01

    Good laboratory practice (GLP) is the system that ensures quality assessment, defines the organization rules of institutions performing non-clinical studies in the area of human and environmental safety in general, and of chemicals and chemical preparations in particular as well as sets the conditions of planning, performing and monitoring of studies, the outcome of which is recorded, stored and reported. Occupational hygiene is an area of activities that involves anticipation, assessment and surveillance of health hazards in the work environment aimed at protecting health of workers and the population at large (IOHA). Assessment and control of harmful agents, which occur in the work environment, technological processes or methods of work should be carried out by research units (laboratories) with well documented competencies in the environment and/or biological monitoring, and those granted accreditation according to EN/ISO 17025. Anticipated risks should be based on analyses of physical, chemical and toxic properties of harmful agents, performed in line with the rules of good laboratory practice. Accredited laboratories and the quality of their tests are monitored by governmental agencies. The application of the GLP system provides: the opportunity to investigate analytical procedures and data (the documentation concerning each stage of a given analysis should ensure a complete reconstruction of the whole analytical process); the confirmed reliability of the results; the recognition of the results in European Union member states and by the Organization for Economic Cooperation and Development (OECD); the opportunity to avoid repetition of analyses and studies; a better care of the human health and environment. PMID:15156764

  4. 75 FR 80011 - Good Laboratory Practice for Nonclinical Laboratory Studies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-21

    ..., 1978 (43 FR 60013). As stated in its scope (Sec. 58.1), this regulation prescribes good laboratory..., sponsors have requested the ability to cite compliance with the applicable good manufacturing requirements... be required under a revised part 58, subpart F or the relevant good manufacturing requirements....

  5. Good Laboratory Practice. Part 2. Recording and Retaining Raw Data

    ERIC Educational Resources Information Center

    Wedlich, Richard C.; Libera, Agata E.; Pires, Amanda; Tellarini, Cassandra

    2013-01-01

    A clear understanding of how "raw data" is defined, recorded, and retained in the laboratory record is essential to the chemist employed in the laboratory compliant with the Good Laboratory Practices regulations. This article is intended to provide an understanding by drawing upon examples taken from the modern pharmaceutical analysis…

  6. Good Manufacturing Practices (GMP) / Good Laboratory Practices (GLP) Review and Applicability for Chemical Security Enhancements

    SciTech Connect

    Iveson, Steven W.

    2014-11-01

    Global chemical security has been enhanced through the determined use and integration of both voluntary and legislated standards. Many popular standards contain components that specifically detail requirements for the security of materials, facilities and other vital assets. In this document we examine the roll of quality management standards and how they affect the security culture within the institutions that adopt these standards in order to conduct business within the international market place. Good manufacturing practices and good laboratory practices are two of a number of quality management systems that have been adopted as law in many nations. These standards are designed to protect the quality of drugs, medicines, foods and analytical test results in order to provide the world-wide consumer with safe and affective products for consumption. These standards provide no established security protocols and yet manage to increase the security of chemicals, materials, facilities and the supply chain via the effective and complete control over the manufacturing, the global supply chains and testing processes. We discuss the means through which these systems enhance security and how nations can further improve these systems with additional regulations that deal specifically with security in the realm of these management systems. We conclude with a discussion of new technologies that may cause disruption within the industries covered by these standards and how these issues might be addressed in order to maintain or increase the level of security within the industries and nations that have adopted these standards.

  7. 78 FR 53151 - The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-28

    ... guidance answers commonly asked questions about the applicability of good laboratory practice (GLP) to.... SUPPLEMENTARY INFORMATION: I. Background FDA issued the GLP regulations in response to public concerns that... poor research practices and laboratory misconduct. The GLP regulations apply to nonclinical...

  8. Going GLP: Conducting Toxicology Studies in Compliance with Good Laboratory Practices.

    PubMed

    Carroll, Erica Eggers

    2016-01-01

    Good laboratory practice standards are US federal regulations enacted as part of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR Part 160), the Toxic Substance Control Act (40 CFR Part 792), and the Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58) to support protection of public health in the areas of pesticides, chemicals, and drug investigations in response to allegations of inaccurate data acquisition. Essentially, good laboratory practices (GLPs) are a system of management controls for nonclinical research studies involving animals to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of data collected as part of chemical (including pharmaceuticals) tests, from in vitro through acute to chronic toxicity tests. The GLPs were established in the United States in 1978 as a result of the Industrial Bio-Test Laboratory scandal which led to congressional hearings and actions to prevent fraudulent data reporting and collection. Although the establishment of infrastructure for GLPs compliance is labor-intensive and time-consuming, achievement and maintenance of GLP compliance ensures the accuracy of the data collected from each study, which is critical for defending results, advancing science, and protecting human and animal health. This article describes how and why those in the US Army Medical Department responsible for protecting the public health of US Army and other military personnel made the policy decision to have its toxicology laboratory achieve complete compliance with GLP standards, the first such among US Army laboratories. The challenges faced and how they were overcome are detailed. PMID:27613211

  9. Good laboratory practices for biochemical genetic testing and newborn screening for inherited metabolic disorders.

    PubMed

    2012-04-01

    Biochemical genetic testing and newborn screening are essential laboratory services for the screening, detection, diagnosis, and monitoring of inborn errors of metabolism or inherited metabolic disorders. Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, laboratory testing is categorized on the basis of the level of testing complexity as either waived (i.e., from routine regulatory oversight) or nonwaived testing (which includes tests of moderate and high complexity). Laboratories that perform biochemical genetic testing are required by CLIA regulations to meet the general quality systems requirements for nonwaived testing and the personnel requirements for high-complexity testing. Laboratories that perform public health newborn screening are subject to the same CLIA regulations and applicable state requirements. As the number of inherited metabolic diseases that are included in state-based newborn screening programs continues to increase, ensuring the quality of performance and delivery of testing services remains a continuous challenge not only for public health laboratories and other newborn screening facilities but also for biochemical genetic testing laboratories. To help ensure the quality of laboratory testing, CDC collaborated with the Centers for Medicare & Medicaid Services, the Food and Drug Administration, the Health Resources and Services Administration, and the National Institutes of Health to develop guidelines for laboratories to meet CLIA requirements and apply additional quality assurance measures for these areas of genetic testing. This report provides recommendations for good laboratory practices that were developed based on recommendations from the Clinical Laboratory Improvement Advisory Committee, with additional input from the Secretary's Advisory Committee on Genetics, Health, and Society; the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; and representatives of newborn

  10. Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa

    PubMed Central

    Shott, Joseph P.; Saye, Renion; Diakité, Moussa L.; Sanogo, Sintry; Dembele, Moussa B.; Keita, Sekouba; Nagel, Mary C.; Ellis, Ruth D.; Aebig, Joan A.; Diallo, Dapa A.; Doumbo, Ogobara K.

    2012-01-01

    Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices. PMID:22492138

  11. Environmental monitoring programs vs Good Laboratory Practice (GLP) programs: differences and similarities.

    PubMed

    Bentley, R E

    1995-12-01

    Environmental monitoring and Good Laboratory Practice programs are similar when looked at empirically. Both address quality issues, human or environmental safety, and have set procedures to assure the concomitant results. However, when compared at the operational level, they can be best described as very different. Good Laboratory Practice programs deal basically with two governmental agencies and their divisions- the Environmental Protection Agency and Food and Drug Administration. These are administered from the federal level involving no state resources. These programs are objective driven with the procedures being defined in study plans, protocols, and standard operating procedures. The environmental monitoring testing programs deal with a profusion of federal legislation including CERCLA (also known as CLP), RCRA, CWA, CAA, SDWA, NPDES and others. These acts require analysis by specific procedures mandated by the statutes. States operate many of these programs and have been given the authority by the federal government. Many of the states require separate certifications to conduct these analyses. Environmental monitoring testing laboratories often must acquire multiple state certifications to participate in multiple state programs. This is not cost effective and often leads to conflicting requirements. Much of the direction for having a national certification program comes from problems associated with these state-operated programs. PMID:8890354

  12. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL)

    PubMed Central

    Todd, Christopher A.; Sanchez, Ana M.; Garcia, Ambrosia; Denny, Thomas N.; Sarzotti-Kelsoe, Marcella

    2014-01-01

    The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines. PMID:24120573

  13. 77 FR 36277 - Academic Development of a Training Program for Good Laboratory Practices in High Containment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-18

    ... HUMAN SERVICES Food and Drug Administration Academic Development of a Training Program for Good... the support of a Funding Opportunity Announcement (FOA) entitled ``Academic Development of a Training... Texas Medical Branch (UTMB) Galveston National Laboratory (GNL) for the development and...

  14. Good Practices for Hood Use.

    ERIC Educational Resources Information Center

    Mikell, William G.; Drinkard, William C.

    1984-01-01

    Describes safety practices for laboratory fume hoods based on certain assumptions of hood design and performance. Also discusses the procedures in preparing to work at a hood. A checklist of good hood practices is included. (JM)

  15. Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice

    PubMed Central

    Borgert, Christopher J.; Mihaich, Ellen M.

    2012-01-01

    Background: There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. Objective: We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. Method: We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Discussion: Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Conclusions: Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process. PMID:22343028

  16. [Measurement of natriuretic peptides in heart failure: the good laboratory and clinical practice].

    PubMed

    Kovács, L Gábor; Nyolczas, Noémi; Habon, Tamás; Sepp, Róbert; Piroth, Zsolt; Hajas, Ágota; Boncz, Imre; Tomcsányi, János; Kappelmayer, János; Merkely, Béla

    2015-08-01

    Cardiac natriuretic peptides (BNP, NT-proBNP) play a pivotal role in cardiovascular homeostasis, mainly due to their roles in vasodilatation, natriuresis, diuresis and due to their antiproliferative properties. Proper measurement of the natriuretic peptide levels may help differentiate between respiratory and cardiac forms of dyspnea, diagnose early forms of heart failure, evaluate severity of heart failure (prognosis) and monitor the efficacy of therapy. In many countries natriuretic peptide levels are being used as one of the earliest diagnostics tools to evaluate the involvement of the heart. Current theoretical and clinical data confirm the importance of natriuretic peptides in routine healthcare. These roles are clearly described in international recommendations and guidelines. In the current review the authors discuss the problems of the measurement of natriuretic peptides in Hungary, including several aspects related to laboratory medicine, cardiology and health economy. PMID:26211747

  17. A Lesson Plan for the Enhancement of Training and Research in Academia by the Adaptation and Adoption of Good Laboratory Practice Guidelines

    ERIC Educational Resources Information Center

    Sitaraman, Ramakrishnan

    2010-01-01

    The implementation of good laboratory practices (GLPs) is recognized by the biotechnology and pharmaceutical industries as being critical for ensuring the international acceptability of products. However, as universities and colleges (and research organizations) do not necessarily work under similar constraints, actual laboratory practices vary…

  18. Good Clinical Practice Training

    PubMed Central

    Arango, Jaime; Chuck, Tina; Ellenberg, Susan S.; Foltz, Bridget; Gorman, Colleen; Hinrichs, Heidi; McHale, Susan; Merchant, Kunal; Shapley, Stephanie; Wild, Gretchen

    2016-01-01

    Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The goal of GCP is to ensure the protection of the rights, integrity, and confidentiality of clinical trial participants and to ensure the credibility and accuracy of data and reported results. In the United States, trial sponsors generally require investigators to complete GCP training prior to participating in each clinical trial to foster GCP and as a method to meet regulatory expectations (ie, sponsor’s responsibility to select qualified investigators per 21 CFR 312.50 and 312.53(a) for drugs and biologics and 21 CFR 812.40 and 812.43(a) for medical devices). This training requirement is often extended to investigative site staff, as deemed relevant by the sponsor, institution, or investigator. Those who participate in multiple clinical trials are often required by sponsors to complete repeated GCP training, which is unnecessarily burdensome. The Clinical Trials Transformation Initiative convened a multidisciplinary project team involving partners from academia, industry, other researchers and research staff, and government to develop recommendations for streamlining current GCP training practices. Recommendations drafted by the project team, including the minimum key training elements, frequency, format, and evidence of training completion, were presented to a broad group of experts to foster discussion of the current issues and to seek consensus on proposed solutions. PMID:27390628

  19. Integrated data acquisition system for medical device testing and physiology research in compliance with good laboratory practices.

    PubMed

    Koenig, Steven C; Woolard, Cary; Drew, Guy; Unger, Lauren; Gillars, Kevin; Ewert, Dan; Gray, Laman; Pantalos, George

    2004-01-01

    In seeking approval from the US Food and Drug Administration (FDA) for clinical trial evaluation of an experimental medical device, a sponsor is required to submit experimental findings and support documentation to demonstrate device safety and efficacy that are in compliance with Good Laboratory Practices (GLP). The objective of this project was to develop an integrated data acquisition (DAQ) system and documentation strategy for monitoring and recording physiological data when testing medical devices in accordance with GLP guidelines mandated by the FDA. Data aquisition systems were developed as stand-alone instrumentation racks containing transducer amplifiers and signal processors, analog-to-digital converters for data storage, visual display and graphical user-interfaces, power conditioners, and test measurement devices. Engineering standard operating procedures (SOP) were developed to provide a written step-by-step process for calibrating, validating, and certifying each individual instrumentation unit and the integrated DAQ system. Engineering staff received GLP and SOP training and then completed the calibration, validation, and certification process for the individual instrumentation components and integrated DAQ system. Eight integrated DAQ systems have been successfully developed that were inspected by regulatory affairs consultants and determined to meet GLP guidelines. Two of these DAQ systems were used to support 40 of the pre-clinical animal studies evaluating the AbiCor artificial heart (ABIOMED, Danvers, MA). Based in part on these pre-clinical animal data, the AbioCor clinical trials began in July 2001. The process of developing integrated DAQ systems, SOP, and the validation and certification methods used to ensure GLP compliance are presented in this article. PMID:15174367

  20. [Drug flow. Good manufacturing practices, good clinical practices].

    PubMed

    Dupin-Spriet, T; Spriet, A

    1991-01-01

    On a worldwide basis, the drug development circuit in clinical trials undergoes a general movement towards improvement which is sensitive to the degree of quality. The methods used to achieve this are found at the interface of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). They consist primarily of two types, for which examples are given here: strengthening of controls (verification of the resemblance of test drugs in double-blind comparison by a "jury" and computerized systems of drug accountability), improvement in "compliance with therapy at the site of investigation" (use of more "intelligent" drug packages and labels). PMID:2020929

  1. Good Practice Recommendations in the Field of Heating, Ventilation, and Air Conditioning for Health Related Research Laboratories.

    ERIC Educational Resources Information Center

    Laboratory Design Notes, 1966

    1966-01-01

    A collection of laboratory design notes to set forth minimum criteria required in the design of basic medical research laboratory buildings. Recommendations contained are primarily concerned with features of design which affect quality of performance and future flexibility of facility systems. Subjects of economy and safety are discussed where…

  2. Practicing Good Habits, Grade 2.

    ERIC Educational Resources Information Center

    Nguyen Van Quan; And Others

    This illustrated primer, designed for second grade students in Vietnam, consists of stories depicting rural family life in Vietnam. The book is divided into the following six chapters: (1) Practicing Good Habits (health, play, helpfulness); (2) Duties at Home (grandparents, father and mother, servants, the extended family; (3) Duties in School…

  3. Practice Makes Pretty Good: Assessment of Primary Literature Reading Abilities across Multiple Large-Enrollment Biology Laboratory Courses

    ERIC Educational Resources Information Center

    Sato, Brian K.; Kadandale, Pavan; He, Wenliang; Murata, Paige M. N.; Latif, Yama; Warschauer, Mark

    2014-01-01

    Primary literature is essential for scientific communication and is commonly utilized in undergraduate biology education. Despite this, there is often little time spent "training" our students how to critically analyze a paper. To address this, we introduced a primary literature module in multiple upper-division laboratory courses. In…

  4. Practice makes pretty good: assessment of primary literature reading abilities across multiple large-enrollment biology laboratory courses.

    PubMed

    Sato, Brian K; Kadandale, Pavan; He, Wenliang; Murata, Paige M N; Latif, Yama; Warschauer, Mark

    2014-01-01

    Primary literature is essential for scientific communication and is commonly utilized in undergraduate biology education. Despite this, there is often little time spent training our students how to critically analyze a paper. To address this, we introduced a primary literature module in multiple upper-division laboratory courses. In this module, instructors conduct classroom discussions that dissect a paper as researchers do. While previous work has identified classroom interventions that improve primary literature comprehension within a single course, our goal was to determine whether including a scientific paper module in our classes could produce long-term benefits. On the basis of performance in an assessment exam, we found that our module resulted in longitudinal gains, including increased comprehension and critical-thinking abilities in subsequent lab courses. These learning gains were specific to courses utilizing our module, as no longitudinal gains were seen in students who had taken other upper-division labs that lacked extensive primary literature discussion. In addition, we assessed whether performance on our assessment correlated with a variety of factors, including grade point average, course performance, research background, and self-reported confidence in understanding of the article. Furthermore, all of the study conclusions are independent of biology disciplines, as we observe similar trends within each course. PMID:25452490

  5. Good practice statements on safe laboratory testing: A mixed methods study by the LINNEAUS collaboration on patient safety in primary care

    PubMed Central

    Bowie, Paul; Forrest, Eleanor; Price, Julie; Verstappen, Wim; Cunningham, David; Halley, Lyn; Grant, Suzanne; Kelly, Moya; Mckay, John

    2015-01-01

    ABSTRACT Background: The systems-based management of laboratory test ordering and results handling is a known source of error in primary care settings worldwide. The consequences are wide-ranging for patients (e.g. avoidable harm or poor care experience), general practitioners (e.g. delayed clinical decision making and potential medico-legal implications) and the primary care organization (e.g. increased allocation of resources to problem-solve and dealing with complaints). Guidance is required to assist care teams to minimize associated risks and improve patient safety. Objective: To identify, develop and build expert consensus on ‘good practice’ guidance statements to inform the implementation of safe systems for ordering laboratory tests and managing results in European primary care settings. Methods: Mixed methods studies were undertaken in the UK and Ireland, and the findings were triangulated to develop ‘good practice’ statements. Expert consensus was then sought on the findings at the wider European level via a Delphi group meeting during 2013. Results: We based consensus on 10 safety domains and developed 77 related ‘good practice’ statements (≥ 80% agreement levels) judged to be essential to creating safety and minimizing risks in laboratory test ordering and subsequent results handling systems in international primary care. Conclusion: Guidance was developed for improving patient safety in this important area of primary care practice. We need to consider how this guidance can be made accessible to frontline care teams, utilized by clinical educators and improvement advisers, implemented by decision makers and evaluated to determine acceptability, feasibility and impacts on patient safety. PMID:26339831

  6. Why Public Health Agencies Cannot Depend on Good Laboratory Practices as a Criterion for Selecting Data: The Case of Bisphenol A

    PubMed Central

    Myers, John Peterson; vom Saal, Frederick S.; Akingbemi, Benson T.; Arizono, Koji; Belcher, Scott; Colborn, Theo; Chahoud, Ibrahim; Crain, D. Andrew; Farabollini, Francesca; Guillette, Louis J.; Hassold, Terry; Ho, Shuk-mei; Hunt, Patricia A.; Iguchi, Taisen; Jobling, Susan; Kanno, Jun; Laufer, Hans; Marcus, Michele; McLachlan, John A.; Nadal, Angel; Oehlmann, Jörg; Olea, Nicolás; Palanza, Paola; Parmigiani, Stefano; Rubin, Beverly S.; Schoenfelder, Gilbert; Sonnenschein, Carlos; Soto, Ana M.; Talsness, Chris E.; Taylor, Julia A.; Vandenberg, Laura N.; Vandenbergh, John G.; Vogel, Sarah; Watson, Cheryl S.; Welshons, Wade V.; Zoeller, R. Thomas

    2009-01-01

    Background In their safety evaluations of bisphenol A (BPA), the U.S. Food and Drug Administration (FDA) and a counterpart in Europe, the European Food Safety Authority (EFSA), have given special prominence to two industry-funded studies that adhered to standards defined by Good Laboratory Practices (GLP). These same agencies have given much less weight in risk assessments to a large number of independently replicated non-GLP studies conducted with government funding by the leading experts in various fields of science from around the world. Objectives We reviewed differences between industry-funded GLP studies of BPA conducted by commercial laboratories for regulatory purposes and non-GLP studies conducted in academic and government laboratories to identify hazards and molecular mechanisms mediating adverse effects. We examined the methods and results in the GLP studies that were pivotal in the draft decision of the U.S. FDA declaring BPA safe in relation to findings from studies that were competitive for U.S. National Institutes of Health (NIH) funding, peer-reviewed for publication in leading journals, subject to independent replication, but rejected by the U.S. FDA for regulatory purposes. Discussion Although the U.S. FDA and EFSA have deemed two industry-funded GLP studies of BPA to be superior to hundreds of studies funded by the U.S. NIH and NIH counterparts in other countries, the GLP studies on which the agencies based their decisions have serious conceptual and methodologic flaws. In addition, the U.S. FDA and EFSA have mistakenly assumed that GLP yields valid and reliable scientific findings (i.e., “good science”). Their rationale for favoring GLP studies over hundreds of publically funded studies ignores the central factor in determining the reliability and validity of scientific findings, namely, independent replication, and use of the most appropriate and sensitive state-of-the-art assays, neither of which is an expectation of industry-funded GLP

  7. Good Laboratory Practice (GLP) status of Asian countries and its implementation in non-clinical safety studies in pharmaceutical drug development.

    PubMed

    Sasaki, Madoka; Hinotsu, Shiro; Kawakami, Koji

    2009-10-01

    Non-clinical animal studies to assess the safety of compounds under development have to comply with Good Laboratory Practice (GLP). The Organization for Economic Co-operation and Development (OECD) has established the Mutual Acceptance of Data (MAD) system in OECD member countries for the mutual acceptance of non-clinical safety study data. Since 1997 non-OECD-member countries have also been able to participate in the MAD system, if the country meets the level of standardized compliance with OECD GLP. Thus, several Asian non-OECD countries are trying to develop their GLP standards in order to become official members of the MAD system. Pharmaceutical companies face significant expense in the drug-development process, including the cost of non-clinical safety studies; in response, companies in Asian countries are seeking to establish GLP facilities to provide cost-effective services for drug development. To assess the quality and cost of GLP performance in Asian countries, in this study we approached GLP facilities in a number of Asian countries to obtain price and quality information on a 'virtual compound' to be assessed in non-clinical safety studies. Also, the development status of GLP in Asian countries in terms of policy and infrastructure was analyzed. We found that, among Asian countries, India and Singapore may be candidates for participation in te MAD system in terms of their compliance with GLP, language, and costs. These findings will be beneficial to pharmaceutical companies planning GLP studies in Asian countries. PMID:19797857

  8. [External quality assessment for clinical microbiology and good laboratory management].

    PubMed

    Kumasaka, K

    1998-02-01

    The Tokyo Metropolitan external quality assessment (EQA) program has revealed some serious problems in private independent microbiology laboratories in Tokyo since 1982. The poor performance in the EQA surveys closely related to poor laboratory managements, the type of training, experience of the medical technologists or technicians, and supervisory ability of the consultant physicians in independent laboratories. Social factors impede the reform of the quality assurance of clinical microbiology. Such factors include poor infrastructure of continuing education for small private laboratories, closure of the central clinical laboratories in the hospitals and outsourcing of laboratory tests due to restructuring in response to economic problems, and limited numbers of certified clinical pathologists of the Japan Society of Clinical Pathology (JSCP). Therefore, the Tokyo Metropolitan EQA Scheme is still confidential and its main role is educational. Good two way communication between participants and the organizers' clinical pathologists is essential, if the quality of laboratory tests is to be improved. The new JSCP edition of the postgraduate training requirement in clinical pathology includes "Laboratory Administration and Management". Good laboratory management(GLM) is an increasingly important component of good laboratory practice. The practice activities of clinical pathologists must include general management in addition to exercising there specialized knowledge in medicine and technology. Whereas leadership of a good clinical pathologist provides the direction of where a good laboratory is going, good management provides the steps of how to get there. And I believe quality system models from business and industry may provide us with strong guidance to build a quality system for the good laboratory that will endure into the next century. PMID:9528335

  9. Practicing Good Habits, Grade 1.

    ERIC Educational Resources Information Center

    Huynh Cong Tu; And Others

    This primer, intended for use during the child's first year in elementary school in Vietnam, relates the story of the daily lives of Hong, age 10, and her brother Lac, age 7, at home and at school. The 64 lessons are divided into four chapters: (1) Good Habits (personal hygiene, grooming, dressing, obedience, truthfulness); (2) At Home: Father and…

  10. Integrating Education: Parekhian Multiculturalism and Good Practice

    ERIC Educational Resources Information Center

    McGlynn, Claire

    2009-01-01

    This paper explores the concept of good practice in integrating education in divided societies. Using Northern Ireland as a case study, the paper draws on data from eight schools (both integrated Catholic and Protestant, and separate) that are identified as exemplifying good practice in response to cultural diversity. Analysis is provided through…

  11. Good documentation practice in clinical research

    PubMed Central

    Bargaje, Chitra

    2011-01-01

    One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This article focuses on the key principles of good documentation practice and offers suggestions for improvement. PMID:21731856

  12. Good Law, Good Practice, Good Sense: Using Legal Guidelines for Drafting Educational Policies.

    ERIC Educational Resources Information Center

    Bogotch, Ira E.

    1988-01-01

    Suggests how to use legal guidelines for drafting educational policies. Analyzes the political context in which present policymaking and governance initiatives exist. Two assumptions frame this article. First, good law makes for good administrative practice. Second, administrator policymaking is more important than the content of the policy…

  13. Alternative Pathways to Apprenticeships. Good Practice Guide

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2015

    2015-01-01

    Apprenticeships are changing. The increasing proportions of people entering apprenticeships at various levels of ability and backgrounds are stimulating demand for alternative pathways to completions. This good practice guide assembles the key findings for education practitioners and workplace supervisors from three related research reports on…

  14. [New guidelines on good scientific practice].

    PubMed

    Nielsen, Ole Haagen

    2009-05-25

    In 2009 the Danish Committees on Scientific Dishonesty released their new guidelines on good scientific practice (i.e. responsible conduct of research) with a particular focus on healthcare. These guidelines are intended to help Danish researchers avoid any discreditability of their scientific work, and especially to improve the general standard of their research. PMID:19486614

  15. Tourism. Leonardo da Vinci Series: Good Practices.

    ERIC Educational Resources Information Center

    Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

    This brochure, part of a series about good practices in vocational training in the European Union, describes 10 projects that have promoted investment in human resources through training in the tourism sector to promote sustainable, or responsible, tourism. The projects and their countries of origin are as follows: (1) BEEFT, training of mobility…

  16. Guide to good practices for shift routines and operating practices

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, ``Shift Routines and Operating Practices,`` Chapter 2 of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing shift routines and operating practices. ``Shift Routines and Operating Practices`` is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for a high standard of professional conduct and sound operating practices to promote safe and efficient operations. Recently, guidance pertaining to this element has been strengthened for nuclear power reactors. This additional guidance is given in Appendix C for information purposes. Though this guidance and good practices pertain to nuclear power reactors, DOE sites may choose to use a graded approach for implementing these in nuclear facilities.

  17. Practical Laboratory Planning.

    ERIC Educational Resources Information Center

    Ferguson, W. R.

    This book is intended as a guide for people who are planning chemistry and physics research laboratories. It deals with the importance of effective communication between client and architect, the value of preliminary planning, and the role of the project officer. It also discusses the size and layout of individual laboratories, the design of…

  18. Guide to good practices for operations turnover

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Operations Turnover, Chapter XII of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing operations turnover programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Operations Turnover is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for a formal operations turnover program to promote safe and efficient operations.

  19. Guide to good practices for independent verification

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Independent Verification, Chapter X of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing independent verification activities. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Independent Verification is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for coordinated independent verification activities to promote safe and efficient operations.

  20. Guide to good practices for communications

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Communications, Chapter 4 of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing communication programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. ``Communications`` is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for high reliability in communications to promote safe and efficient operations.

  1. Guide to good practices for logkeeping

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Logkeeping, Chapter XI of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing logkeeping programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Logkeeping is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the need for a consistent logkeeping program to promote safe and efficient operations.

  2. Editorial: A Note on Good Research Practice

    SciTech Connect

    Dooley, James J.

    2013-07-01

    Good scientific practice and research misconduct have been concerns of mine for more than a decade (Dooley and Kerch, 2000) and in my role as an editor of the International Journal of Greenhouse Gas Control, I feel it is time to speak up and at the very least share my concerns and suggestions as they relate to the integrity of the research published in this journal. Rather than wait to write an editorial on good research practices in response to a major incident, I thought it might be best to be proactive and address some of the trends we see in submissions to this peer reviewed journal and to offer some suggestions for improvement improving the level of scholarship in some – but by no means all – of the papers submitted.

  3. Good Practices in Free-energy Calculations

    NASA Technical Reports Server (NTRS)

    Pohorille, Andrew; Jarzynski, Christopher; Chipot, Christopher

    2013-01-01

    As access to computational resources continues to increase, free-energy calculations have emerged as a powerful tool that can play a predictive role in drug design. Yet, in a number of instances, the reliability of these calculations can be improved significantly if a number of precepts, or good practices are followed. For the most part, the theory upon which these good practices rely has been known for many years, but often overlooked, or simply ignored. In other cases, the theoretical developments are too recent for their potential to be fully grasped and merged into popular platforms for the computation of free-energy differences. The current best practices for carrying out free-energy calculations will be reviewed demonstrating that, at little to no additional cost, free-energy estimates could be markedly improved and bounded by meaningful error estimates. In energy perturbation and nonequilibrium work methods, monitoring the probability distributions that underlie the transformation between the states of interest, performing the calculation bidirectionally, stratifying the reaction pathway and choosing the most appropriate paradigms and algorithms for transforming between states offer significant gains in both accuracy and precision. In thermodynamic integration and probability distribution (histogramming) methods, properly designed adaptive techniques yield nearly uniform sampling of the relevant degrees of freedom and, by doing so, could markedly improve efficiency and accuracy of free energy calculations without incurring any additional computational expense.

  4. Trial of Integrated Laboratory Practice

    ERIC Educational Resources Information Center

    Matsuo, Osamu; Takahashi, Yuzo; Abe, Chikara; Tanaka, Kunihiko; Nakashima, Akira; Morita, Hironobu

    2011-01-01

    In most laboratory practices for students in medical schools, a laboratory guidebook is given to the students, in which the procedures are precisely described. The students merely follow the guidebook without thinking deeply, which spoils the students and does not entice them to think creatively. Problem-based learning (PBL) could be one means for…

  5. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Good guidance practices. 10.115 Section 10.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATIVE PRACTICES AND PROCEDURES General Administrative Procedures § 10.115 Good guidance practices. (a) What are good guidance practices? Good...

  6. Prakriti-based research: Good reporting practices.

    PubMed

    Bhalerao, Supriya; Patwardhan, Kishor

    2016-03-01

    The recent advances in the fields of genomics, personalized medicine, and Ayurveda have motivated many researchers to look at the relationship between Prakriti (phenotype-based Ayurveda constitution) and various objective biological parameters. As a result, a number of studies reporting such a relationship have made their way into mainstream scholarly journals. However, when it comes to the protocols that these workers follow to identify one's Prakriti, there are several issues that are yet to be resolved. In this communication, we propose a few reporting practices that such workers are required to be encouraged to follow, while submitting their work on Prakriti to scholarly journals. We have arranged this proposal under the following domains that may serve as a preliminary checklist in this context: The textual references, validation process, assessment of characters, scoring pattern, weightage assignment, criterion for expressing the final Prakriti type, and a need to publish the complete Prakriti-determination tool. We advocate that only if the workers in the field adhere to these good reporting practices, one will be able to draw meaningful, generalizable, and applicable interpretations out of such studies. We also suggest that the editors of relevant scholarly journals may recommend these reporting practices while considering such reports for publication. PMID:27297513

  7. Guide to good practices for continuing training

    SciTech Connect

    Not Available

    1993-02-01

    The purpose of this Guide to Good Practices for Continuing Training is to provide contractor training organizations with information and methods useful in the development and implementation of a continuing training program. DOE Order 5480.18A, ``Accreditation of Performance-Based Training for Category A Reactors and Nuclear Facilities,`` and DOE Order 5480.20, ``Personnel Selection, Qualification and Training Requirements at DOE Reactor and Non-reactor Nuclear Facilities`` Chapter 1, Paragraph 7, require each facility to design and implement a continuing training program. Continuing training is necessary to ensure that facility personnel continually improve their ability to operate and maintain their facility in a safe and reliable manner. Continuing training also should enhance the professionalism of these individuals and should make them aware of the possible consequences of misoperation.

  8. Good operating practices cut water pollution

    SciTech Connect

    West, D.E.

    1982-07-12

    This paper explains how the pipeline industry can avoid violating the Clean Water Act (PL 92-500, Federal Water Pollution Control Act), which states that pollution of US waters from any cause other than an act of God, war or Government negligence is the responsibility of the owner or operator of the facility. Reporting pollution to the National Response Center will limit the maximum penalty to $5,000 Rectifiers must be kept in top operating condition, and visual inspections of the right-of-way by aerial or ground patrols must detect construction of new pipelines or other facilities. Accidental damage by third parties is the major cause of failures in pipeline systems, which can be prevented by periodic contact with landowners. Conclusion is that if a pipeline operator follows good operating and maintenance practices, his exposure to effects of the Clean Water Act will be minimal.

  9. Good practice in multimedia courseware development.

    PubMed

    Schulz, C

    1998-01-01

    The main goal of the European TALENT/ESPRIT project is to create a generic environment for developing multimedia courseware. The first phase of the project concerns itself with developing conversion tools for converting text based course material into multimedia format. The second phase of the project adds network support to the courseware in the form of the network tutoring and networked supply chain support. One year into the project specifications for developing multimedia have been made and can be found in the project's deliverables. Also a summary of good practice in multimedia courseware development has been drawn up. First phase demonstrators (converted text based courses) are currently being prepared. This article starts with a global overview of the TALENT project itself. In more detail an overview of best practice guidelines in multimedia courseware development will be given. The information shown was obtained from an extensive survey among experts in the field of computer based training. The survey was conducted early this year as part of one of the project's deliverables. Finally some comments will be made on a multimedia demonstrator which is currently under development at HISCOM. PMID:10179628

  10. 76 FR 9025 - Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

    ... manufacturers of food additives, human drugs and biological products, animal drugs, and medical devices to... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies AGENCY: Food...

  11. Scientific dishonesty and good scientific practice.

    PubMed

    Andersen, D; Axelsen, N H; Riis, P

    1993-04-01

    Scientific dishonesty has been the subject of much public interest in recent years. Although the problem has had a low profile in Denmark, there is no reason to believe that it is non-existent. Several preconditions known to be important prevail here as well as in other countries, such as pressure to publish and severe competition for research grants and senior academic positions. The Danish Medical Research Council (DMRC) decided to respond to this problem by preparing a report on scientific dishonesty with suggestions to the research institutions on rules for good scientific practice and procedures for investigation of suspected dishonesty. To this end, an investigatory system was suggested. The system should consist of two regional committees and one national committee. They should be headed by high court judges and experienced health sciences researchers as members. The committees will investigate cases reported to them and conclude on whether dishonesty has been established and on whether the scientific work should be retracted. Sanctions shall remain the task of the institutions. Preventive measures comprise open access to and a long storage period for scientific data. PMID:8495601

  12. Defense programs beryllium good practice guide

    SciTech Connect

    Herr, M.

    1997-07-01

    Within the DOE, it has recently become apparent that some contractor employees who have worked (or are currently working) with and around beryllium have developed chronic beryllium disease (CBD), an occupational granulomatous lung disorder. Respiratory exposure to aerosolized beryllium, in susceptible individuals, causes an immunological reaction that can result in granulomatous scarring of the lung parenchyma, shortness of breath, cough, fatigue, weight loss, and, ultimately, respiratory failure. Beryllium disease was originally identified in the 1940s, largely in the fluorescent light industry. In 1950, the Atomic Energy Commission (AEC) introduced strict exposure standards that generally curtailed both the acute and chronic forms of the disease. Beginning in 1984, with the identification of a CBD case in a DOE contractor worker, there was increased scrutiny of both industrial hygiene practices and individuals in this workforce. To date, over 100 additional cases of beryllium-specific sensitization and/or CBD have been identified. Thus, a disease previously thought to be largely eliminated by the adoption of permissible exposure standards 45 years ago is still a health risk in certain workforces. This good practice guide forms the basis of an acceptable program for controlling workplace exposure to beryllium. It provides (1) Guidance for minimizing worker exposure to beryllium in Defense Programs facilities during all phases of beryllium-related work, including the decontamination and decommissioning (D&D) of facilities. (2) Recommended controls to be applied to the handling of metallic beryllium and beryllium alloys, beryllium oxide, and other beryllium compounds. (3) Recommendations for medical monitoring and surveillance of workers exposed (or potentially exposed) to beryllium, based on the best current understanding of beryllium disease and medical diagnostic tests available. (4) Site-specific safety procedures for all processes of beryllium that is likely to

  13. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Current good tissue practice requirements. 1271... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150 Current good tissue practice requirements. (a) General. This subpart D and subpart C of this part...

  14. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Current good manufacturing practice. 226.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES General Provisions § 226.1 Current good manufacturing practice. (a) The criteria in §§ 226.10 through 226.115,...

  15. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Current good tissue practice requirements. 1271... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150 Current good tissue practice requirements. (a) General. This subpart D and subpart C of this part...

  16. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Current good manufacturing practice. 226.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES General Provisions § 226.1 Current good manufacturing practice. (a) The criteria in §§ 226.10 through 226.115,...

  17. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Current good manufacturing practice. 226.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES General Provisions § 226.1 Current good manufacturing practice. (a) The criteria in §§ 226.10 through 226.115,...

  18. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Current good manufacturing practice. 225.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS General Provisions § 225.1 Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic...

  19. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Current good manufacturing practice. 225.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS General Provisions § 225.1 Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic...

  20. 21 CFR 110.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 110.5 Section...) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General Provisions § 110.5 Current good manufacturing practice. (a) The criteria...

  1. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Current good tissue practice requirements. 1271... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150 Current good tissue practice requirements. (a) General. This subpart D and subpart C of this part...

  2. 21 CFR 110.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 110.5 Section...) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General Provisions § 110.5 Current good manufacturing practice. (a) The criteria...

  3. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Current good tissue practice requirements. 1271... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150 Current good tissue practice requirements. (a) General. This subpart D and subpart C of this part...

  4. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Current good tissue practice requirements. 1271... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150 Current good tissue practice requirements. (a) General. This subpart D and subpart C of this part...

  5. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Current good manufacturing practice. 226.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES General Provisions § 226.1 Current good manufacturing practice. (a) The criteria in §§ 226.10 through 226.115,...

  6. 21 CFR 110.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 110.5 Section...) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General Provisions § 110.5 Current good manufacturing practice. (a) The criteria...

  7. 21 CFR 110.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 110.5 Section...) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General Provisions § 110.5 Current good manufacturing practice. (a) The criteria...

  8. 21 CFR 110.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 110.5 Section...) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General Provisions § 110.5 Current good manufacturing practice. (a) The criteria...

  9. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Current good manufacturing practice. 225.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS General Provisions § 225.1 Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic...

  10. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Current good manufacturing practice. 225.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS General Provisions § 225.1 Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic...

  11. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Current good manufacturing practice. 226.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES General Provisions § 226.1 Current good manufacturing practice. (a) The criteria in §§ 226.10 through 226.115,...

  12. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Current good manufacturing practice. 225.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS General Provisions § 225.1 Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic...

  13. Concepts for a model of good medical laboratory services.

    PubMed

    Haeckel, R; Böhm, M; Capel, P J; Høiby, N; Jansen, R T; Kallner, A; Kelly, A; Kruse-Jarres, J D; Küffer, H; Libeer, J C

    1998-06-01

    Several international standards and corresponding interpretation documents for quality management systems have been published. Although these standards are found useful to some extent, they are considered to be insufficient in several areas important for medical laboratories particularly in the pre- and post-examinational phases. The normative document for accreditation of laboratories (ISO/IEC Guide 25) is presently being revised and a document for medical laboratories (ISO/TC 212, CD 15189) is at draft stage. Both aim to include aspects of total quality management. The concept of total quality management is rather vague. Generally, its goal has been defined as "business excellence". This term, however, needs some explanation if applied to medical laboratories. Therefore, a project group of the European Confederation of Laboratory Medicine (ECLM) has developed a model for total quality management, which is based on a comprehensive management concept issued by the European Foundation for Quality Management. In the case of a medical laboratory, the term "business excellence" should be replaced by "good medical laboratory services". The proposed model could serve as a basis for future developments of total quality management standards in laboratory medicine. The goal of the "journey" should be clarified before it starts. To the best of our knowledge, this is the first attempt to develop a model of a good medical laboratory. PMID:9711429

  14. Quality in pathology laboratory practice.

    PubMed

    Weinstein, S

    1995-06-01

    Quality refers not only to analytical quality control, a traditional area of laboratory excellence, but to the entire science of quality management. As measures of quality, structural indicators refer to staffing and physical facilities, process indicators to the institutions operations and, perhaps most importantly, outcome indicators address the ultimate patient care uses that pathology information is put to. Comparison of performance to peer laboratories, external quality control, is a practical, if limited, yardstick of performance. Customer satisfaction and turn-around-time of tests are receiving more recent attention as quality measures. Blood banking, because of its inherently complex cycle from donor phlebotomy to product infusion, requires special considerations with regard to quality management. Reporting of anatomical pathology, where the only gold standard is a consensus of experts, also does not lend itself to classical numerical quality assessment. PMID:7670717

  15. 21 CFR 129.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 129.1 Section... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as the... manufacturing practice to assure that bottled drinking water is safe and that it has been processed,...

  16. Promoting Good Statistical Practices: Some Suggestions.

    ERIC Educational Resources Information Center

    Kirk, Roger E.

    2001-01-01

    Makes the case that science is best served when researchers focus on the size of effects and their practical significance. Advocates the use of confidence intervals for deciding whether chance or sampling variability is an unlikely explanation for an observed effect. Calls for more emphasis on effect sizes in the next edition of the American…

  17. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10,...

  18. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10,...

  19. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Provisions § 120.5 Current good manufacturing practice. Part 110 of this chapter applies in...

  20. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Provisions § 120.5 Current good manufacturing practice. Part 110 of this chapter applies in...

  1. 21 CFR 129.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 129.1 Section 129.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as...

  2. 21 CFR 129.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 129.1 Section 129.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as...

  3. 21 CFR 129.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 129.1 Section 129.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as...

  4. 21 CFR 129.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 129.1 Section 129.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as...

  5. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10,...

  6. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Provisions § 120.5 Current good manufacturing practice. Part 110 of this chapter applies in...

  7. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Provisions § 120.5 Current good manufacturing practice. Part 110 of this chapter applies in...

  8. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10,...

  9. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 4 2012-10-01 2012-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Noncommercial Educational FM Broadcast Stations § 73.508 Standards of good engineering practice. (a) All...

  10. The Management of Student Administration: A Guide to Good Practice.

    ERIC Educational Resources Information Center

    Higher Education Funding Council for Wales, Cardiff.

    This report is intended to help institutions review their arrangements for student administration through comparisons with generally recognized good practice and with specific developments and experience in the sector. This study from which the information on good practices was derived was conducted through visits to 11 pilot institutions to…

  11. 21 CFR 123.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 123.5 Section...) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current good manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities,...

  12. A summarized discussion of current good manufacturing practice regulations.

    PubMed

    Allen, Loyd V

    2013-01-01

    In light of recent events and discussions of compounding pharmacy, it is important to discuss and understand the purpose of good manufacturing practices. This article provides a summary of the current Good Manufacturing Practice Regulations which were established by the U.S. Food and Drug Administration. PMID:24046937

  13. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Provisions § 120.5 Current good manufacturing practice. Part 110 of this chapter applies in...

  14. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10,...

  15. Understanding Graduate School Aspirations: The Effect of Good Teaching Practices

    ERIC Educational Resources Information Center

    Hanson, Jana M.; Paulsen, Michael B.; Pascarella, Ernest T.

    2016-01-01

    This study examined the effects of good teaching practices on post-baccalaureate degree aspirations using logistic regression techniques on a multi-institutional, longitudinal sample of students at 4-year colleges and universities in the USA. We examined whether eight good teaching practices (non-classroom interactions with faculty, prompt…

  16. Handbook of Science Laboratory Practices and Safety. Revised.

    ERIC Educational Resources Information Center

    Fredrickson, Clifford T.

    This handbook, written specially for the San Diego Public School System, contains detailed discussions on first aid, good laboratory practices, safety in the laboratory, and laws regulating the care and use of animals. The section on "First Aid" presents, in addition to standard first aid information, a discussion of first-aid kits for field trips…

  17. Top 10 metrics for life science software good practices

    PubMed Central

    2016-01-01

    Metrics for assessing adoption of good development practices are a useful way to ensure that software is sustainable, reusable and functional. Sustainability means that the software used today will be available - and continue to be improved and supported - in the future. We report here an initial set of metrics that measure good practices in software development. This initiative differs from previously developed efforts in being a community-driven grassroots approach where experts from different organisations propose good software practices that have reasonable potential to be adopted by the communities they represent. We not only focus our efforts on understanding and prioritising good practices, we assess their feasibility for implementation and publish them here.

  18. [What everybody should know about good clinical practices].

    PubMed

    Osorio, Lyda

    2015-06-01

    An increasing number of countries are adopting good clinical practices guidelines as part of the regulation of clinical studies to register pharmaceutical products and other health-related products. Consequently, all parties involved in the research and development of these products should know them, implement them and ensure their compliance. However, good clinical practices guidelines are just one of the initiatives seeking to achieve the highest ethical and scientific standards in health research and in other areas where humans are research subjects. This review defines such practices and their objectives presenting in a practical manner their legal framework in Colombia, and clarifying their application in studies where interventions use no medications or those that are not clinical trials. Finally, the work discusses the challenges to ensure that good clinical practices contribute to the protection of research participants, the education of trustworthy health professionals, and a culture of respect for human beings. PMID:26535550

  19. 21 CFR 114.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 114.5 Section 114.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good...

  20. 21 CFR 114.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 114.5 Section 114.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good...

  1. 21 CFR 114.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 114.5 Section 114.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good...

  2. 21 CFR 114.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 114.5 Section 114.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good...

  3. 21 CFR 114.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 114.5 Section 114.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good...

  4. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than...

  5. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 4 2014-10-01 2014-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than...

  6. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 4 2013-10-01 2013-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than...

  7. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 4 2011-10-01 2011-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than...

  8. Sharing Good Practice through Mash-Up Personal Learning Environments

    NASA Astrophysics Data System (ADS)

    Mödritscher, Felix; Wild, Fridolin

    Personal learning environments (PLEs) require new ways to motivate and scaffold learners. In particular, practice sharing is of importance for learnercentric approaches in the scope of (technology-enhanced) lifelong learning, as it is an enabler for community building and sustaining. In this paper we elaborate prerequisites for ‘good practice sharing’ and explain how we realized these aspects in our PLE solution named Mash-Up Personal Learning Environments (MUPPLE.org). Finally, we argue for the utility of our MUPPLE approach by highlighting two different strategies of good practice sharing and their benefits for learning and community building.

  9. Guide to good practices for the development of test items

    SciTech Connect

    1997-01-01

    While the methodology used in developing test items can vary significantly, to ensure quality examinations, test items should be developed systematically. Test design and development is discussed in the DOE Guide to Good Practices for Design, Development, and Implementation of Examinations. This guide is intended to be a supplement by providing more detailed guidance on the development of specific test items. This guide addresses the development of written examination test items primarily. However, many of the concepts also apply to oral examinations, both in the classroom and on the job. This guide is intended to be used as guidance for the classroom and laboratory instructor or curriculum developer responsible for the construction of individual test items. This document focuses on written test items, but includes information relative to open-reference (open book) examination test items, as well. These test items have been categorized as short-answer, multiple-choice, or essay. Each test item format is described, examples are provided, and a procedure for development is included. The appendices provide examples for writing test items, a test item development form, and examples of various test item formats.

  10. Health physics manual of good practices for tritium facilities

    SciTech Connect

    Blauvelt, R.K.; Deaton, M.R.; Gill, J.T.

    1991-12-01

    The purpose of this document is to provide written guidance defining the generally accepted good practices in use at Department of Energy (DOE) tritium facilities. A {open_quotes}good practice{close_quotes} is an action, policy, or procedure that enhances the radiation protection program at a DOE site. The information selected for inclusion in this document should help readers achieve an understanding of the key radiation protection issues at tritium facilities and provide guidance as to what characterizes excellence from a radiation protection point of view. The ALARA (As Low as Reasonable Achievable) program at DOE sites should be based, in part, on following the good practices that apply to their operations.

  11. Nursing practice: compassionate deception and the Good Samaritan.

    PubMed

    Tuckett, A

    1999-09-01

    This article reviews the literature on deception to illuminate the phenomenon as a background for an appraisal within nursing. It then describes nursing as a practice of caring. The character of the Good Samaritan is recommended as indicative of the virtue of compassion that ought to underpin caring in nursing practice. Finally, the article concludes that a caring nurse, responding virtuously, acts by being compassionate, for a time recognizing the prima facie nature of the rules or principles of truth telling. PMID:10696185

  12. Guide to good practices for operator aid postings

    SciTech Connect

    Not Available

    1993-06-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Operator Aid Postings, Chapter XVII of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities.'' The practices in this guide should be considered when planning or reviewing operator aid postings. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19.

  13. Robust data enables managers to promote good practice.

    PubMed

    Bassett, Sally; Westmore, Kathryn

    2012-11-01

    This is the third in a series of articles examining the components of good corporate governance. The effective and efficient use of information and sources of information is crucial for good governance. This article explores the ways in which boards and management can obtain and use information to monitor performance and promote good practice, and how boards can be assured about the quality of information on which they rely. The final article in this series will look at the role of accountability in corporate governance. PMID:23189532

  14. Putting New Laboratory Tests Into Practice

    MedlinePlus

    ... limited. Home Visit Global Sites Search Help? Putting New Laboratory Tests into Practice Share this page: Was this page helpful? Introduction | Why develop new tests | Regulation | Gaining acceptance | Conclusion | Article Sources Overview ...

  15. Knowledge Gained from Good Agricultural Practices Courses for Iowa Growers

    ERIC Educational Resources Information Center

    Shaw, Angela; Strohbehn, Catherine; Naeve, Linda; Domoto, Paul; Wilson, Lester

    2015-01-01

    Good Agricultural Practices (GAP) educational courses provide produce growers with the fundamental information for producing and processing safe produce. To determine the effectiveness of the current 7-hour GAP course provided in Iowa, growers were surveyed before and 7-14 days after the course to determine changes in knowledge and opinions.…

  16. VET Providers Planning to Deliver Degrees: Good Practice Guide

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2015

    2015-01-01

    This good practice guide is intended to assist public and private registered training organisations (RTOs) planning to commence higher education (HE) delivery. The guide is based on research undertaken by Victor Callan and Kaye Bowman, who completed case studies with six providers currently delivering higher education qualifications in addition to…

  17. Implementing HR Strategies: A Guide to Good Practice.

    ERIC Educational Resources Information Center

    Higher Education Funding Council for England, Bristol.

    This guide aims to help institutions of higher education in England develop and implement their human resources (HR) strategies. It provides advice and examples of good practice in key areas, in response to requests from institutions. The report supplements earlier guidance on developing HR strategies (March 2002) and presents information for…

  18. Guide to good practices for developing learning objectives. DOE guideline

    SciTech Connect

    Not Available

    1992-07-01

    This guide to good practices provides information and guidance on the types of, and the development of learning objectives in performance-based training system at reactor and nonreactor nuclear facilities. Contractors are encouraged to consider this guidance as a reference when developing new learning objectives or refining existing ones. Training managers, designers, developers, and instructors are the intended audiences.

  19. 21 CFR 123.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 123.5 Section 123.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current...

  20. 21 CFR 123.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 123.5 Section 123.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current...

  1. 21 CFR 123.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 123.5 Section 123.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current...

  2. 21 CFR 123.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 123.5 Section 123.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current...

  3. DEVELOPMENT OF GOOD COMBUSTION PRACTICE FOR MUNICIPAL WASTE COMBUSTORS

    EPA Science Inventory

    The paper summarizes the rationale for EPA's good combustion practice (GCP) strategy. OTE: The EPA is developing new air pollution rules for all new and existing municipal waste combustors (MWCs), rules requiring all MWCs to use GCP. The goals of GCP are to maximize furnace destr...

  4. Understanding Graduate School Aspirations: The Effect of Good Teaching Practices

    ERIC Educational Resources Information Center

    Hanson, Jana Marie

    2013-01-01

    This study examined the effects of good teaching practices on post-baccalaureate degree aspirations using logistic regression techniques on a multi-institutional, longitudinal sample of students at four-year colleges and universities. Using College Choice and College Outcomes models as a theoretical foundation, I examined whether eight good…

  5. Seven Principles for Good Practice in Distance Learning.

    ERIC Educational Resources Information Center

    Tulloch, Jacquelyn

    As enrollments decline, many institutions rush to implement distance education programs, often with only crude or solely administrative guidelines for program development. The following seven principles of good practice can be useful to guide initial program development: (1) programs should have purpose, direction, leadership, and clearly…

  6. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Good guidance practices. 10.115 Section 10.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... office level or if you feel that you are not making progress by going through the chain of command,...

  7. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Good guidance practices. 10.115 Section 10.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... office level or if you feel that you are not making progress by going through the chain of command,...

  8. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Good guidance practices. 10.115 Section 10.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... office level or if you feel that you are not making progress by going through the chain of command,...

  9. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Good guidance practices. 10.115 Section 10.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... office level or if you feel that you are not making progress by going through the chain of command,...

  10. Successful Tutoring: Good Practice for Managers and Tutors.

    ERIC Educational Resources Information Center

    Green, Muriel

    This document, which draws on the findings of a survey of further education (FE) colleges in the United Kingdom and case studies of 9 FE colleges, presents good practices for managers of tutoring programs and tutors. Chapter 1 provides an overview of the changing role of tutors in the post-16 sector and the importance of recruiting, training, and…

  11. Guide to good practices for developing learning objectives. DOE Handbook

    SciTech Connect

    1992-07-01

    This guide to good practices provides information and guidance on the types of and development of learning objectives in a systematic approach to training program. This document can serve as a reference during the development of new learning objectives or refinement of existing ones.

  12. Student Accommodation Projects: A Guide to PFI Contracts. Good Practice.

    ERIC Educational Resources Information Center

    Curtis, Pinsent

    This guide is intended for higher education institutions in England that are about to embark on student residential accommodation projects. It focuses on procurements under the Private Financial Initiative (PFI), a form of Public Private Partnership in the United Kingdom, but other approaches are considered. The guide draws on good practices from…

  13. Good Practice in GNVQ Induction Programmes. Project Report.

    ERIC Educational Resources Information Center

    Benett, Yves

    A 2-year research and development project was conducted to identify existing good practices for introducing students in the United Kingdom (UK) to General National Vocational Qualifications (GNVQs) and available teaching and learning materials for use in the induction of GNVQs in UK schools and colleges. The main activities of the project's three…

  14. Standards of Good Practice for Education Abroad. Fourth Edition

    ERIC Educational Resources Information Center

    Forum on Education Abroad, 2011

    2011-01-01

    This fourth edition of the Forum on Education Abroad's "Standards of Good Practice for Education Abroad" augments previous editions of the "Standards." Since the last edition was published in 2008, Forum member institutions and organizations have implemented the Standards in program development and assessment, using the Standards in the Forum's…

  15. Beyond Responsiveness: Promoting Good Practice in Economic Development.

    ERIC Educational Resources Information Center

    Hughes, Maria; Kypri, Photoula

    1998-01-01

    This paper looks at the involvement of further education (FE) colleges in England and Wales in economic development and presents case studies of good practice in nine FE colleges. Chapter 1 addresses FE's role in economic development and measuring and planning economic growth. Chapter 2 contains the case studies: Lewisham College's Action for…

  16. Distance Learning. Leonardo da Vinci Series: Good Practices.

    ERIC Educational Resources Information Center

    Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

    This brochure, part of a series about good practices in vocational training in the European Union, describes 12 projects that use distance learning to promote lifelong learning in adults. The projects and their countries of origin are as follows: (1) 3D Project, training in the use of IT tools for 3D simulation and animation and practical…

  17. Laboratory Practical Work as a Technological Process.

    ERIC Educational Resources Information Center

    Pich-Otero, Augusto; Molina-Ortiz, Sara; Delaplace, Laura; Castellani, Oscar; Hozbor, Daniela; Sorgentini, Delia; Lodeiro, Anibal

    1998-01-01

    Evaluates the traditional method of intercalating theoretical and seminar classes with laboratory practical work. Proposes a new schedule where students get problem-based learning of theoretical concepts during the first half of the course, and plan and execute a laboratory project during the second half. (Author/CCM)

  18. Clinical audit: Development of the criteria of good practices.

    PubMed

    Soimakallio, S; Alanen, A; Järvinen, H; Ahonen, A; Ceder, K; Lyyra-Laitinen, T; Paunio, M; Sinervo, T; Wigren, T

    2011-09-01

    Clinical audit is a systematic review of the procedures in order to improve the quality and the outcome of patient care, whereby the procedures are examined against agreed standards for good medical RADIOLOGICAL procedures. The criteria of good procedures (i.e. the good practice) are thus the cornerstones for development of clinical audits: these should be the basis of assessments regardless of the type of the audit--external, internal, comprehensive or partial. A lot of criteria for good practices are available through the recommendations and publications by international and national professional societies and other relevant organisations. For practical use in clinical audits, the criteria need to be compiled, sorted out and agreed on for the particular aims of an audit (comprehensive or partial, external or internal). The national professional and scientific societies can provide valuable contribution to this development. For examination--or treatment-specific criteria--preliminary consensus needs to be obtained with the help of clinical experts, while clinical audits can be useful as a benchmarking tool to improve the criteria. PMID:21979432

  19. Management Documentation: Indicators & Good Practice at Cultural Heritage Places

    NASA Astrophysics Data System (ADS)

    Eppich, R.; Garcia Grinda, J. L.

    2015-08-01

    Documentation for cultural heritage places usually refers to describing the physical attributes, surrounding context, condition or environment; most of the time with images, graphics, maps or digital 3D models in their various forms with supporting textural information. Just as important as this type of information is the documentation of managerial attributes. How do managers of cultural heritage places collect information related to financial or economic well-being? How are data collected over time measured, and what are significant indicators for improvement? What quality of indicator is good enough? Good management of cultural heritage places is essential for conservation longevity, preservation of values and enjoyment by the public. But how is management documented? The paper will describe the research methodology, selection and description of attributes or indicators related to good management practice. It will describe the criteria for indicator selection and why they are important, how and when they are collected, by whom, and the difficulties in obtaining this information. As importantly it will describe how this type of documentation directly contributes to improving conservation practice. Good practice summaries will be presented that highlight this type of documentation including Pamplona and Ávila, Spain and Valletta, Malta. Conclusions are drawn with preliminary recommendations for improvement of this important aspect of documentation. Documentation of this nature is not typical and presents a unique challenge to collect, measure and communicate easily. However, it is an essential category that is often ignored yet absolutely essential in order to conserve cultural heritage places.

  20. A model for reflection for good clinical practice.

    PubMed

    Balla, John I; Heneghan, Carl; Glasziou, Paul; Thompson, Matthew; Balla, Margaret E

    2009-12-01

    Rationale and aim The rapidly changing knowledge base of clinical practice highlights the need to keep abreast of knowledge changes that are most relevant for the practitioner. We aimed to develop a model for reflection on clinical practice that identified the key elements of medical knowledge needed for good medical practice. Method The dual theory of cognition, an integration of intuitive and analytic processes, provided the framework for the study. The design looked at the congruence between the clinical thinking process and the dual theory. A one-year study was conducted in general practice clinics in Oxfordshire, UK. Thirty-five general practitioners participated in 20-minute interviews to discuss how they worked through recently seen clinical cases. Over a one-year period 72 cases were recorded from 35 interviews. These were categorized according to emerging themes, which were manually coded and substantiated with verbatim quotations. Results There was a close fit between the dual theory and participants' clinical thinking processes. This included instant problem framing, consistent with automatic intuitive thinking, focusing on the risk and urgency of the case. Salient features accounting for these choices were recognizable. There was a second reflective phase, leading to the review of initial judgements. Conclusions The proposed model highlights the critical steps in decision making. This allows regular recalibration of knowledge that is most critical at each of these steps. In line with good practice, the model also links the crucial knowledge used in decision making, to value judgments made in relation to the patient. PMID:20367693

  1. Guide to good practices for timely orders to operators

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Timely Orders to Operators, Chapter XV of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing Timely Orders to Operators programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Timely Orders to Operators is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for timely orders to operators to promote safe and efficient operations.

  2. Current good manufacturing practice for positron emission tomography drugs.

    PubMed

    2009-12-10

    The Food and Drug Administration (FDA) is issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The regulations are intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. In this final rule, we are establishing CGMP regulations for approved PET drugs. For investigational and research PET drugs, the final rule states that the requirement to follow CGMP may be met by complying with these regulations or by producing PET drugs in accordance with the United States Pharmacopeia (USP) general chapter on compounding PET radiopharmaceuticals. We are establishing these CGMP requirements for PET drugs under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, we are announcing the availability of a guidance entitled "PET Drugs--Current Good Manufacturing Practice (CGMP)." PMID:20169678

  3. [Good practice for medical surveillance by occupational physicians].

    PubMed

    Roscelli, F; Frigeri, G; Quercia, A; De Rosa, A

    2006-01-01

    Society--employers, workers, trade unions, public--demands the highest standards of professional competence and ethical conduct from occupational physicians. However, defining what exactly constitutes good medical practice and acceptable standards of professional competence and conduct is not so easily done. Good practice in occupational medicine should be aimed not only at improving the effectiveness of preventive action in the strict sense, but also at constantly adopting rigorous methodologies based on evidence and procedures breaking loose from rigid formats, which must be as uniform as possible throughout the country. It's essential, therefore, to develop consensus documents on workers' health surveillance, meeting with approval of occupational health physicians both operating in a free market context or within the framework of public sector health service. PMID:17144422

  4. Emergency management training program: Guide to good practice

    SciTech Connect

    Not Available

    1991-07-01

    The Emergency Management Training Program Guide to Good Practice is a project of the Training Resources and Data Exchange (TRADE) Emergency Management Issues Special Interest Group (EMI SIG). EMI SIG members expressed interest in a resource to assist in development of a comprehensive emergency management training program. This publication provides guidelines, methods, and materials for EMI SIG members to use, assisting in complete and effective emergency management programs. The purposes of the Emergency Management Training Program Guide to Good Practice are: Provide guidance in the development and management of Emergency Management (EM) training programs; Assist EM trainers to incorporate components of the DOE Emergency Management System philosophy of planning, preparedness, readiness assurance, and response into EM training programs; Help EM training managers meet EM training requirements and conditions established by current regulations and policies; Supplement other TRADE EMI SIG documents and complement individual facility training documents. This program is designed for emergency management personnel who are responsible for providing or overseeing EM training but who do not necessarily possess expertise in developing training. It provides good practices from the manager`s point of view on how to produce, administer, and document facility EM training programs in the spirit of the DOE EM system philosophy. Basic guidance is also included for personnel who design, develop, deliver, and/or evaluate EM training programs or parts. This guidance includes key points of EM training programs and identifies other documents that contain useful and/or more detailed training information.

  5. Emergency management training program: Guide to good practice

    SciTech Connect

    Not Available

    1991-07-01

    The Emergency Management Training Program Guide to Good Practice is a project of the Training Resources and Data Exchange (TRADE) Emergency Management Issues Special Interest Group (EMI SIG). EMI SIG members expressed interest in a resource to assist in development of a comprehensive emergency management training program. This publication provides guidelines, methods, and materials for EMI SIG members to use, assisting in complete and effective emergency management programs. The purposes of the Emergency Management Training Program Guide to Good Practice are: Provide guidance in the development and management of Emergency Management (EM) training programs; Assist EM trainers to incorporate components of the DOE Emergency Management System philosophy of planning, preparedness, readiness assurance, and response into EM training programs; Help EM training managers meet EM training requirements and conditions established by current regulations and policies; Supplement other TRADE EMI SIG documents and complement individual facility training documents. This program is designed for emergency management personnel who are responsible for providing or overseeing EM training but who do not necessarily possess expertise in developing training. It provides good practices from the manager's point of view on how to produce, administer, and document facility EM training programs in the spirit of the DOE EM system philosophy. Basic guidance is also included for personnel who design, develop, deliver, and/or evaluate EM training programs or parts. This guidance includes key points of EM training programs and identifies other documents that contain useful and/or more detailed training information.

  6. Defending the four principles approach as a good basis for good medical practice and therefore for good medical ethics.

    PubMed

    Gillon, Raanan

    2015-01-01

    This paper argues that the four prima facie principles-beneficence, non-maleficence, respect for autonomy and justice-afford a good and widely acceptable basis for 'doing good medical ethics'. It confronts objections that the approach is simplistic, incompatible with a virtue-based approach to medicine, that it requires respect for autonomy always to have priority when the principles clash at the expense of clinical obligations to benefit patients and global justice. It agrees that the approach does not provide universalisable methods either for resolving such moral dilemmas arising from conflict between the principles or their derivatives, or universalisable methods for resolving disagreements about the scope of these principles-long acknowledged lacunae but arguably to be found, in practice, with all other approaches to medical ethics. The value of the approach, when properly understood, is to provide a universalisable though prima facie set of moral commitments which all doctors can accept, a basic moral language and a basic moral analytic framework. These can underpin an intercultural 'moral mission statement' for the goals and practice of medicine. PMID:25516950

  7. Computerized Grading of Anatomy Laboratory Practical Examinations

    ERIC Educational Resources Information Center

    Krippendorf, Beth B.; Bolender, David L.; Kolesari, Gary L.

    2008-01-01

    At the Medical College of Wisconsin, a procedure was developed to allow computerized grading and grade reporting of laboratory practical examinations in the Clinical Human Anatomy course. At the start of the course, first year medical students were given four Lists of Structures. On these lists, numbered items were arranged alphabetically; the…

  8. Guide to good practices for on-the-job training

    SciTech Connect

    1998-04-01

    Training programs at DOE facilities should prepare personnel to safely and efficiently operate and maintain the facilities in accordance with DOE requirements. This guide presents good practices for a systematic approach to on-the-job training (OJT) and OJT programs and should be used in conjunction with DOE Training Program Handbook: A Systematic Approach to Training, and with the DOE Handbook entitled Alternative Systematic Approaches to Training to develop performance-based OJT programs. DOE contractors may also use this guide to modify existing OJT programs that do not meet the systematic approach to training (SAT) objectives.

  9. Enterobacteriaceae as indicators of good manufacturing practices in rendering plants.

    PubMed

    van Schothorst, M; Oosterom, J

    1984-01-01

    Finished products and samples from the environment of the production line in rendering plants were checked for Enterobacteriaceae and salmonellae. Improvements in hygiene and measures taken to limit multiplication of microorganisms in the dry area of the production lines resulted in reduction of both numbers of Enterobacteriaceae in environmental samples and frequency of their occurrence in finished products. Simultaneously, there was an equivalent reduction of salmonellae positives in environmental samples and finished products. Consequently, the determination of Enterobacteriaceae can be used as an effective tool to assess the improvements in good manufacturing practices. PMID:6721473

  10. Good manufacturing practices for medicinal products for human use

    PubMed Central

    Gouveia, Bruno G.; Rijo, Patrícia; Gonçalo, Tânia S.; Reis, Catarina P.

    2015-01-01

    At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability. PMID:25883511

  11. Good manufacturing practices for medicinal products for human use.

    PubMed

    Gouveia, Bruno G; Rijo, Patrícia; Gonçalo, Tânia S; Reis, Catarina P

    2015-01-01

    At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability. PMID:25883511

  12. Holding children and young people: defining skills for good practice.

    PubMed

    Page, Andrea; McDonnell, Andrew

    Physical holds are used to help children and young people receive clinical care in situations where their behaviour may limit the ability of nurses and allied professionals to deliver treatment effectively. This article provides an overview of a qualitative study of 11 nurses and allied professionals who were interviewed with semi-structured questions. The major findings suggest there is a lack of clear and agreed terminology and nurses and allied professionals are guessing at how to describe the practice. As a result, there was no discussion or documentation of the practices of holding (whether successful or unsuccessful) within the clinical area. For the last decade, professional opinion was that this is an 'uncontested practice'. It can therefore be questioned whether this practice has moved from being 'uncontested' to 'indifferent'. Nurses and allied professionals need to revive a common definition of 'good' around the actions of holding, which can hopefully lead to holding skills being more clearly defined and evidence-based. PMID:24225549

  13. Good practices in migrant health: the European experience.

    PubMed

    Mladovsky, Philipa; Ingleby, David; McKee, Martin; Rechel, Bernd

    2012-06-01

    Migrants comprise a growing proportion of European populations. Although many are healthy, those who do need healthcare often face barriers and the care they receive may be inappropriate to their needs. This paper summarises good practices identified in a review of health services for migrants in Europe. Governments should ensure that migrants are entitled to health services, that the services are appropriate to their needs and that data systems are in place to monitor utilisation and detect inequities. Health services should adopt a 'whole organisation approach', in which cultural competence is viewed as much as a task for organisations as for individuals. Health workers should take steps to overcome language, social and cultural barriers to care. In each case, existing examples of good practice are provided. At a time when support is growing in some countries for political parties pursuing anti-immigrant agendas and governments in all countries are pursuing austerity policies, there is a greater need than ever for the public health community to ensure that migrants have access to services that are effective and responsive to their needs. PMID:22783777

  14. Validation of good agricultural practices (GAP) on Minnesota vegetable farms.

    PubMed

    Hamilton, Karin E; Umber, Jamie; Hultberg, Annalisa; Tong, Cindy; Schermann, Michele; Diez-Gonzalez, Francisco; Bender, Jeff B

    2015-02-01

    The United States Food and Drug Administration and the Department of Agriculture jointly published the "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables," which is used as a basis for Good Agricultural Practices (GAP) audits. To understand barriers to incorporation of GAP by Minnesota vegetable farmers, a mail survey completed in 2008 was validated with visits to a subset of the farms. This was done to determine the extent to which actual practices matched perceived practices. Two hundred forty-six producers completed the mail survey, and 27 participated in the on-farm survey. Over 75% of the on-farm survey respondents produced vegetables on 10 acres or less and had 10 or fewer employees. Of 14 questions, excellent agreement between on-farm interviews and mail survey responses was observed on two questions, four questions had poor or slight agreement, and eight questions had no agreement. Ninety-two percent of respondents by mail said "they took measures to keep animals and pests out of packing and storage buildings." However, with the on-site visit only 45% met this requirement. Similarly, 81% of respondents by mail said "measures were taken to reduce the risk of wild and/or domestic animals entering into fruit and vegetable growing areas." With direct observation, 70% of farms actually had taken measures to keep animals out of the growing areas. Additional, on-farm assessments were done regarding employee hygiene, training, presence of animals, water sources, and composting practices. This validation study demonstrated the challenge of creating nonleading and concise questions that are not open to broad interpretation from the respondents. If mail surveys are used to assess GAP, they should include open-ended questions and ranking systems to better assess farm practices. To provide the most accurate survey data for educational purposes or GAP audits, on-farm visits are recommended. PMID:25564923

  15. 75 FR 16345 - Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 10 (formerly Docket No. 1999N-4783) Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA)...

  16. A Good Death? Report of the Second Newcastle Meeting on Laboratory Animal Euthanasia.

    PubMed

    Hawkins, Penny; Prescott, Mark J; Carbone, Larry; Dennison, Ngaire; Johnson, Craig; Makowska, I Joanna; Marquardt, Nicole; Readman, Gareth; Weary, Daniel M; Golledge, Huw D R

    2016-01-01

    Millions of laboratory animals are killed each year worldwide. There is an ethical, and in many countries also a legal, imperative to ensure those deaths cause minimal suffering. However, there is a lack of consensus regarding what methods of killing are humane for many species and stages of development. In 2013, an international group of researchers and stakeholders met at Newcastle University, United Kingdom to discuss the latest research and which methods could currently be considered most humane for the most commonly used laboratory species (mice, rats and zebrafish). They also discussed factors to consider when making decisions about appropriate techniques for particular species and projects, and priorities for further research. This report summarises the research findings and discussions, with recommendations to help inform good practice for humane killing. PMID:27563926

  17. 76 FR 47593 - Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-05

    ... a guidance for small business entities entitled ``PET Drugs--Current Good Manufacturing Practice... entitled ``PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.'' This... Manufacturing Practice for Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug...

  18. How successful is the dual diagnosis good practice guide?

    PubMed

    Laker, Caroline

    Evidence from the US shows that integrated treatment programmes for dually diagnosed patients are more successful than parallel treatment programmes. In the UK the Dual Diagnosis Good Practice Guide (DDGPG, 2002a), advocates a move towards an integrated system of care delivery. However, the paucity of evidence in the UK and the entrenched nature of the established mental health and addictions services means that current policy is derived from limited information and is struggling to address the process of change. By definition, dual diagnosis is a complex interaction between a range of mental health and substance misuse problems leading to difficulties in allocating appropriate skill mixes to teams. Ethical and legal issues in the mental health services cause conflict with the treatment concepts for substance misuse. The advent of the DDGPG is positive, but there is a clear need for further work in this area. PMID:16936621

  19. Good Practice Guide Waste Minimization/Pollution Prevention

    SciTech Connect

    J Dorsey

    1999-10-14

    This Good Practice Guide provides tools, information, and examples for promoting the implementation of pollution prevention during the design phases of U.S. Department of Energy (DOE) projects. It is one of several Guides for implementing DOE Order 430.1, Life-cycle Asset Management. DOE Order 430.1 provides requirements for DOE, in partnership with its contractors, to plan, acquire, operate, maintain, and dispose of physical assets. The goals of designing for pollution prevention are to minimize raw material consumption, energy consumption, waste generation, health and safety impacts, and ecological degradation over the entire life of the facility (EPA 1993a). Users of this Guide will learn to translate national policy and regulatory requirements for pollution prevention into action at the project level. The Guide was written to be applicable to all DOE projects, regardless of project size or design phase. Users are expected to interpret the Guide for their individual project's circumstances, applying a graded approach so that the effort is consistent with the anticipated waste generation and resource consumption of the physical asset. This Guide employs a combination of pollution prevention opportunity assessment (PPOA) methods and design for environment (DfE) philosophies. The PPOA process was primarily developed for existing products, processes, and facilities. The PPOA process has been modified in this Guide to address the circumstances of the DOE design process as delineated in DOE Order 430.1 and its associated Good Practice Guides. This modified form of the PPOA is termed the Pollution Prevention Design Assessment (P2DA). Information on current nationwide methods and successes in designing for the environment also have been reviewed and are integrated into this guidance.

  20. Do quality indicators for general practice teaching practices predict good outcomes for students?

    PubMed

    Bartlett, Maggie; Potts, Jessica; McKinley, Bob

    2016-07-01

    Keele medical students spend 113 days in general practices over our five-year programme. We collect practice data thought to indicate good quality teaching. We explored the relationships between these data and two outcomes for students; Objective Structured Clinical Examination (OSCE) scores and feedback regarding the placements. Though both are surrogate markers of good teaching, they are widely used. We collated practice and outcome data for one academic year. Two separate statistical analyses were carried out: (1) to determine how much of the variation seen in the OSCE scores was due to the effect of the practice and how much to the individual student. (2) to identify practice characteristics with a relationship to student feedback scores. (1) OSCE performance: 268 students in 90 practices: six quality indicators independently influenced the OSCE score, though without linear relationships and not to statistical significance. (2) Student satisfaction: 144 students in 69 practices: student feedback scores are not influenced by practice characteristics. The relationships between the quality indicators we collect for practices and outcomes for students are not clear. It may be that neither the quality indicators nor the outcome measures are reliable enough to inform decisions about practices' suitability for teaching. PMID:27117344

  1. A European code of good practice for hyperbaric oxygen therapy.

    PubMed

    Kot, Jacek; Desola, Jordi; Simao, Antonio Gata; Gough-Allen, Roly; Houman, Robert; Meliet, Jean-Luis; Galland, Francois; Mortensen, Christian; Mueller, Peter H J; Sippinen, Seppo

    2004-01-01

    In 2001 the Working Group (WG) "Safety" was created within the European COST Action B14 "Hyperbaric Oxygen Therapy" with the main objectives to elaborate recommendations of good practice for hyperbaric medicine and to follow the European normalisation process of hyperbaric chambers. During three years of preparation of the European Code of Good Practice (ECGP) for HBO, the relevant documents concerning safety in hyperbaric chambers from each European country have been revised. The initial document drew on the BHA "Health and Safety for Therapeutic Hyperbaric Facilities: A Code-of Practice" (2000), and later on it was modified using national regulations and standards (from Belgium, Finland, France, Germany, Greece, Italy, Portugal, and Spain), as well as European Norms and existing experience from experts of hyperbaric centres, committees, professional and scientific associations. The ECGP for HBO consists of chapters dedicated to staffing (including responsibilities, competencies and education, minimum team during hyperbaric sessions, fitness and health surveillance), equipment, gas supply, risk management and procedures (including standard and emergency operating procedures, maintenance, record keeping, and patient safety). It also includes ECHM Educational and Training Standards for the Staff of Hyperbaric Centres (1997), ECHM Recommendation for Safety in Multiplace Medical Hyperbaric Chambers (1998), as well as COST B14 Working Group "Technical Aspects" Final Report (2001) including a risk analysis conducted specifically for therapeutic hyperbaric facilities. Many efforts have been spent to make the ECGP for HBO compatible with the new project of the European Norm prEN 14931 "Pressure vessels for human occupancy (PVHO)--Multiplace pressure chamber system for hyperbaric therapy--Performance, safety requirements and testing", which has been prepared at the same time by the CEN/BT/TF 127. Both groups (CEN/BT/TF 127 and COST B14 WG "Safety") cooperated extensively

  2. [Good Practice of Clinical Physiology Examination for Patient Safety with a Team-Based Approach: Quality Practice in Ultrasonographic Examination].

    PubMed

    Asai, Satomi; Miyachi, Hayato

    2015-07-01

    For the safety of patient care, a team-based approach has been advocated as an effective measure. In clinical physiology examination, we have been making efforts to promote good practice for patient safety based on such an approach in Tokai University Hospital, as represented by quality practice in ultrasonographic examination. The entire process of ultrasonographic examination can be divided into three parts: pre-examination, examination, and post-examination processes. In each process of the examination, specific quality issues must be considered, eventually ensuring the quality and safety of patient care. A laboratory physician is responsible for not only quality assurance of examination, diagnosis, and reporting, but also patient safety. A laboratory physician can play a key role in all aspects of patient safety related to each process of the examination by taking a leadership role in the team-based approach. PMID:26591436

  3. Good housekeeping: Safety and order in the scientific laboratory

    SciTech Connect

    Sims, B. H.

    2002-01-01

    Laboratory safety might not seem, at first, to be very profoundly related to scientific knowledge. Of course safety is a relatively trivial issue in many scientific settings, especially in comparison to the kind of safety concerns found, say, at a construction site or a chemical plant. However, as scientific work has come to involve more exotic chemicals, biological organisms, and forms of radiation, and generally become more industrial in character, safety has become more of a concern. This has occurred alongside a general expansion of government regulation of workplace safety during the 20thc entury, and a recent trend toward extending work lace safety efforts to new kinds of work, including administrative and professional tasks. As a result of these trends, scientists find that they are increasingly being held responsible for following safety regulations in their re{approx}earc

  4. [Interpretation of Guidelines on Good Pharmacovigilance Practices for European Union].

    PubMed

    Xie, Yan-Ming; Tian, Feng

    2013-09-01

    Due to the limitations of pre-authorization clinical trials, the safety information obtained from them is relatively limited. Therefore, it is very necessary to carry out pharmacovigilance activities on drugs post-marketing. In order to promote the specific implementation of the new pharmacovigilance regulations, the European medicines agency (EMA) developed the Guideline on Good Pharmacovigilance Practices (GVP), as the new criteria for pharmacovigilance in the European Union (EU). Compared with the previously published, Guidelines on Pharmacovigilance for Medicinal Products for Human Use (2007), the GVP proposed more comprehensive and systematic provisions of pharmacovigilance systems, quality control systems, judgements, pharmacovigilance inspections and audits. In addition, it set more specific and comprehensive requirements on risk management systems, the management and reporting of adverse reactions to medicinal products, periodic safety update reports, post-authorization safety studies, signal management, and so on. Interpreting the basic principles, working mechanisms, key technologies and methods of the GVP provides a useful reference for us to carry out pharmacovigilance (especially regarding safety monitoring of parenterally administered Chinese medicine). PMID:24471312

  5. Preparation of intravenous cholesterol tracer using current good manufacturing practices.

    PubMed

    Lin, Xiaobo; Ma, Lina; Racette, Susan B; Swaney, William P; Ostlund, Richard E

    2015-12-01

    Studies of human reverse cholesterol transport require intravenous infusion of cholesterol tracers. Because insoluble lipids may pose risk and because it is desirable to have consistent doses of defined composition available over many months, we investigated the manufacture of cholesterol tracer under current good manufacturing practice (CGMP) conditions appropriate for phase 1 investigation. Cholesterol tracer was prepared by sterile admixture of unlabeled cholesterol or cholesterol-d7 in ethanol with 20% Intralipid(®). The resulting material was filtered through a 1.2 micron particulate filter, stored at 4°C, and tested at time 0, 1.5, 3, 6, and 9 months for sterility, pyrogenicity, autoxidation, and particle size and aggregation. The limiting factor for stability was a rise in thiobarbituric acid-reacting substances of 9.6-fold over 9 months (P < 0.01). The emulsion was stable with the Z-average intensity-weighted mean droplet diameter remaining at 60 nm over 23 months. The zeta potential (a measure of negative surface charge protecting from aggregation) was unchanged at -36.2. Rapid cholesterol pool size was 25.3 ± 1.3 g. Intravenous cholesterol tracer was stable at 4°C for 9 months postproduction. CGMP manufacturing methods can be achieved in the academic setting and need to be considered for critical components of future metabolic studies. PMID:26416797

  6. [Procedural guidelines. Good tissue practice for cornea banks].

    PubMed

    Schroeter, J; Maier, P; Bednarz, J; Blüthner, K; Quenzel, M; Pruss, A; Reinhard, T

    2009-03-01

    A cornea bank must have an organizational structure in which responsibility and authority to issue directives are clearly defined. It must also use a documented quality management system on the basis of good practice procedures which is maintained to the current standards. The personnel of a cornea bank must be present in sufficient numbers and be suitably qualified. A cornea bank must be in possession of appropriate facilities which are suitable for the main purpose of conservation of donor corneas. All equipment must be designed and maintained corresponding to the intended purpose. Deviations from the stipulated quality and safety standards must give rise to documented investigations which include decisions on options for correctional and preventive measures. Acquisition of donors and tissue sampling must be strictly controlled and documented. This also applies to entry of donor tissue in the cornea bank. During conservation a microscopic examination of the endothelial cell layer must be carried out at least once. Measures must be taken to keep the risk of contamination as low as possible. Donor corneal tissue can only be released if defined criteria are fulfilled. Any suspicion of severe undesired reactions and events for the recipient of a corneal transplant must be registered with the authorities. The activities of a cornea bank must maintain and adapt the state-of-the-art with respect to scientific progress. PMID:19263054

  7. 78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... HUMAN SERVICES Food and Drug Administration Device Good Manufacturing Practice Advisory Committee... meeting will be open to the public. Name of Committee: Device Good Manufacturing Practice Advisory... effects of extreme weather and natural disasters on medical device manufacturing chain processes...

  8. Publishing integrity and good practices in editing in biomedicine.

    PubMed

    Polenakovic, Momir; Gucev, Zoran

    2014-01-01

    The Macedonian Academy of Sciences and Arts (MASA), held a scientific workshop for journal editors in biomedicine: "Publishing integrity and good practices in editing in biomedicine" on April 25, 2014 in MASA, Skopje. The meeting looked into old problems and new situations in editing and publishing, with emphasis on the situation in developing countries. This global knowledge-based society is founded on the results obtained from scientific research. The data from basic research in developed countries contribute in a quite substantial manner to the newly added economic value. One of the main reasons for underdevelopment in South Eastern Europe (SEE) is certainly a low or non-existent contribution of scientific research in the newly added economic value. This has largely to do with the perception of the political elites which simply lack the insight on the crucial importance of science in development. In the long term this leads to societies in which there are distortions in the understanding of the most basic values. Academic publishing has experienced tremendous growth: so far there are at least 50 million scientific articles. Interestingly, publishing in developing countries has experienced a rate of growth higher than in developed countries. However, this is not the case with the Balkan countries. The meeting looked at some old and some newly emerging problems in editing and publishing. First, the high cost for universities and researchers to purchase journals adversely affects both publishing and editing. In developing countries the high cost of purchasing scientific literature is an almost insurmountable problem in spite of the fact that some publishing companies offer discounted fees. Open access journals in South Eastern European (SEE) countries are hardly achievable as this also incurs costs that have to be covered in some way or other. The peer review process has the fundamental difficulty that reviewers are in the situation of a Procrustean bed, tending to

  9. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What is current good manufacturing practice for... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET...

  10. 21 CFR 210.1 - Status of current good manufacturing practice regulations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Status of current good manufacturing practice... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.1 Status of current good manufacturing practice...

  11. 21 CFR 210.1 - Status of current good manufacturing practice regulations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Status of current good manufacturing practice... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.1 Status of current good manufacturing practice...

  12. 21 CFR 210.1 - Status of current good manufacturing practice regulations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Status of current good manufacturing practice... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.1 Status of current good manufacturing practice...

  13. 21 CFR 210.1 - Status of current good manufacturing practice regulations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Status of current good manufacturing practice... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.1 Status of current good manufacturing practice...

  14. 21 CFR 210.1 - Status of current good manufacturing practice regulations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Status of current good manufacturing practice... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.1 Status of current good manufacturing practice...

  15. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false What is current good manufacturing practice for... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET...

  16. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What is current good manufacturing practice for... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS (Eff. 12-12-2011) General Provisions § 212.2 What is current good manufacturing practice...

  17. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false What is current good manufacturing practice for... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET...

  18. Addressing the Challenge of Diversity in the Graduate Ranks: Good Practices Yield Good Outcomes

    ERIC Educational Resources Information Center

    Thompson, Nancy L.; Campbell, Andrew G.

    2013-01-01

    In this paper, we examine the impact of implementing three systemic practices on the diversity and institutional culture in biomedical and public health PhD training at Brown University. We hypothesized that these practices, designed as part of the National Institutes of Health-funded Initiative to Maximize Student Development (IMSD) program in…

  19. Educating for Good Work: From Research to Practice

    ERIC Educational Resources Information Center

    Mucinskas, Daniel; Gardner, Howard

    2013-01-01

    Launched in 1995, the GoodWork Project is a long-term, multi-site effort to understand the nature of good work across the professional landscape and to promote its achievement by relevant groups of students and professionals. In this essay, the authors review the goals and methods of the initial research project and its most salient findings. They…

  20. Addressing the Challenge of Diversity in the Graduate Ranks: Good Practices Yield Good Outcomes

    PubMed Central

    Thompson, Nancy L.; Campbell, Andrew G.

    2013-01-01

    In this paper, we examine the impact of implementing three systemic practices on the diversity and institutional culture in biomedical and public health PhD training at Brown University. We hypothesized that these practices, designed as part of the National Institutes of Health–funded Initiative to Maximize Student Development (IMSD) program in the Division of Biology and Medicine, would have a positive effect on underrepresented minority (URM) recruitment and retention and objective measures of student success. These practices include: 1) develop strategic partnerships with selected undergraduate institutions; 2) provide a personalized education program of student support and skill-based modules to supplement discipline-based course work; and 3) transform institutional culture by engaging faculty in supporting diversity-related goals and practices. Data comparing URM numbers and key academic milestones before and after implementation of IMSD practices support the initial hypothesis and effectiveness of these practices at Brown. Program components are broadly applicable as best practices for others seeking to improve URM recruitment and achievements of graduate students traditionally underrepresented in the sciences. PMID:23463225

  1. Testing and Assessment: An Employer's Guide to Good Practices.

    ERIC Educational Resources Information Center

    Saad, Syed; Carter, Gary W.; Rothenberg, Mark; Israelson, Enid

    This guide was developed to help managers and human resource (HR) professionals use assessment practices that are the right choices for reaching their organizations' HR goals. It provides information about assessment practices so that managers and HR professionals can evaluate and select assessment tools and procedures that maximize chances for…

  2. Good practices in collecting umbilical cord and placental blood 1

    PubMed Central

    Lopes, Lauren Auer; Bernardino, Elizabeth; Crozeta, Karla; Guimarães, Paulo Ricardo Bittencourt

    2016-01-01

    Abstract Objective: to identify the factors related to the quality of umbilical cord and placental blood specimens, and define best practices for their collection in a government bank of umbilical cord and placental blood. Method: this was a descriptive study, quantitative approach, performed at a government umbilical cord and placental blood bank, in two steps: 1) verification of the obstetric, neonatal and operational factors, using a specific tool for gathering data as non-participant observers; 2) definition of best practices by grouping non-conformities observed before, during and after blood collection. The data was analyzed using descriptive statistics and the following statistical software: Statistica(r) and R(r). Results: while there was a correlation with obstetrical and neonatal factors, there was a larger correlation with operational factors, resulting in the need to adjust the professional practices of the nursing staff and obstetrical team involved in collecting this type of blood. Based on these non-conformities we defined best practices for nurses before, during and after blood collection. Conclusion: the best practices defined in this study are an important management tool for the work of nurses in obtaining blood specimens of high cell quality. PMID:27556876

  3. Collaborative Practice: The Basis of Good Educational Work

    ERIC Educational Resources Information Center

    James, Chris

    2007-01-01

    It is notoriously difficult to classify occupations as professions and to define professional work. Numerous authors have provided criteria for categorising occupations as professions but the judgement still remains a difficult one. Freidson (1991) is clear that professional work is Good Work. It has a moral purpose and arguably that sense of…

  4. Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation.

    PubMed

    Marshall, S F; Burghaus, R; Cosson, V; Cheung, S Y A; Chenel, M; DellaPasqua, O; Frey, N; Hamrén, B; Harnisch, L; Ivanow, F; Kerbusch, T; Lippert, J; Milligan, P A; Rohou, S; Staab, A; Steimer, J L; Tornøe, C; Visser, S A G

    2016-03-01

    This document was developed to enable greater consistency in the practice, application, and documentation of Model-Informed Drug Discovery and Development (MID3) across the pharmaceutical industry. A collection of "good practice" recommendations are assembled here in order to minimize the heterogeneity in both the quality and content of MID3 implementation and documentation. The three major objectives of this white paper are to: i) inform company decision makers how the strategic integration of MID3 can benefit R&D efficiency; ii) provide MID3 analysts with sufficient material to enhance the planning, rigor, and consistency of the application of MID3; and iii) provide regulatory authorities with substrate to develop MID3 related and/or MID3 enabled guidelines. PMID:27069774

  5. [Characteristics and challenges of rheumatology-specific laboratories in practice].

    PubMed

    von Hinüber, U

    2016-05-01

    In Germany rheumatological laboratory investigations are increasingly being carried out by rheumatologists in private practice. The professional and economic value is shown in association with the historical development of laboratory medicine and the current discussion on vocational politics. PMID:27048478

  6. Budget Theory and Budget Practice: How Good the Fit?

    ERIC Educational Resources Information Center

    Rubin, Irene S.

    1990-01-01

    Describes the past and present and projects the future of the relationship between theory and practice for normative and descriptive budget theory. Considers the present and future of normative theory gloomy because budgeting has changed and traditional reform ideas have outlived their usefulness. States that descriptive theory has improved and…

  7. Educating Global Citizens: A Good "Idea" or an Organisational Practice?

    ERIC Educational Resources Information Center

    Lilley, Kathleen; Barker, Michelle; Harris, Neil

    2015-01-01

    Higher education emphasises training and skills for employment, yet while the "idea" of educating global citizens appears in university discourse, there is limited evidence demonstrating how the "idea" of the global citizen translates into practice. Recent research emphasises a desire for graduates to be local and global…

  8. How to improve the performance of a good medical practice team: twelve techniques.

    PubMed

    Hills, Laura

    2013-01-01

    It is incredibly easy to ignore the medical practice team that is doing a good job. However, when we allow good performers to continue as they are, they probably won't improve. Their performance may even worsen. This is unfortunate because with a little bit of effort and support, good performers can often learn to excel. This article offers 12 techniques medical practice managers can use to bring their team members from good performance to excellent. It describes how to use goal-setting, work assignments, modeling, confidence building, team retreats, rewards, incentives, and reinforcement to ratchet up a good medical practice team's performance. This article also identifies the signs of medical employee mediocrity. It describes why setting higher expectations of your medical practice employees will ultimately improve their performance. Finally, this article suggests 10 practical and affordable strategies that medical practice managers can use to reinforce excellent performance in their good employees. PMID:23866656

  9. Clinical audit: shining a light on good practice.

    PubMed

    Grainger, Angela

    2010-07-01

    Healthcare organisations undertake quality assurance to produce safe and effective patient care systems. Statutory quality assurance requirements are met through external reviews, monitoring and inspection processes, and each NHS trust must produce a corporate annual quality account. However, this can result in approaching audits as if they are 'tick-box activities'. This article discusses how organisations can avoid this trap by applying audit results to practice. PMID:20681403

  10. 'Dry Laboratories' in Science Education; Computer-Based Practical Work.

    ERIC Educational Resources Information Center

    Kirschner, Paul; Huisman, Willibrord

    1998-01-01

    Identifies the problems associated with the use of dry laboratories in science education, presents design considerations for the use of such practicals in science education, and presents examples of innovative nontraditional practicals. Contains 23 references. (DDR)

  11. Mini-Special Issue: Taking Practical Work Beyond the Laboratory.

    ERIC Educational Resources Information Center

    Hodson, Derek

    1998-01-01

    Reviews the traditional definition of practical work in science, offers a different definition of it, and points out that practical work is not always laboratory based. Discusses the logistics of coordinating fieldwork. Contains 17 references. (DDR)

  12. A Good Name and Great Riches: Rebranding Solid State Physics for the National Laboratories

    NASA Astrophysics Data System (ADS)

    Martin, Joseph

    2012-03-01

    In 1943 Oliver Buckley, lamenting the inadequacy of term ``physics'' to evoke what physicists did, quoted the proverb, ``A good name is rather to be chosen than great riches.'' Some forty years later, solid state physicists confronted similar discontent with their name, precipitating the rise of the appellation ``condensed matter physics.'' Ostensibly a rebranding of a well-established field, the change signaled deeper conceptual and institutional realignment. Whereas ``solid state'' emerged in the 1940s in the service of institutional aims, ``condensed matter'' more accurately captured a distinct set of theoretical and experimental approaches. Reimagining the field around core conceptual approaches set condensed matter apart from the inchoate field of materials science, which subsumed a growing proportion of solid state funding and personnel through the 1980s. Federally funded research installations were the source of ``great riches'' for scientific research. The DOE National Laboratory System and the DARPA network of Interdisciplinary Laboratories, given their responsiveness to shifts in national funding priorities, provide a sensitive historical instrument through which to trace the transition from solid state to condensed matter. The reorganization of solid state in response to the evolution of national priorities and funding practices precipitated a sharpening of the field's intellectual mission. At the same time, it reflected the difficulties solid state faced articulating its intellectual--as opposed to technological--merit. The proverb continues, `` and loving favor rather than silver and gold.'' The adoption of a name that emphasized intellectual cohesion and associated social esteem exposed the growing tension between technology-oriented national funding goals for materials research and condensed matter physics' ascendant intellectual identity.

  13. The Good, the Bad, and the Unknown: Quality of Clinical Laboratories in Kampala, Uganda

    PubMed Central

    Elbireer, Ali M.; Jackson, J. Brooks; Sendagire, Hakim; Opio, Alex; Bagenda, Danstan; Amukele, Timothy K.

    2013-01-01

    Background Clinical laboratories are crucial in addressing the high rates of communicable and non-communicable diseases seen in sub-Saharan Africa (SSA). However, the most basic information, such as the number and quality of clinical laboratories in SSA, is not available. The objective of this study was to create a practical method for obtaining this information in SSA towns and cities using an initial survey in Kampala, Uganda. Methods Kampala city was divided into 5 partially-overlapping regions. Each region was assigned to 2–3 surveyors who identified and surveyed laboratories in their respective regions; in person and on foot. A modified version of the World Health Organization - African Region (WHO/AFRO) Laboratory Strengthening Checklist was used to obtain baseline measures of quality for all clinical laboratories within Kampala city. The surveyors also measured other attributes of each laboratory, such as their affiliation (government, private etc), designation (national hospital, district hospital, standalone etc), staff numbers, and type of staff. Results The survey team identified and surveyed 954 laboratories in Kampala city. 96% of laboratories were private. Only 45 (5%) of the laboratories met or surpassed the lowest quality standards defined by the WHO/AFRO-derived laboratory strengthening tool (1-star). These 45 higher-quality laboratories were, on average, larger and had a higher number of laboratory-specific staff (technologists, phlebotomists etc) than the other 909 laboratories. 688 (72%) of the 954 laboratories were not registered with the Ministry of Health (MoH). Conclusions This comprehensive evaluation of the number, scope, and quality of clinical laboratories in Kampala is the first published survey of its kind in sub-Saharan Africa. The survey findings demonstrated that laboratories in Kampala that had qualified personnel and those that had higher testing volumes, tended to be of higher-quality. PMID:23737993

  14. Good Signal Detection Practices: Evidence from IMI PROTECT.

    PubMed

    Wisniewski, Antoni F Z; Bate, Andrew; Bousquet, Cedric; Brueckner, Andreas; Candore, Gianmario; Juhlin, Kristina; Macia-Martinez, Miguel A; Manlik, Katrin; Quarcoo, Naashika; Seabroke, Suzie; Slattery, Jim; Southworth, Harry; Thakrar, Bharat; Tregunno, Phil; Van Holle, Lionel; Kayser, Michael; Norén, G Niklas

    2016-06-01

    Over a period of 5 years, the Innovative Medicines Initiative PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) project has addressed key research questions relevant to the science of safety signal detection. The results of studies conducted into quantitative signal detection in spontaneous reporting, clinical trial and electronic health records databases are summarised and 39 recommendations have been formulated, many based on comparative analyses across a range of databases (e.g. regulatory, pharmaceutical company). The recommendations point to pragmatic steps that those working in the pharmacovigilance community can take to improve signal detection practices, whether in a national or international agency or in a pharmaceutical company setting. PROTECT has also pointed to areas of potentially fruitful future research and some areas where further effort is likely to yield less. PMID:26951233

  15. In search of the good: narrative reasoning in clinical practice.

    PubMed

    Mattingly, C

    1998-09-01

    Based on ethnographic work among North American occupational therapists, I compare two forms of everyday clinical talk. One, "chart talk," conforms to normative conceptions of clinical rationality. The second, storytelling, permeates clinical discussions but has no formal status as a vehicle for clinical reasoning. I argue that both modes of discourse provide avenues for reasoning about clinical problems. However, these discourses construct very different clinical objects and different phenomena to reason about. Further, the clinical problems created through storytelling point toward a more radically distinct conception of rationality than the one underlying biomedicine as it is formally conceived. Clinical storytelling is more usefully understood as a mode of Aristotle's "practical rationality" than the technical rationality of modern (enlightenment) conceptions of reasoning. PMID:9746895

  16. Good practice for conducting and reporting MEG research

    PubMed Central

    Gross, Joachim; Baillet, Sylvain; Barnes, Gareth R.; Henson, Richard N.; Hillebrand, Arjan; Jensen, Ole; Jerbi, Karim; Litvak, Vladimir; Maess, Burkhard; Oostenveld, Robert; Parkkonen, Lauri; Taylor, Jason R.; van Wassenhove, Virginie; Wibral, Michael; Schoffelen, Jan-Mathijs

    2013-01-01

    Magnetoencephalographic (MEG) recordings are a rich source of information about the neural dynamics underlying cognitive processes in the brain, with excellent temporal and good spatial resolution. In recent years there have been considerable advances in MEG hardware developments and methods. Sophisticated analysis techniques are now routinely applied and continuously improved, leading to fascinating insights into the intricate dynamics of neural processes. However, the rapidly increasing level of complexity of the different steps in a MEG study make it difficult for novices, and sometimes even for experts, to stay aware of possible limitations and caveats. Furthermore, the complexity of MEG data acquisition and data analysis requires special attention when describing MEG studies in publications, in order to facilitate interpretation and reproduction of the results. This manuscript aims at making recommendations for a number of important data acquisition and data analysis steps and suggests details that should be specified in manuscripts reporting MEG studies. These recommendations will hopefully serve as guidelines that help to strengthen the position of the MEG research community within the field of neuroscience, and may foster discussion in order to further enhance the quality and impact of MEG research. PMID:23046981

  17. Online Assessment of Learning and Engagement in University Laboratory Practicals

    ERIC Educational Resources Information Center

    Whitworth, David E.; Wright, Kate

    2015-01-01

    In science education, laboratory practicals are frequently assessed through submission of a report. A large increase in student numbers necessitated us adapting a traditional practical report into an online test with automated marking. The assessment was designed to retain positive features of the traditional laboratory report but with added…

  18. A Process-Oriented Laboratory Practical Exam.

    ERIC Educational Resources Information Center

    Chu, Janet Pattee; Phillips, V. Duzerah

    1983-01-01

    Fifteen stations are used for a laboratory examination which focuses on evaluation of laboratory techniques, skills, procedures, and information management. Examples of several stations (with related questions) are provided. Areas measured include bacterial and cellular culturing, staining, and transferring procedures, genetics…

  19. Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation

    PubMed Central

    Burghaus, R; Cosson, V; Cheung, SYA; Chenel, M; DellaPasqua, O; Frey, N; Hamrén, B; Harnisch, L; Ivanow, F; Kerbusch, T; Lippert, J; Milligan, PA; Rohou, S; Staab, A; Steimer, JL; Tornøe, C; Visser, SAG

    2016-01-01

    This document was developed to enable greater consistency in the practice, application, and documentation of Model‐Informed Drug Discovery and Development (MID3) across the pharmaceutical industry. A collection of “good practice” recommendations are assembled here in order to minimize the heterogeneity in both the quality and content of MID3 implementation and documentation. The three major objectives of this white paper are to: i) inform company decision makers how the strategic integration of MID3 can benefit R&D efficiency; ii) provide MID3 analysts with sufficient material to enhance the planning, rigor, and consistency of the application of MID3; and iii) provide regulatory authorities with substrate to develop MID3 related and/or MID3 enabled guidelines. PMID:27069774

  20. Overcoming the effects of acute stress through good teamwork practices

    SciTech Connect

    Harrington, D.K. ); Gaddy, C.D. )

    1992-01-01

    Two recent industry studies have taken a look at operators in stressful situations. In the context of severe-accident management, Mumaw et al. discussed four approaches to training operators for severe accidents: (1) training for knowledge or procedural skills; (2) training decision makers about goals and plans; (3) training to avoid cognitive biases; and (4) training within a realistic setting. These four approaches address directly the cognitive skills important for decision making. These types of training can also address indirectly the effects of stress on performance. First, effects of stress on decision making, such as reduced working memory, can be addressed by training cognitive skills. Second, exposure to realistically stressful situations can reduce the novelty and uncertainty, which is a primary cause of stress reactions. In a second study reported by Desaulniers, the stress of requalification exams was the focus. Desaulniers concluded that repeated changes in the exam process, inconsistency in interpretation of examiner guidelines, and some content and grading practices resulted in undue stress for the operators. The US Nuclear Regulatory Commission staff actions to remedy these sources of undue stress were described.

  1. De praeceptis ferendis: good practice in multi-model ensembles

    NASA Astrophysics Data System (ADS)

    Kioutsioukis, I.; Galmarini, S.

    2014-06-01

    Ensembles of air quality models have been formally and empirically shown to outperform single models in many cases. Evidence suggests that ensemble error is reduced when the members form a diverse and accurate ensemble. Diversity and accuracy are hence two factors that should be taken care of while designing ensembles in order for them to provide better predictions. There exists a trade-off between diversity and accuracy for which one cannot be gained without expenses of the other. Theoretical aspects like the bias-variance-covariance decomposition and the accuracy-diversity decomposition are linked together and support the importance of creating ensemble that incorporates both the elements. Hence, the common practice of unconditional averaging of models without prior manipulation limits the advantages of ensemble averaging. We demonstrate the importance of ensemble accuracy and diversity through an inter-comparison of ensemble products for which a sound mathematical framework exists, and provide specific recommendations for model selection and weighting for multi model ensembles. To this end we have devised statistical tools that can be used for diagnostic evaluation of ensemble modelling products, complementing existing operational methods.

  2. Think INN, prescribe INN, dispense INN: good professional practice.

    PubMed

    2000-12-01

    (1) International nonproprietary names (INN) for drugs were invented about fifty years ago, under the aegis of the World Health Organisation, to provide a common language for health professionals and patients worldwide. (2) No country forbids INN prescriptions. Some countries actively recommend using INNs. (3) INN prescription empowers prescribers and pharmacists in their choice of treatment. (4) The choice between a prescription based on the INN or the brand name will depend on the type of treatment (short term or chronic), the nature of the drug (especially its therapeutic margin) and any specific risks related to the patient (age, disease condition, allergy, and adherence). (5) A pharmacist's decision to dispense a brand name drug from an INN prescription must be based on usual dispensing precautions. (6) Adopting INN prescribing means having to reflect on one's knowledge of drugs, and to challenge the quality of one's initial and continuing education in pharmacology and therapeutics. The INN system is a means of improving prescribing and dispensing practices: it involves paying more attention to the patient, explaining the treatment in greater detail, and respecting his/her choice. PMID:11475502

  3. Investigating School-Wide Antecedents of Good Practice Dissemination from Individual Subject Projects

    ERIC Educational Resources Information Center

    Christophersen, Knut-Andreas; Elstad, Eyvind; Turmo, Are

    2012-01-01

    Good practice dissemination is an unsolved problem in education. This article describes how clear and "soft" leadership and perceptions of social and economic exchange operate in the bottom-up processes of school reforms and examines the relative impact of these factors on school-wide good practice dissemination and discusses how leadership…

  4. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be...

  5. The Conditional Nature of High Impact/Good Practices on Student Learning Outcomes

    ERIC Educational Resources Information Center

    Seifert, Tricia A.; Gillig, Benjamin; Hanson, Jana M.; Pascarella, Ernest T.; Blaich, Charles F.

    2014-01-01

    Using a multi-institutional sample of undergraduate students, this study found that the relationships between engaging in high impact/good practices and liberal arts outcomes differ based on students' precollege and background characteristics. Findings suggest that high impact/good practices are not a panacea and require a greater degree of…

  6. Ten good reasons to practice ultrasound in critical care.

    PubMed

    Lichtenstein, Daniel; van Hooland, Simon; Elbers, Paul; Malbrain, Manu L N G

    2014-01-01

    combination with lung ultrasound, with the appearance of B-lines considered to be the endpoint for fluid therapy. An advantage of lung ultrasound is that the patient is not exposed to radiation, and so the LUCI-FLR project (LUCI favouring limitation of radiation) can be unfolded in trauma patients. Although it has been practiced for 25 years, critical care ultrasound is a relatively young but expanding discipline and can be seen as the stethoscope of the modern intensivist. In this review, the usefulness and advantages of ultrasound in the critical care setting are discussed in ten points. The emphasis is on a holistic approach, with a central role for lung ultrasound. PMID:25432552

  7. Modeling good research practices--overview: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-1.

    PubMed

    Caro, J Jaime; Briggs, Andrew H; Siebert, Uwe; Kuntz, Karen M

    2012-01-01

    Models-mathematical frameworks that facilitate estimation of the consequences of health care decisions-have become essential tools for health technology assessment. Evolution of the methods since the first ISPOR modeling task force reported in 2003 has led to a new task force, jointly convened with the Society for Medical Decision Making, and this series of seven papers presents the updated recommendations for best practices in conceptualizing models; implementing state-transition approaches, discrete event simulations, or dynamic transmission models; dealing with uncertainty; and validating and reporting models transparently. This overview introduces the work of the task force, provides all the recommendations, and discusses some quandaries that require further elucidation. The audience for these papers includes those who build models, stakeholders who utilize their results, and, indeed, anyone concerned with the use of models to support decision making. PMID:22990082

  8. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Applicability of current good manufacturing... AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.2 Applicability of current good...

  9. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Applicability of current good manufacturing... AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.2 Applicability of current good...

  10. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Applicability of current good manufacturing... AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.2 Applicability of current good...

  11. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Applicability of current good manufacturing... AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.2 Applicability of current good...

  12. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Applicability of current good manufacturing... AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.2 Applicability of current good...

  13. PRACTICAL SIMULATION OF COMPOSTING IN THE LABORATORY

    EPA Science Inventory

    A closed incubation system was developed for laboratory simulation of composting conditions at the interior of a large compost pile. A conductive heat flux control system (CHFC) was used to adjust the temperature of the internal wall to that of the compost center and compensate f...

  14. Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients

    PubMed Central

    Abdellah, Abubaker; Noordin, Mohamed Ibrahim; Wan Ismail, Wan Azman

    2013-01-01

    Pharmaceutical excipients are no longer inert materials but it is effective and able to improve the characteristics of the products’ quality, stability, functionality, safety, solubility and acceptance of patients. It can interact with the active ingredients and alter the medicament characteristics. The globalization of medicines’ supply enhances the importance of globalized good manufacturing practice (GMP) requirements for pharmaceutical excipients. This review was intended to assess the globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients. The review outcomes demonstrate that there is a lack of accurately defined methods to evaluate and measure excipients’ safety. Furthermore good manufacturing practice requirements for excipients are not effectively globalized. PMID:25685037

  15. Good manufacturing practice: manufacturing of a nerve agent antidote nanoparticle suspension.

    PubMed

    Clark, Andrew P-Z; Dixon, Hong; Cantu, Norma L; Cabell, Larry A; McDonough, Joe A

    2013-01-01

    We have established a current good manufacturing practice (GMP) manufacturing process to produce a nanoparticle suspension of 1,1'-methylenebis-4-[(hydroxyimino)methyl]pyridinium dimethanesulfonate (MMB4 DMS) in cottonseed oil (CSO) as a nerve agent antidote for a Phase 1 clinical trial. Bis-pyridinium oximes such as MMB4 were previously developed for emergency treatment of organophosphate nerve agent intoxication. Many of these compounds offer efficacy superior to monopyridinium oximes, but they have poor thermal stability due to hydrolytic cleavage in aqueous solution. We previously developed a nonaqueous nanoparticle suspension to improve the hydrothermal stability, termed Enhanced Formulation (EF). An example of this formulation technology is a suspension of MMB4 DMS nanoparticles in CSO. Due to the profound effect of particle size distribution on product quality and performance, particle size must be controlled during the manufacturing process. Therefore, a particle size analysis method for MMB4 DMS in CSO was developed and validated to use in support of good laboratory practice/GMP development and production activities. Manufacturing of EF was accomplished by milling MMB4 DMS with CSO and zirconia beads in an agitator bead mill. The resulting bulk material was filled into 5-mL glass vials at a sterile fill facility and terminally sterilized by gamma irradiation. The clinical lot was tested and released, a Certificate of Analysis was issued, and a 3-year International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) stability study started. The drug product was placed in storage for Phase 1 clinical trial distribution. A dose delivery uniformity study was undertaken to ensure that the correct doses were delivered to the patients in the clinic. PMID:23929446

  16. A Research Informed Vision of Good Practice in Multicultural Teacher Education: Design Principles.

    ERIC Educational Resources Information Center

    Zeichner, Kenneth M.; Grant, Carl; Gay, Geneva; Gillette, Maureen; Valli, Linda; Villegas, Ana Maria

    1998-01-01

    Presents 14 design principles that explain good practice in multicultural preservice teacher education. The principles fall under the three main categories of (1) institutional and programmatic principles, (2) personnel principles, and (3) curriculum and instruction principles. (SM)

  17. Evidence-Based Laboratory Medicine: Is It Working in Practice?

    PubMed Central

    Price, Christopher P

    2012-01-01

    The principles of Evidence-Based Medicine have been established for about two decades, with the need for evidence-based clinical practice now being accepted in most health systems around the world. These principles can be employed in laboratory medicine. The key steps in evidence-based practice, namely (i) formulating the question; (ii) searching for evidence; (iii) appraising evidence; (iv) applying evidence; and (v) assessing the experience are all accepted but, as yet, translation into daily clinical and laboratory practice has been slow. Furthermore, the demand for evidence-based laboratory medicine (EBLM) has been slow to develop. There are many contrasting observations about laboratory medicine, for example (i) there is too much testing vs insufficient testing; (ii) testing is expensive vs laboratories are expected to generate income; and (iii) test results have little impact on outcomes vs test results are crucial to clinical decision making. However, there is little evidence to support any of these observations. Integrating the principles of EBLM into routine practice will help to resolve some of these issues by identifying (a) where laboratory medicine fits into the care pathway; (b) where testing is appropriate; (c) the nature and quality of evidence required to demonstrate the clinical utility of a test; (d) how the test result impacts on clinical actions; (e) where changes in the care pathway will occur; and (f) where benefit/value can be achieved. These answers will help to establish the culture of EBLM in clinical and laboratory practice. PMID:22363094

  18. Sexual conflict is not counterbalanced by good genes in the laboratory Drosophila melanogaster model system.

    PubMed

    Stewart, A D; Hannes, A M; Mirzatuny, A; Rice, W R

    2008-11-01

    Sexual conflict theory is based on the observation that females of many species are harmed through their interactions with males. Direct harm to females, however, can potentially be counterbalanced by indirect genetic benefits, where females make up for a reduction in offspring quantity by an increase in offspring quality through a generic increase in offspring fitness (good genes) and/or one restricted to the context of sexual selection (sexy sons). Here, we quantify the magnitude of the good genes mechanism of indirect benefits in a laboratory-adapted population of Drosophila melanogaster. We find that despite high-standing genetic variance for fitness, females gain at most only a modest benefit through the good genes form of indirect benefits--far too little to counterbalance the direct cost of male-induced harm. PMID:18681915

  19. Improving Student Laboratory Performance: How Much Practice Makes Perfect?

    ERIC Educational Resources Information Center

    Beasley, Warren

    1985-01-01

    Analyzes three approaches (physical, mental, combined practice) to improving freshman chemistry psychomotor laboratory skills. Although no significant differences were found between treatments, there were significant differences when each was compared to the control sections. Mental practice appears to offer an efficient methods for reinforcement…

  20. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following...

  1. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following...

  2. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following...

  3. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following...

  4. Good Practice Guide: Bringing a Social Capital Approach into the Teaching of Adult Literacy and Numeracy

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2010

    2010-01-01

    This good practice guide is based on research that looked at how to teach adult literacy and numeracy using a social capital approach. The guide suggests ways vocational education and training (VET) practitioners can adopt a social capital approach to their teaching practice. A social capital approach refers to the process in which networks are…

  5. The Seven Principles of Good Practice: A Framework for Evaluating On-Line Teaching

    ERIC Educational Resources Information Center

    Bangert, Arthur W.

    2004-01-01

    Traditionally, campus-based courses rely on student evaluations to provide instructors with feedback about their teaching effectiveness. However, current instructor evaluation instruments do not tap the essential teaching practices recommended for effective on-line teaching. This exploratory study used the Seven Principles of Good Practice of…

  6. Who Sleeps by Whom Revisited: A Method for Extracting the Moral Goods Implicit in Practice.

    ERIC Educational Resources Information Center

    Schweder, Richard A; And Others

    1995-01-01

    Explores the specific family practice of determining which family members share a bed or sleeping space. Discusses ways of extracting the moral principles implicit in the practice of arranging where family members sleep at night. Examines similarities and differences in the preferred moral goods of two culture regions--rural Hindu India and urban…

  7. Helping Displaced Older Workers Get Back into Employment: Good Practice Guide

    ERIC Educational Resources Information Center

    Callahan, Victor J.; Bowman, Kaye

    2015-01-01

    This good practice guide is based on the report "Industry Restructuring and Job Loss: Helping Older Workers Get Back into Employment" by Victor J. Callan and Kaye Bowman. The aim of the research was to identify evidence-based practices that led to successful skills transfer, re-skilling, training and the attainment of new jobs for older…

  8. Discrimination and Good Practice Activities in Education: Trends and Developments in the 27 EU Member States

    ERIC Educational Resources Information Center

    Pollak, Alexander

    2008-01-01

    The European Union Agency for Fundamental Rights collects, through its network of observation points, information on discrimination and good practice in the areas of legislation, employment, housing, racist violence, and education. Data on education includes information on: access to education for vulnerable groups, discriminatory practices,…

  9. Barriers to Implementation of Optimal Laboratory Biosafety Practices in Pakistan.

    PubMed

    Shakoor, Sadia; Shafaq, Humaira; Hasan, Rumina; Qureshi, Shahida M; Dojki, Maqboola; Hughes, Molly A; Zaidi, Anita K M; Khan, Erum

    2016-01-01

    The primary goal of biosafety education is to ensure safe practices among workers in biomedical laboratories. Despite several educational workshops by the Pakistan Biological Safety Association (PBSA), compliance with safe practices among laboratory workers remains low. To determine barriers to implementation of recommended biosafety practices among biomedical laboratory workers in Pakistan, we conducted a questionnaire-based survey of participants attending 2 workshops focusing on biosafety practices in Karachi and Lahore in February 2015. Questionnaires were developed by modifying the BARRIERS scale in which respondents are required to rate barriers on a 1-4 scale. Nineteen of the original 29 barriers were included and subcategorized into 4 groups: awareness, material quality, presentation, and workplace barriers. Workshops were attended by 64 participants. Among barriers that were rated as moderate to great barriers by at least 50% of respondents were: lack of time to read biosafety guidelines (workplace subscale), lack of staff authorization to change/improve practice (workplace subscale), no career or self-improvement advantages to the staff for implementing optimal practices (workplace subscale), and unclear practice implications (presentation subscale). A lack of recognition for employees' rights and benefits in the workplace was found to be a predominant reason for a lack of compliance. Based on perceived barriers, substantial improvement in work environment, worker facilitation, and enabling are needed for achieving improved or optimal biosafety practices in Pakistan. PMID:27400192

  10. 78 FR 22887 - Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-17

    ... Current Good Manufacturing Practices Framework for Preventing Cross- Contamination; Availability AGENCY... health risks associated with cross-reactivity. Although the existing current good manufacturing practices (CGMP) regulations require separation of manufacturing facilities to avoid cross-contamination, the...

  11. From Evidence to Best Practice in Laboratory Medicine

    PubMed Central

    Horvath, A Rita

    2013-01-01

    Laboratory tests offer value if they provide benefit to patients at acceptable costs. Laboratory testing is one of the most widely used diagnostic interventions supporting medical decisions, yet evidence demonstrating its value and impact on health outcomes is limited. This contributes to wide variations in test utilisation including underdiagnosis, overdiagnosis and misdiagnosis, which may impact the quality and the clinical- and cost-effectiveness of care and patient safety. Therefore implementing evidence into the care of patients is a moral and social imperative to laboratory professionals and all health care staff. This review investigates the reasons research does not get into practice, or only does with a very long delay. Apart from reviewing the common barriers to implementation, it also discusses the drivers of inappropriate test utilisation. By reviewing the theoretical and practical aspects of implementation science, recommendations are made for approaches that are thought to be most effective and that can be adopted to close the gap between evidence and practice, and to facilitate evidence-based laboratory medicine. Passive dissemination of the evidence and educational interventions are insufficient and do not offer sustainable solutions. A multifaceted and individualised implementation strategy, including individually tailored academic detailing, reminder systems, clinical decision support systems, feedback on performance, and participation of doctors and laboratory professionals in quality improvement activities addressing test selection and interpretation and in clinical audits, has greater potential for success. Examples of these initiatives at the laboratory and clinical interface are provided with links to valuable resources. PMID:24151341

  12. Research and implementation of good agricultural practice for traditional Chinese medicinal materials in Jilin Province, China

    PubMed Central

    Li, Changtian; Yan, Zhengfei; Zhang, Lianxue; Li, Yu

    2014-01-01

    Jilin Province is one of the principal production bases of traditional Chinese medicine (TCM) in China with its typical preponderance in TCM resources, research and development power, and industrialization capacity. The province has 2,790 species of TCM materials in total. Over 20% of the TCM materials in common use are from Jilin Province. The province has established 36 good agricultural practice bases for 22 typical TCMs. The overall situation, in terms of collection, processing, and preparation, and the implementation of good agricultural practice of TCM materials in Jilin Province are summarized. PMID:25379000

  13. Establishing Good Practices for Exposure–Response Analysis of Clinical Endpoints in Drug Development

    PubMed Central

    Overgaard, RV; Ingwersen, SH; Tornøe, CW

    2015-01-01

    This tutorial aims at promoting good practices for exposure–response (E-R) analyses of clinical endpoints in drug development. The focus is on practical aspects of E-R analyses to assist modeling scientists with a process of performing such analyses in a consistent manner across individuals and projects and tailored to typical clinical drug development decisions. This includes general considerations for planning, conducting, and visualizing E-R analyses, and how these are linked to key questions. PMID:26535157

  14. Impact of Laboratory Practices on Interlaboratory Variability in Therapeutic Drug Monitoring of Immunosuppressive Drugs.

    PubMed

    Christians, Uwe; Vinks, Alexander A; Langman, Loralie J; Clarke, William; Wallemacq, Pierre; van Gelder, Teun; Renjen, Varun; Marquet, Pierre; Meyer, Eric J

    2015-12-01

    The immunosuppressants cyclosporine, tacrolimus, sirolimus, everolimus, and probably also mycophenolic acid require therapeutic drug monitoring (TDM)-guided dosing to ensure that blood concentrations are kept within the target range in transplant patients. Reliable, accurate, and precise test methods are therefore essential to effectively monitor levels and to make proper dose adjustments. Data from proficiency testing programs have shown substantial interlaboratory variability. Only few attempts have been made to study the underlying causes. The aim of this study was to systematically document current practices used for immunosuppressant drug TDM in clinical laboratories and identify methodological and practice differences, which may cause the variability observed among laboratories. Data collection was primarily conducted by a structured Web-based survey. Invitations to participate in the survey were distributed to clinical laboratories providing immunosuppressant drug TDM. Surveys were completed by 76 laboratories in 14 countries. The results of our survey suggest that there are 3 main reasons for interlaboratory variability: (1) lack of standardization of laboratory procedures and workflows starting with sample collection and handling, (2) lack of use of appropriate reference materials (eg, isotope-labeled internal standards for liquid chromatography-tandem mass spectroscopy), and (3) poor compliance with internationally accepted good laboratory practice guidelines (eg, related to quality control, quality assurance, validation, training of personnel). The results of the survey also suggest that interlaboratory variability is a multifactorial problem. Technical-level consensus on laboratory operational procedures, quality systems, and personnel training will be of great importance to improve quality and interlaboratory comparability. PMID:26291980

  15. Multiple Criteria Decision Analysis for Health Care Decision Making--Emerging Good Practices: Report 2 of the ISPOR MCDA Emerging Good Practices Task Force.

    PubMed

    Marsh, Kevin; IJzerman, Maarten; Thokala, Praveen; Baltussen, Rob; Boysen, Meindert; Kaló, Zoltán; Lönngren, Thomas; Mussen, Filip; Peacock, Stuart; Watkins, John; Devlin, Nancy

    2016-01-01

    Health care decisions are complex and involve confronting trade-offs between multiple, often conflicting objectives. Using structured, explicit approaches to decisions involving multiple criteria can improve the quality of decision making. A set of techniques, known under the collective heading, multiple criteria decision analysis (MCDA), are useful for this purpose. In 2014, ISPOR established an Emerging Good Practices Task Force. The task force's first report defined MCDA, provided examples of its use in health care, described the key steps, and provided an overview of the principal methods of MCDA. This second task force report provides emerging good-practice guidance on the implementation of MCDA to support health care decisions. The report includes: a checklist to support the design, implementation and review of an MCDA; guidance to support the implementation of the checklist; the order in which the steps should be implemented; illustrates how to incorporate budget constraints into an MCDA; provides an overview of the skills and resources, including available software, required to implement MCDA; and future research directions. PMID:27021745

  16. Sandia National Laboratories ASCI Applications Software Quality Engineering Practices

    SciTech Connect

    ZEPPER, JOHN D.; ARAGON, KATHRYN MARY; ELLIS, MOLLY A.; BYLE, KATHLEEN A.; EATON, DONNA SUE

    2003-04-01

    This document provides a guide to the deployment of the software verification activities, software engineering practices, and project management principles that guide the development of Accelerated Strategic Computing Initiative (ASCI) applications software at Sandia National Laboratories (Sandia). The goal of this document is to identify practices and activities that will foster the development of reliable and trusted products produced by the ASCI Applications program. Document contents include an explanation of the structure and purpose of the ASCI Quality Management Council, an overview of the software development lifecycle, an outline of the practices and activities that should be followed, and an assessment tool.

  17. Analysing Classroom Discourse: Practical Work in the Biology Laboratory.

    ERIC Educational Resources Information Center

    Jimenez-Aleixandre, Maria Pilar; Diaz de Bustamante, Joaquin

    This study is part of a larger study on the problems that high school students' have in the interpretation and production of drawings and graphic representations in practical work in the biology laboratory, specifically with the use of the microscope. This part of the study focuses on classroom discourse among students and teacher as they use the…

  18. An Analysis of Inservice Education Practices for Hospital Laboratory Personnel.

    ERIC Educational Resources Information Center

    Bonke, Barbara A.; And Others

    1988-01-01

    A study looked at inservice practices in clinical laboratories and at managers' perceptions of the impact and cost effectiveness of those activities. Findings indicate that most do not have an inservice budget and that new employee orientation, policy and procedure discussion, and instrumentation instruction are most effective. (JOW)

  19. A Laboratory Practical Exam for High School Chemistry

    ERIC Educational Resources Information Center

    Rhodes, Michelle M.

    2010-01-01

    A station-based laboratory practical exam for first-year high school chemistry students is described. Students move individually through six stations meant to authentically assess both basic lab skills and problem-solving skills utilized throughout the year. The exam can be completed in an approximately 85 min lab period and can be easily adapted…

  20. Leading in practice: a case study of how health visitors share and develop good practice.

    PubMed

    Brigham, Lindsay; Maxwell, Claire; Smith, Ann

    2012-05-01

    The aim of this study was to find out more about health visitors' current situated practice in the context of national policy drivers outlining a new lead role for them in delivering co-ordinated and integrated services for children and families, tailored to local needs. The study focused on health visitors within a recently merged primary care trust and a qualitative approach was adopted with use of focus groups to generate data. The transcripts were subsequently analysed for key themes and dimensions. These related to how health visitors defined their own role and the skills with which they carried it out, the development of their expertise, role tensions and factors affecting leadership development. By drawing together the grounded experience of health visitors, policy drivers and theoretical interpretations a rich picture of existing practices was established, with recommendations made to promote distributed leadership and change. PMID:22792841

  1. Current Good Manufacturing Practice Production of an Oncolytic Recombinant Vesicular Stomatitis Viral Vector for Cancer Treatment

    PubMed Central

    Meseck, M.; Derecho, I.; Lopez, P.; Knoblauch, C.; McMahon, R.; Anderson, J.; Dunphy, N.; Quezada, V.; Khan, R.; Huang, P.; Dang, W.; Luo, M.; Hsu, D.; Woo, S.L.C.; Couture, L.

    2011-01-01

    Abstract Vesicular stomatitis virus (VSV) is an oncolytic virus currently being investigated as a promising tool to treat cancer because of its ability to selectively replicate in cancer cells. To enhance the oncolytic property of the nonpathologic laboratory strain of VSV, we generated a recombinant vector [rVSV(MΔ51)-M3] expressing murine gammaherpesvirus M3, a secreted viral chemokine-binding protein that binds to a broad range of mammalian chemokines with high affinity. As previously reported, when rVSV(MΔ51)-M3 was used in an orthotopic model of hepatocellular carcinoma (HCC) in rats, it suppressed inflammatory cell migration to the virus-infected tumor site, which allowed for enhanced intratumoral virus replication leading to increased tumor necrosis and substantially prolonged survival. These encouraging results led to the development of this vector for clinical translation in patients with HCC. However, a scalable current Good Manufacturing Practice (cGMP)-compliant manufacturing process has not been described for this vector. To produce the quantities of high-titer virus required for clinical trials, a process that is amenable to GMP manufacturing and scale-up was developed. We describe here a large-scale (50-liter) vector production process capable of achieving crude titers on the order of 109 plaque-forming units (PFU)/ml under cGMP. This process was used to generate a master virus seed stock and a clinical lot of the clinical trial agent under cGMP with an infectious viral titer of approximately 2 × 1010 PFU/ml (total yield, 1 × 1013 PFU). The lot has passed all U.S. Food and Drug Administration-mandated release testing and will be used in a phase 1 clinical translational trial in patients with advanced HCC. PMID:21083425

  2. Current good manufacturing practice production of an oncolytic recombinant vesicular stomatitis viral vector for cancer treatment.

    PubMed

    Ausubel, L J; Meseck, M; Derecho, I; Lopez, P; Knoblauch, C; McMahon, R; Anderson, J; Dunphy, N; Quezada, V; Khan, R; Huang, P; Dang, W; Luo, M; Hsu, D; Woo, S L C; Couture, L

    2011-04-01

    Vesicular stomatitis virus (VSV) is an oncolytic virus currently being investigated as a promising tool to treat cancer because of its ability to selectively replicate in cancer cells. To enhance the oncolytic property of the nonpathologic laboratory strain of VSV, we generated a recombinant vector [rVSV(MΔ51)-M3] expressing murine gammaherpesvirus M3, a secreted viral chemokine-binding protein that binds to a broad range of mammalian chemokines with high affinity. As previously reported, when rVSV(MΔ51)-M3 was used in an orthotopic model of hepatocellular carcinoma (HCC) in rats, it suppressed inflammatory cell migration to the virus-infected tumor site, which allowed for enhanced intratumoral virus replication leading to increased tumor necrosis and substantially prolonged survival. These encouraging results led to the development of this vector for clinical translation in patients with HCC. However, a scalable current Good Manufacturing Practice (cGMP)-compliant manufacturing process has not been described for this vector. To produce the quantities of high-titer virus required for clinical trials, a process that is amenable to GMP manufacturing and scale-up was developed. We describe here a large-scale (50-liter) vector production process capable of achieving crude titers on the order of 10(9) plaque-forming units (PFU)/ml under cGMP. This process was used to generate a master virus seed stock and a clinical lot of the clinical trial agent under cGMP with an infectious viral titer of approximately 2 × 10(10) PFU/ml (total yield, 1 × 10(13) PFU). The lot has passed all U.S. Food and Drug Administration-mandated release testing and will be used in a phase 1 clinical translational trial in patients with advanced HCC. PMID:21083425

  3. How good are the internal controls in your group practice? Ten questions to contemplate.

    PubMed

    Grant, Barbara J; Foley, Lori A

    2002-01-01

    Internal controls are the methods and procedures used by any business to prevent or detect errors, safeguard assets (especially cash) from being misappropriated, and encourage staff adherence to prescribed managerial policies. Internal controls in a medical practice differ depending on the size and complexity of the practice. The key, however, is that they prevent or detect errors and efforts to circumvent the established policies and procedures of the organization. How good are the internal controls in your group practice? This article identifies ten questions you should use to evaluate your risk of asset misappropriation. PMID:12122813

  4. Multiple Images, Common Threads. Case Studies of Good Practice in Adult Community Education.

    ERIC Educational Resources Information Center

    Bradshaw, Delia

    This document presents 10 case studies of adult community education programs (ACE) in the state of Victoria, Australia, in the mid 1990s, that were identified as exemplifying the following principles of good practice in ACE: expansiveness, integration, responsiveness, innovation, belonging, explicitness, autonomy, accessibility, synthesis, and…

  5. Formative Assessment and Self-Regulated Learning: A Model and Seven Principles of Good Feedback Practice

    ERIC Educational Resources Information Center

    Nicol, David J.; Macfarlane-Dick, Debra

    2006-01-01

    The research on formative assessment and feedback is reinterpreted to show how these processes can help students take control of their own learning, i.e. become self-regulated learners. This reformulation is used to identify seven principles of good feedback practice that support self-regulation. A key argument is that students are already…

  6. Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds.

    PubMed

    Mentz, Robert J; Hernandez, Adrian F; Berdan, Lisa G; Rorick, Tyrus; O'Brien, Emily C; Ibarra, Jenny C; Curtis, Lesley H; Peterson, Eric D

    2016-03-01

    Randomized, clinical trials are commonly regarded as the highest level of evidence to support clinical decisions. Good Clinical Practice guidelines have been constructed to provide an ethical and scientific quality standard for trials that involve human subjects in a manner aligned with the Declaration of Helsinki. Originally designed to provide a unified standard of trial data to support submission to regulatory authorities, the principles may also be applied to other studies of human subjects. Although the application of Good Clinical Practice principles generally led to improvements in the quality and consistency of trial operations, these principles have also contributed to increasing trial complexity and costs. Alternatively, the growing availability of electronic health record data has facilitated the possibility for streamlined pragmatic clinical trials. The central tenets of Good Clinical Practice and pragmatic clinical trials represent potential tensions in trial design (stringent quality and highly efficient operations). In the present article, we highlight potential areas of discordance between Good Clinical Practice guidelines and the principles of pragmatic clinical trials and suggest strategies to streamline study conduct in an ethical manner to optimally perform clinical trials in the electronic age. PMID:26927005

  7. Chickering's Seven Principles of Good Practice: Student Attrition in Community College Online Courses

    ERIC Educational Resources Information Center

    Tirrell, Tim; Quick, Don

    2012-01-01

    As online enrollments escalate, so does concern about student attrition rates. There is an abundance of literature addressing student success in online courses, particularly using constructivist learning theories to create engaging learning experiences. Also emerging from the literature is the "Seven principles of good instructional practice" by…

  8. A Critical Analysis of the INQAAHE Guidelines of Good Practice for Higher Education Quality Assurance Agencies

    ERIC Educational Resources Information Center

    Blackmur, Douglas

    2008-01-01

    The International Network of Quality Assurance Agencies in Higher Education's Guidelines of Good Practice by higher education quality assurance agencies need substantial revision before they can be considered adequate by stakeholders in any national higher education system. Various revisions are proposed in this article. But the International…

  9. The Euroversity Good Practice Framework (EGPF) and Its Application to Minority Languages and Elder Learners

    ERIC Educational Resources Information Center

    Motteram, Gary; Koenraad, Ton; Outakoski, Hanna; Jauregi, Kristi; Molka-Danielsen, Judith; Schneider, Christel

    2014-01-01

    The Euroversity Network project (2011-2014) has built a Good Practice Framework (GPF) that functions as a heuristic for course and activity designers wishing to develop courses and other materials for use in a range of virtual worlds. This framework has been tested with a number of courses during the running of the project and the aim is that it…

  10. Encouraging Good Writing Practice in First-Year Psychology Students: An Intervention Using Turnitin

    ERIC Educational Resources Information Center

    Betts, Lucy R.; Bostock, Stephen J.; Elder, Tracey J.; Trueman, Mark

    2012-01-01

    There is growing concern among many regarding plagiarism within student writing. This has promoted investigation into both the factors that predict plagiarism and potential methods of reducing plagiarism. Consequently, we developed and evaluated an intervention to enhance good practice within academic writing through the use of the plagiarism…

  11. The INQAAHE Guidelines of Good Practice for External Quality Assurance Agencies: Assessment and Next Steps

    ERIC Educational Resources Information Center

    Morse, Jean Avnet

    2006-01-01

    INQAAHE is working to improve the portability of degrees and credits across national boundaries. By defining "good practices" for quality assurance agencies, INQAAHE will promote mutual recognition among agencies in different countries and the acceptance of their accreditation decisions outside their own country. This will allow students and…

  12. Creating Opportunities: Good Practice in Small Business Training for Australian Rural Women.

    ERIC Educational Resources Information Center

    Simpson, Lyn; Daws, Leonie; Wood, Leanne

    2002-01-01

    To overcome barriers to participation in small business training faced by rural Australian women, training needs and delivery issues were identified and a good practice matrix was developed with the following components: marketing, content, delivery, support, impact, and innovation. Underlying principles included unique needs, diversity, use of…

  13. Singing in Primary Schools: Case Studies of Good Practice in Whole Class Vocal Tuition

    ERIC Educational Resources Information Center

    Lamont, Alexandra; Daubney, Alison; Spruce, Gary

    2012-01-01

    Within the context of British initiatives in music education such as the Wider Opportunities programme in England and the recommendations of the Music Manifesto emphasising the importance of singing in primary schools, the current paper explores examples of good practice in whole-class vocal tuition. The research included seven different primary…

  14. Building Skills and Qualifications among SME Employees. Leonardo da Vinci Good Practices Series.

    ERIC Educational Resources Information Center

    Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

    This document profiles 10 European programs that exemplify good practice in building skills and qualifications among employees of small and medium enterprises (SMEs). The programs profiled are as follows: (1) TRICTSME (a program providing World Wide Web-based information and communication technologies training for SMEs in manufacturing); (2)…

  15. FLUID MODELING DEMONSTRATION OF GOOD-ENGINEERING-PRACTICE STACK HEIGHT IN COMPLEX TERRAIN

    EPA Science Inventory

    A demonstration study using fluid modeling to determine the good-engineering-practice (GEP) stack height for a power plant installation in complex terrain is discussed. The site chosen for this demonstration study was the Clinch River Power Plant in southwestern Virginia, and a 1...

  16. Accommodating Learning Styles: Relevance and Good Practice in Vocational Education and Training--Supporting Documents

    ERIC Educational Resources Information Center

    Smith, Peter; Dalton, Jennifer; Henry, John

    2005-01-01

    This document was produced by the author(s) based on their research for the Australian report, "Accommodating Learning Styles: Relevance and Good Practice in Vocational Education and Training," and contains three parts. Part 1, Research Methodology and Findings (Peter Smith and Jennifer Dalton), contains: (1) Research Questions; (2) Research…

  17. Social and Occupational Integration of Disadvantaged People. Leonardo da Vinci Good Practices Series.

    ERIC Educational Resources Information Center

    Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

    This document profiles nine European programs that exemplify good practice in social and occupational integration of disadvantaged people. The programs profiled are as follows: (1) Restaurant Venezia (a CD-ROM program to improve the reading and writing skills of young people in Luxembourg who have learning difficulties); (2) an integrated…

  18. Identification of Good Practices in the Implementation of Innovative Learning Methodologies

    ERIC Educational Resources Information Center

    Lincaru, Cristina; Ciuca, Vasilica; Grecu, Liliana; Atanasiu, Draga; Dragoiu, Codruta

    2011-01-01

    We intend to present the partial issues resulted from the development of the European Project DeInTRA "cooperation for innovative training methodologies deployment in the European Labour Market"--Stage 4: Identification of good practices in the implementation of innovative learning methodologies. This project is included into the Lifelong Learning…

  19. Guide of good practices for occupational radiological protection in plutonium facilities

    SciTech Connect

    1998-06-01

    This Technical Standard (TS) does not contain any new requirements. Its purpose is to provide guides to good practice, update existing reference material, and discuss practical lessons learned relevant to the safe handling of plutonium. the technical rationale is given to allow US Department of Energy (DOE) health physicists to adapt the recommendations to similar situations throughout the DOE complex. Generally, DOE contractor health physicists will be responsible to implement radiation protection activities at DOE facilities and DOE health physicists will be responsible for oversight of those activities. This guidance is meant to be useful for both efforts. This TS replaces PNL-6534, Health Physics Manual of Good Practices for Plutonium Facilities, by providing more complete and current information and by emphasizing the situations that are typical of DOE`s current plutonium operations; safe storage, decontamination, and decommissioning (environmental restoration); and weapons disassembly.

  20. Grounded theory in medical laboratory science expert practice development.

    PubMed

    Leibach, Elizabeth Kenimer

    2011-01-01

    Grounded theory and methods related to expert practice development in medical laboratory science were described using data from a large national survey of medical laboratory scientists (MLS) overlaid on findings from analysis of expert practice domains reported in nursing literature. An extensive focus group/expert review iterative process followed by a survey of MLS practitioners produced 25 critical thinking (CT) behaviors important in expert practice. Factor analysis was applied to discern common threads or themes linking the CT behaviors. The 25 important CT behaviors were reduced to a 7-factor structure representing constructs underlying the individual, observable CT behaviors. This 7-factor structure in MLS was compared to the 7 practice domains identified in expert nursing practice. The comparison yielded commonality between MLS and nursing in CT behaviors observed in the 7 expert practice domains of both professions: professional techniques, caring communication, growing professionally, setting priorities, practicing with judgment, anticipating/revising, and creating unique meaning. Emergent grounded theory is that (1) critical thinking is a metaprocess that facilitates learning by interlinking the more basic processes associated with different learning orientations: cognitivist, behaviorist, humanist (affective), and situated/contextual learning, (2) CT behaviors are observable events following from the CT metaprocess, and (3) observations of CT behaviors increase as practice advances from novice to expert. Identification and definition of CT behaviors, i.e., practice competencies, along the continuum of novice to expert can serve as the foundation for MLS curriculum and instructional design as well as measurement and evaluation in both formal and continuing education settings. PMID:22420229

  1. Advances in participatory occupational health aimed at good practices in small enterprises and the informal sector.

    PubMed

    Kogi, Kazutaka

    2006-01-01

    Participatory programmes for occupational risk reduction are gaining importance particularly in small workplaces in both industrially developing and developed countries. To discuss the types of effective support, participatory steps commonly seen in our "work improvement-Asia" network are reviewed. The review covered training programmes for small enterprises, farmers, home workers and trade union members. Participatory steps commonly focusing on low-cost good practices locally achieved have led to concrete improvements in multiple technical areas including materials handling, workstation ergonomics, physical environment and work organization. These steps take advantage of positive features of small workplaces in two distinct ways. First, local key persons are ready to accept local good practices conveyed through personal, informal approaches. Second, workers and farmers are capable of understanding technical problems affecting routine work and taking flexible actions leading to solving them. This process is facilitated by the use of locally adjusted training tools such as local good examples, action checklists and group work methods. It is suggested that participatory occupational health programmes can work in small workplaces when they utilize low-cost good practices in a flexible manner. Networking of these positive experiences is essential. PMID:16610530

  2. Sandia National Laboratories ASCI Applications Software Quality Engineering Practices

    SciTech Connect

    ZEPPER, JOHN D.; ARAGON, KATHRYN MARY; ELLIS, MOLLY A.; BYLE, KATHLEEN A.; EATON, DONNA SUE

    2002-01-01

    This document provides a guide to the deployment of the software verification activities, software engineering practices, and project management principles that guide the development of Accelerated Strategic Computing Initiative (ASCI) applications software at Sandia National Laboratories (Sandia). The goal of this document is to identify practices and activities that will foster the development of reliable and trusted products produced by the ASCI Applications program. Document contents include an explanation of the structure and purpose of the ASCI Quality Management Council, an overview of the software development lifecycle, an outline of the practices and activities that should be followed, and an assessment tool. These sections map practices and activities at Sandia to the ASCI Software Quality Engineering: Goals, Principles, and Guidelines, a Department of Energy document.

  3. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3.

    PubMed

    Battisti, Wendy P; Wager, Elizabeth; Baltzer, Lise; Bridges, Dan; Cairns, Angela; Carswell, Christopher I; Citrome, Leslie; Gurr, James A; Mooney, LaVerne A; Moore, B Jane; Peña, Teresa; Sanes-Miller, Carol H; Veitch, Keith; Woolley, Karen L; Yarker, Yvonne E

    2015-09-15

    This updated Good Publication Practice (GPP) guideline, known as GPP3, builds on earlier versions and provides recommendations for individuals and organizations that contribute to the publication of research results sponsored or supported by pharmaceutical, medical device, diagnostics, and biotechnology companies. The recommendations are designed to help individuals and organizations maintain ethical and transparent publication practices and comply with legal and regulatory requirements. These recommendations cover publications in peer-reviewed journals and presentations (oral or poster) at scientific congresses. The International Society for Medical Publication Professionals invited more than 3000 professionals worldwide to apply for a position on the steering committee, or as a reviewer, for this guideline. The GPP2 authors reviewed all applications (n = 241) and assembled an 18-member steering committee that represented 7 countries and a diversity of publication professions and institutions. From the 174 selected reviewers, 94 sent comments on the second draft, which steering committee members incorporated after discussion and consensus. The resulting guideline includes new sections (Principles of Good Publication Practice for Company-Sponsored Medical Research, Data Sharing, Studies That Should Be Published, and Plagiarism), expands guidance on the International Committee of Medical Journal Editors' authorship criteria and common authorship issues, improves clarity on appropriate author payment and reimbursement, and expands information on the role of medical writers. By following good publication practices (including GPP3), individuals and organizations will show integrity; accountability; and responsibility for accurate, complete, and transparent reporting in their publications and presentations. PMID:26259067

  4. Good practices and health policy analysis in European sports stadia: results from the 'Healthy Stadia' project.

    PubMed

    Drygas, Wojciech; Ruszkowska, Joanna; Philpott, Matthew; Björkström, Olav; Parker, Mike; Ireland, Robin; Roncarolo, Federico; Tenconi, Maria

    2013-06-01

    Sport plays an important role within society and sports stadia provide significant settings for public health strategies. In addition to being places of mass gathering, stadia are often located in less affluent areas and are traditionally attended by 'harder to reach' communities. Unfortunately sports stadia and the clubs they host are rarely perceived as places that promote healthy lifestyles. Fast food, alcohol and tobacco are commonly advertized, served and consumed during sports games giving the spectators and TV fans contradictory messages concerning healthy choices. As part of a wider programme of work part-funded by the European Union, a study was therefore designed to explore current 'good practice' relating to positive health interventions in sports stadia across a number of European countries. Using a specially designed questionnaire, information about health policies and good practices relating to food offerings in stadia, physical activity promotion among local communities, tobacco policy, positive mental health initiatives, environmental sustainability practices and social responsibility policies were collected in 10 European countries (England and Northern Ireland, Finland, Georgia, Greece, Ireland, Italy, Latvia, Poland, Spain and Sweden) involving 88 stadia. The audit results show that stadia health policies differ considerably between specific countries and sports. Based on the literature analysed, the examples of good practices collected through the study, and the subsequent instigation of a European Healthy Stadia Network, it shows that there is considerable potential for stadia to become health promoting settings. PMID:22139638

  5. British Fertility Society Policy and Practice Committee: adjuvants in IVF: evidence for good clinical practice.

    PubMed

    Nardo, Luciano G; El-Toukhy, Tarek; Stewart, Jane; Balen, Adam H; Potdar, Neelam

    2015-03-01

    Optimisation of the environment favourable for satisfactory ovarian response to stimulation and successful embryo implantation remains at the core of assisted conception programmes. The evidence base for the routine use of different adjuvants, alone or in combination, for women undergoing their first in vitro fertilisation (IVF) treatment cycle and for those with poor prognosis is inadequate. The aim of this document is to update the last review of the available literature carried out by the British Fertility Society Policy and Practice Committee (BFS P&P) published in 2009 and to provide fertility professionals with evidence-based guidance and recommendations regarding the use of immunotherapy, vasodilators, uterine relaxants, aspirin, heparin, growth hormone, dehydroepiandrosterone, oestrogen and metformin as adjuvants in IVF. Unfortunately despite the lapse of 5 years since the last publication, there is still a lack of robust evidence for most of the adjuvants searched and large well-designed randomised controlled trials are still needed. One possible exception is metformin, which seems to have a positive effect in women with polycystic ovary syndrome undergoing IVF. Patients who are given other adjuvants on an empirical basis should always be informed of the lack of evidence and the potential side effects. PMID:25531921

  6. A guide to good practice in modeling semantics for authors and referees

    NASA Astrophysics Data System (ADS)

    Beven, Keith; Young, Peter

    2013-08-01

    This opinion piece makes some suggestions about guidelines for modeling semantics that can be referred to by authors and referees. We discuss descriptions of model structures, different forms of simulation and prediction, descriptions of different sources of uncertainty in modeling practice, the language of model validation, and concepts of predictability and fitness-for-purpose. While not expecting universal agreement on these suggestions, given the loose usage of words in the literature, we hope that the discussion of the issues involved will at least give pause for thought and encourage good practice in model development and applications.

  7. Practical methodological guide for hydrometric inter-laboratory organisation

    NASA Astrophysics Data System (ADS)

    Besson, David; Bertrand, Xavier

    2015-04-01

    Discharge measurements performed by the French governmental hydrometer team feed a national database. This data is available for general river flows knowkedge, flood forecasting, low water survey, statistical calculations flow, control flow regulatory and many other uses. Regularly checking the measurements quality and better quantifying its accuracy is therefore an absolute need. The practice of inter-laboratory comparison in hydrometry particularly developed during the last decade. Indeed, discharge measurement can not easily be linked to a standard. Therefore, on-site measurement accuracy control is very difficult. Inter-laboratory comparison is thus a practical solution to this issue. However, it needs some regulations in order to ease its practice and legitimize its results. To do so, the French government hydrometrics teams produced a practical methodological guide for hydrometric inter-laboratory organisation in destination of hydrometers community in view of ensure the harmonization of inter-laboratory comparison practices for different materials (ADCP, current meter on wadind rod or gauging van, tracer dilution, surface speed) and flow range (flood, low water). Ensure the results formalization and banking. The realisation of this practice guide is grounded on the experience of the governmental teams & their partners (or fellows), following existing approaches (Doppler group especially). The guide is designated to validate compliance measures and identify outliers : Hardware, methodological, environmental, or human. Inter-laboratory comparison provides the means to verify the compliance of the instruments (devices + methods + operators) and provides methods to determine an experimental uncertainty of the tested measurement method which is valid only for the site and the measurement conditions but does not address the calibration or periodic monitoring of the few materials. After some conceptual definitions, the guide describes the different stages of an

  8. Quality Management of the Immunohistochemistry Laboratory: A Practical Guide.

    PubMed

    Cates, Justin M M; Troutman, K Ashley

    2015-08-01

    Governmental regulations and most published guidelines do not provide specific guidance on implementation of quality management (QM) programs for immunohistochemistry (IHC) assays in Anatomic Pathology. QM of IHC consists of 3 main components: quality control, quality assurance, and quality improvement initiatives, each entailing distinctive but interrelated objectives. Discussion of the principles and some specific practices involved in these phases of QM of the IHC laboratory are therefore offered in this review, with an admitted emphasis on pragmatism. PMID:25203427

  9. Autoclaving practice in microbiology laboratories: report of a survey. The Public Health Laboratory Service Subcommittee on laboratory autoclaves.

    PubMed Central

    1978-01-01

    The performance of autoclaves in 27 laboratories, operated in accordance with the normal routine of local practice, has been monitored using thermometric equipment. Sterilising performance was unsatisfactory on 10 of 62 occasions, and cooling was inadequate on 52 of 60 occasions. PMID:649767

  10. Media fill for validation of a good manufacturing practice-compliant cell production process.

    PubMed

    Serra, Marta; Roseti, Livia; Bassi, Alessandra

    2015-01-01

    According to the European Regulation EC 1394/2007, the clinical use of Advanced Therapy Medicinal Products, such as Human Bone Marrow Mesenchymal Stem Cells expanded for the regeneration of bone tissue or Chondrocytes for Autologous Implantation, requires the development of a process in compliance with the Good Manufacturing Practices. The Media Fill test, consisting of a simulation of the expansion process by using a microbial growth medium instead of the cells, is considered one of the most effective ways to validate a cell production process. Such simulation, in fact, allows to identify any weakness in production that can lead to microbiological contamination of the final cell product as well as qualifying operators. Here, we report the critical aspects concerning the design of a Media Fill test to be used as a tool for the further validation of the sterility of a cell-based Good Manufacturing Practice-compliant production process. PMID:25096172

  11. Promoting good health research practice in low- and middle-income countries

    PubMed Central

    Mahendradhata, Yodi; Nabieva, Jamila; Ahmad, Riris Andono; Henley, Patricia; Launois, Pascal; Merle, Corinne; Maure, Christine; Horstick, Olaf; Elango, Varalakshmi

    2016-01-01

    Background Good clinical practice (GCP) guidelines have been the source of improvement in the quality of clinical trials; however, there are limitations to the application of GCP in the conduct of health research beyond industry-sponsored clinical trials. The UNICEF/UNDP/World Bank/WHO Special Program for Research and Training in Tropical Disease is promoting good practice in all health research involving human through the Good Health Research Practice (GHRP) training program initiative. Objective To report the results of piloting the GHRP training program and formulate further steps to harness GHRP for promoting good practices in all health research involving human, particularly in low- and middle-income countries (LMICs). Design The objective of this training is to impart knowledge and skills for the application of ethical and quality principles to the design, conduct, recording, and reporting of health research involving human participants based on the level of risk, to ensure a fit-for-purpose quality system. This has been formulated into five sequential modules to be delivered in a 4-day course. Four courses have been organized in the pilot phase (2014–2015). The courses have been evaluated and assessed based on course feedback (quantitative and qualitative data) collected during course implementation and qualitative email-based pre- and post-course evaluation. Results Participants were highly satisfied with the course content and its organization. The relevance and applicability of the course content resulted in positive feedback and an articulated willingness to adapt and disseminate the course. Action points to strengthen the training program have been identified, and showed the imminent need to develop a consensus with a broader range of key stakeholders on the final set of GHRP standards and means for implementation. Conclusions There is an urgent need to harness the momentum to promote high-quality and ethical health research in LMICs through scaling

  12. Guide to good practices for training and qualification of instructors. DOE handbook

    SciTech Connect

    1996-03-01

    Purpose of this guide is to provide contractor training organizations with information that can be used to verify the adquacy and/or modify existing instructor training programs, or to develop new training programs. It contains good practices for the training and qualification of technical instructors and instructional technologists at DOE reactor and non-reactor nuclear facilities. It addresses the content of initial and continuing instructor training programs, evaluation of instructor training programs, and maintenance of instructor training records.

  13. Contextualizing practices across epistemic levels in the chemistry laboratory

    NASA Astrophysics Data System (ADS)

    Jiménez-Aleixandre, María-Pilar; Reigosa, Carlos

    2006-07-01

    The process of construction of meanings for the concepts of concentration and neutralization is explored in terms of contextualizing practices (Lemke, 1990, Talking Science. Language, Learning and Values, Norwood, NJ: Ablex) creation of meanings through connections established among actions and their context. This notion is expanded to include the connections established among concepts and their context of use, a solving problem task in a laboratory. The purpose is to document the process of meaning construction for these concepts and their transformation from mere terms into decisions and practical actions in a chemistry laboratory. We sought to combine this analysis with an epistemological focus, examining the relative epistemic status of the contextualizing practices. The conversations and actions of four grade 10 students and their teacher (second author) were recorded while solving an open task: to find the concentration of an HCl solution. The results show a progression in the process of contextualization, from an initial inability to use the concepts as part of the resources to complete the titration task, to the transformation of definitions into shared meaningful concepts that allow to take actions, combining theoretical resources with physical ones to solve the problem. A frame for categorizing contextualizing practices across epistemic levels is proposed and applied to the data.

  14. Students integrate knowledge acquisition and practical work in the laboratory.

    PubMed

    Agüera, E I; Sánchez-Hermosín, P; Díz-Pérez, J; Tovar, P; Camacho, R; Escribano, B M

    2015-09-01

    The aim of the present work was to transfer a wider concept of teamwork and self-learning to the laboratory, encouraging students' capabilities when seeking, acquiring, and processing knowledge. This educational innovation was carried out with a total of 38 students (fourth year of degree in Biology) in the area of physiology (Advances in Reproduction course) at University of Córdoba in Córdoba, Spain. The design of the project's application methodology consisted of establishing a way in which problems would be tackled in the practical classes. For this purpose, the different tasks were set up so that students could relate them to the concepts learned in the theory classes. On the first day of class, the project was presented to the students. Groups of two to three students worked in the laboratory and set up an outline of the protocol of the practical work that they had done. This outline was performed individually and sent to the lecturers through a learning management system (Moodle). The teachers gave feedback and assessed student submissions. Upon finishing the course, students completed a survey. The project-based learning method promotes practical self-learning on the part of students. This methodology demonstrated to us that it stimulates a critical and self-critical capacity in students, both individually and in groups, and that writing didactic practical material helped students to enhance their theory knowledge. The experiment was a success in view of the scores obtained upon finishing the subject. PMID:26330040

  15. Regulation of drugs and chemicals used by the poultry industry. Good manufacturing practices.

    PubMed

    Boyd, L H

    1994-09-01

    Good manufacturing practices (GMP) are required to be followed in the use of animal drugs to produce medicated feeds. The authority is found in the federal Food, Drug, and Cosmetic Act, which states that medicated feed can be deemed adulterated if GMP were not followed in its production. This authority has been translated into GMP regulations applicable to all medicated feed production. More detailed GMP are imposed on those using high potency sources of drugs that require a withdrawal period (Category II). Less detailed GMP are imposed on all other drug uses (Category I and lower potency sources of Category II). Facility registration, medicated feed applications, and biennial inspections are also imposed on those required to follow the more detailed GMP regulations. The basic thrust of the regulations is assurance that drug use is correct in all respects and that the integrity of all medicated and nonmedicated feeds is maintained. The objective is food free of illegal drug residues, i.e., food safety. The GMP regulations are based on joint industry-government endeavor and reflect the practical realities of feed manufacturing. They are, for all practical purposes, good business practices assuring that medicated feeds make a positive contribution to food production and consumer confidence. PMID:7800642

  16. Development of good modelling practice for phsiologically based pharmacokinetic models for use in risk assessment: The first steps

    EPA Science Inventory

    The increasing use of tissue dosimetry estimated using pharmacokinetic models in chemical risk assessments in multiple countries necessitates the need to develop internationally recognized good modelling practices. These practices would facilitate sharing of models and model eva...

  17. Evaluation of the Implementation of Good Handling Practices in Food and Beverage Areas of Hotels.

    PubMed

    Serafim, A L; Hecktheuer, L H R; Stangarlin-Fiori, L; Medeiros, L B; Martello, L; Machado, C E

    2015-11-01

    Because of the major international-level events that have recently been held in Brazil, concerns about the sensory and hygienic-sanitary conditions of food have increased. The objective of this study was to evaluate the implementation of good handling practices in food and beverage areas of hotels, with and without outsourced professional intervention. We evaluated 19 food and beverage areas in hotels in Porto Alegre, Rio do Sul, Brazil, using a checklist that was developed by a municipal surveillance team based on existing laws for good handling practices. The evaluation was done by a skilled professional in the food safety area on two occasions, at the beginning of the study (January to May 2013) and at the end (July to November 2014), and the establishments were classified as good, regular, or poor. After the baseline evaluation, an action plan listing the noncompliance found at each location was given to those responsible for the establishments, and a period of 1 year 6 months was stipulated for improvements to be made. In the repeat evaluation, those responsible for the establishments were asked whether they had hired an outsourced professional to assist them in the improvements. The hotels showed improvement during the repeat evaluation, but a significant increase in the percentage of overall adequacy was seen only in the food and beverages areas of the 12 hotels that used the intervention of an outsourced professional. The better percentage of adequacy in establishments with outsourced professional intervention underlines the importance of an external and impartial view of routine activities in the implementation of good handling practices. PMID:26555528

  18. Electroencephalographic neurofeedback: Level of evidence in mental and brain disorders and suggestions for good clinical practice.

    PubMed

    Micoulaud-Franchi, J-A; McGonigal, A; Lopez, R; Daudet, C; Kotwas, I; Bartolomei, F

    2015-12-01

    The technique of electroencephalographic neurofeedback (EEG NF) emerged in the 1970s and is a technique that measures a subject's EEG signal, processes it in real time, extracts a parameter of interest and presents this information in visual or auditory form. The goal is to effectuate a behavioural modification by modulating brain activity. The EEG NF opens new therapeutic possibilities in the fields of psychiatry and neurology. However, the development of EEG NF in clinical practice requires (i) a good level of evidence of therapeutic efficacy of this technique, (ii) a good practice guide for this technique. Firstly, this article investigates selected trials with the following criteria: study design with controlled, randomized, and open or blind protocol, primary endpoint related to the mental and brain disorders treated and assessed with standardized measurement tools, identifiable EEG neurophysiological targets, underpinned by pathophysiological relevance. Trials were found for: epilepsies, migraine, stroke, chronic insomnia, attentional-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, major depressive disorder, anxiety disorders, addictive disorders, psychotic disorders. Secondly, this article investigates the principles of neurofeedback therapy in line with learning theory. Different underlying therapeutic models are presented didactically between two continua: a continuum between implicit and explicit learning and a continuum between the biomedical model (centred on "the disease") and integrative biopsychosocial model of health (centred on "the illness"). The main relevant learning model is to link neurofeedback therapy with the field of cognitive remediation techniques. The methodological specificity of neurofeedback is to be guided by biologically relevant neurophysiological parameters. Guidelines for good clinical practice of EEG NF concerning technical issues of electrophysiology and of learning are suggested. These require validation by

  19. Health physics manual of good practices for plutonium facilities. [Contains glossary

    SciTech Connect

    Brackenbush, L.W.; Heid, K.R.; Herrington, W.N.; Kenoyer, J.L.; Munson, L.F.; Munson, L.H.; Selby, J.M.; Soldat, K.L.; Stoetzel, G.A.; Traub, R.J.

    1988-05-01

    This manual consists of six sections: Properties of Plutonium, Siting of Plutonium Facilities, Facility Design, Radiation Protection, Emergency Preparedness, and Decontamination and Decommissioning. While not the final authority, the manual is an assemblage of information, rules of thumb, regulations, and good practices to assist those who are intimately involved in plutonium operations. An in-depth understanding of the nuclear, physical, chemical, and biological properties of plutonium is important in establishing a viable radiation protection and control program at a plutonium facility. These properties of plutonium provide the basis and perspective necessary for appreciating the quality of control needed in handling and processing the material. Guidance in selecting the location of a new plutonium facility may not be directly useful to most readers. However, it provides a perspective for the development and implementation of the environmental surveillance program and the in-plant controls required to ensure that the facility is and remains a good neighbor. The criteria, guidance, and good practices for the design of a plutonium facility are also applicable to the operation and modification of existing facilities. The design activity provides many opportunities for implementation of features to promote more effective protection and control. The application of ''as low as reasonably achievable'' (ALARA) principles and optimization analyses are generally most cost-effective during the design phase. 335 refs., 8 figs., 20 tabs.

  20. Autonomy and Privacy in Clinical Laboratory Science Policy and Practice.

    PubMed

    Leibach, Elizabeth Kenimer

    2014-01-01

    Rapid advancements in diagnostic technologies coupled with growth in testing options and choices mandate the development of evidence-based testing algorithms linked to the care paths of the major chronic diseases and health challenges encountered most frequently. As care paths are evaluated, patient/consumers become partners in healthcare delivery. Clinical laboratory scientists find themselves firmly embedded in both quality improvement and clinical research with an urgent need to translate clinical laboratory information into knowledge required by practitioners and patient/consumers alike. To implement this patient-centered care approach in clinical laboratory science, practitioners must understand their roles in (1) protecting patient/consumer autonomy in the healthcare informed consent process and (2) assuring patient/consumer privacy and confidentiality while blending quality improvement study findings with protected health information. A literature review, describing the current ethical environment, supports a consultative role for clinical laboratory scientists in the clinical decision-making process and suggests guidance for policy and practice regarding the principle of autonomy and its associated operational characteristics: informed consent and privacy. PMID:26084151

  1. Guideline to good practices for types of maintenance activities at DOE nuclear facilities

    SciTech Connect

    Not Available

    1993-03-01

    The purpose of the Guideline to Good Practices for Types of Maintenance at DOE Nuclear Facilities is to provide contractor maintenance organizations with information that may be used for the development and implementation of a properly balanced corrective, preventive and predictive maintenance program at DOE nuclear facilities. This document is intended to be an example guideline for the implementation of DOE Order 4330.4A, Maintenance Management Program, Chapter II, Element 4. DOE contractors should not feel obligated to adopt all parts of this guide. Rather, they should use the information contained herein as a guide for developing maintenance programs that are applicable to their facility.

  2. From bad pharma to good pharma: aligning market forces with good and trustworthy practices through accreditation, certification, and rating.

    PubMed

    Miller, Jennifer E

    2013-01-01

    This article explores whether the bioethical performance and trustworthiness of pharmaceutical companies can be improved by harnessing market forces through the use of accreditation, certification, or rating. Other industries have used such systems to define best practices, set standards, and assess and signal the quality of services, processes, and products. These systems have also informed decisions in other industries about where to invest, what to buy, where to work, and when to regulate. Similarly, accreditation, certification, and rating programs can help drug companies address stakeholder concerns in four areas: clinical trial design and management, dissemination of clinical trial results, marketing practices, and the accessibility of medicines. To illuminate processes - such as conflicts of interests and revolving-door policies - that can jeopardize the integrity of accreditation, certification, and ratings systems, the article concludes with a consideration of recent failures of credit-rating agencies and a review of the regulatory capture literature. PMID:24088150

  3. Guide to good practices for notifications and investigation of abnormal events

    SciTech Connect

    Not Available

    1993-06-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Notifications, Chapter VII, and Investigation of Abnormal Events, Chapter VI, of Department of Energy (DOE) Order 5480.19, ``Conduct of Operations Requirements for DOE Facilities.`` The practices in this guide should be considered when planning or reviewing programs for notifications and investigation of abnormal events. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. ``Notifications`` and ``Investigation of Abnormal Events`` are elements of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for a coordinated notifications program and a consistent method for investigating abnormal events to promote safe and efficient operations.

  4. Guide to good practices for notifications and investigation of abnormal events

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Notifications, Chapter VII, and Investigation of Abnormal Events, Chapter VI, of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing programs for notifications and investigation of abnormal events. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Notifications and Investigation of Abnormal Events are elements of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for a coordinated notifications program and a consistent method for investigating abnormal events to promote safe and efficient operations.

  5. Good Publication Practice for Pharmaceutical Companies”: Where Are We Now?

    PubMed Central

    Wager, Elizabeth

    2005-01-01

    Abstract and Introduction Abstract Eighteen months on from the publication of “Good Publication Practice for Pharmaceutical Companies,” one member of the working group that developed these guidelines reflects on what they have achieved and what has changed since they were first developed. Introduction Pharmaceutical company publication practices have recently attracted the attention of journal editors, the mass media, and even been the subject of legal proceedings. The issue of the nonpublication of trial results moved from being a largely academic concern to the subject of newspaper headlines when GlaxoSmithKline was sued by the New York Attorney General.[1] The settlement included a commitment to make summaries of trial results available on the company Web site. At around the same time, other companies, such as Eli Lilly, announced similar policies.[2] Companies may have also been examining their publication policies in the light of the case against Pfizer-Warner-Lambert, which resulted in the company being fined $240 million and ordered to pay $152 million in damages for promoting the off-label use of gabapentin (Neurontin).[3] Evidence brought against the company included having “A ‘publication strategy’ that subsidized the production and dissemination of anecdotal reports favorable to off-label use of Neurontin,” which were “of no scientific value.” Some news items also mentioned the use of ghostwriters. It is tempting to believe that a great deal of time, effort, and even money might have been saved if companies had paid more attention to their publication practices. A set of guidelines on Good Publication Practice (GPP) for pharmaceutical companies were published in mid-2003.[4] This article reviews the history of the guidelines in light of the recent developments. PMID:16369385

  6. Irrigation water quality and the benefits of implementing good agricultural practices during tomato (Lycopersicum esculentum) production.

    PubMed

    Estrada-Acosta, M; Jiménez, M; Chaidez, C; León-Félix, J; Castro-Del Campo, N

    2014-07-01

    The implementation of good agricultural practices (GAP) from irrigation water to the tomato packaging process enhances the safety of fresh produce and its value throughout the food chain. The aim of the present study was to show that fresh produce farms that apply and enforce GAP could reduce the presence of Salmonella in finished produce. Samples were collected biweekly from six packing houses from the central region of Sinaloa, México, for the isolation of Salmonella spp by the ISO 6579:2002 method, and the isolated strains were serotyped and genotyped by the Kauffmman-White scheme and pulsed field gel electrophoresis (PFGE), respectively. Salmonella strains were detected in 13 (36.1 %) irrigation water samples, while only two tomato samples were positive (5.5 %). Eight different serotypes were identified in irrigation water, and Salmonella Oranienburg (34 %) was the most prevalent; however, only Salmonella Agona and Salmonella Weltevreden were present on tomatoes. Salmonella Oranienburg was the most widely dispersed and variable serotype, with 10 different PFGE profiles. Salmonella Weltevreden was isolated from both types of samples, albeit with distinct genetic profiles, implying that the sources of contamination differ. These results confirm the utility of implementing good agricultural practices to reduce Salmonella contamination in irrigation water and the packaging process. PMID:24682661

  7. Improving Consistency in Large Laboratory Courses: A Design for a Standardized Practical Exam

    ERIC Educational Resources Information Center

    Chen, Xinnian; Graesser, Donnasue; Sah, Megha

    2015-01-01

    Laboratory courses serve as important gateways to science, technology, engineering, and mathematics education. One of the challenges in assessing laboratory learning is to conduct meaningful and standardized practical exams, especially for large multisection laboratory courses. Laboratory practical exams in life sciences courses are frequently…

  8. Genomics Virtual Laboratory: A Practical Bioinformatics Workbench for the Cloud

    PubMed Central

    Afgan, Enis; Sloggett, Clare; Goonasekera, Nuwan; Makunin, Igor; Benson, Derek; Crowe, Mark; Gladman, Simon; Kowsar, Yousef; Pheasant, Michael; Horst, Ron; Lonie, Andrew

    2015-01-01

    Background Analyzing high throughput genomics data is a complex and compute intensive task, generally requiring numerous software tools and large reference data sets, tied together in successive stages of data transformation and visualisation. A computational platform enabling best practice genomics analysis ideally meets a number of requirements, including: a wide range of analysis and visualisation tools, closely linked to large user and reference data sets; workflow platform(s) enabling accessible, reproducible, portable analyses, through a flexible set of interfaces; highly available, scalable computational resources; and flexibility and versatility in the use of these resources to meet demands and expertise of a variety of users. Access to an appropriate computational platform can be a significant barrier to researchers, as establishing such a platform requires a large upfront investment in hardware, experience, and expertise. Results We designed and implemented the Genomics Virtual Laboratory (GVL) as a middleware layer of machine images, cloud management tools, and online services that enable researchers to build arbitrarily sized compute clusters on demand, pre-populated with fully configured bioinformatics tools, reference datasets and workflow and visualisation options. The platform is flexible in that users can conduct analyses through web-based (Galaxy, RStudio, IPython Notebook) or command-line interfaces, and add/remove compute nodes and data resources as required. Best-practice tutorials and protocols provide a path from introductory training to practice. The GVL is available on the OpenStack-based Australian Research Cloud (http://nectar.org.au) and the Amazon Web Services cloud. The principles, implementation and build process are designed to be cloud-agnostic. Conclusions This paper provides a blueprint for the design and implementation of a cloud-based Genomics Virtual Laboratory. We discuss scope, design considerations and technical and

  9. What Is "Good" Mentoring? Understanding Mentoring Practices of Teacher Induction through Case Studies of Finland and Australia

    ERIC Educational Resources Information Center

    Pennanen, Matti; Bristol, Laurette; Wilkinson, Jane; Heikkinen, Hannu L. T.

    2016-01-01

    Mentoring is a practice widely utilised to support new teachers. However, in locally formed systems, the practice of mentoring is conditioned by traditions and arrangements specific to the site. To understand "good" mentoring, these local arrangements cannot be ignored. In this article, the theory of practice architectures is employed to…

  10. Injectable opiate maintenance in the UK: Is it good clinical practice?

    PubMed

    Zador, D

    2001-04-01

    This paper reviews the current practice of injectable opiate treatment (IOT) in the United Kingdom, i.e. the "British system" of prescribing injectable heroin and methadone, and considers some of the clinical and ethical issues it raises. There is very limited research evidence supporting either the safety or effectiveness of IOT as practised in Britain. In particular there is almost no evaluation of long-term outcomes of IOT, which is of potential concern given the possibility of some patients remaining indefinitely in IOT, the risk of vascular complications, and its higher cost compared with oral maintenance. It would be easy to assess this controversial intervention as in need of further research. However, striving towards best practice in IOT involves more than generating evidence. The likelihood of a patient receiving IOT in the United Kingdom appears to be influenced more by the personal inclinations of prescribers than by outcome data (if any), or identified community needs for access to IOT. The author asks is this good clinical practice and is it sustainable? The "British system" needs to modernise itself consistent with international paradigms of continuous quality improvement, and the NHS's own agenda of clinical governance. PMID:11300958

  11. Identity, emotion and the internal goods of practice: a study of learning disability professionals.

    PubMed

    Fisher, Pamela; Byrne, Victoria

    2012-01-01

    Contemporary transitions in the delivery of health and social care are a global phenomenon. They prompt a particular need to reconsider how quality in relation to professional practice should be understood and whether greater importance should be attached to values such as goodwill, altruism and commitment. Based on a qualitative study of a small voluntary sector organisation in the North of England, this paper addresses how changes in policy articulate with the identities of professionals who work in learning disability services. Drawing on MacIntyre's After Virtue, which is discussed in relation to some recent sociological debates on emotion, it is suggested that professionals have an emotionally based commitment to their work as well as to the people they work with. Professional commitment is embedded in a coherent sense of self that problematises traditional binaries between the private and the public, and the cognitive and affective. The participants in this study appeared to pursue what MacIntyre terms the 'internal goods' of practice; they valued being able to work innovatively and responsively with service users. It is suggested that this requires a particular type of relationship with oneself, with others, and with practice, which engenders a criticality towards dominant professional discourses. PMID:21668456

  12. A checklist for health research priority setting: nine common themes of good practice

    PubMed Central

    2010-01-01

    Health research priority setting processes assist researchers and policymakers in effectively targeting research that has the greatest potential public health benefit. Many different approaches to health research prioritization exist, but there is no agreement on what might constitute best practice. Moreover, because of the many different contexts for which priorities can be set, attempting to produce one best practice is in fact not appropriate, as the optimal approach varies per exercise. Therefore, following a literature review and an analysis of health research priority setting exercises that were organized or coordinated by the World Health Organization since 2005, we propose a checklist for health research priority setting that allows for informed choices on different approaches and outlines nine common themes of good practice. It is intended to provide generic assistance for planning health research prioritization processes. The checklist explains what needs to be clarified in order to establish the context for which priorities are set; it reviews available approaches to health research priority setting; it offers discussions on stakeholder participation and information gathering; it sets out options for use of criteria and different methods for deciding upon priorities; and it emphasizes the importance of well-planned implementation, evaluation and transparency. PMID:21159163

  13. Good clinical practice: a nuisance, a help or a necessity for clinical pharmacology?

    PubMed Central

    Sweatman, John

    2003-01-01

    This article reviews the impact of good clinical practice (GCP) on clinical pharmacology with particular reference to the new European Union Clinical Trial Directive. The Directive will be applied to both commercial and noncommercial studies on medicinal products for human use. The Directive requires that GCP should be used in all clinical trials except noninterventional studies. GCP is likely to follow the International Conference on Harmonization GCP guidelines in many aspects. GCP will enforce tighter guidelines on ethical aspects of a clinical study. Higher standards will be required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities including computers. Quality assurance and inspections will ensure that these standards are achieved. The additional requirements of GCP are discussed and any advantage to the study subject. The impact of the new Directive within the Research Governance Framework of the UK Department of Health is reviewed. PMID:12534634

  14. Community learning disability teams: developments, composition and good practice: a review of the literature.

    PubMed

    Slevin, Eamonn; Truesdale-Kennedy, Maria; McConkey, Roy; Barr, Owen; Taggart, Laurence

    2008-03-01

    This article presents the findings from a literature review related to community learning disability teams (CLDTs). Much of the existing literature on CLDTs is inspirational, theoretical or opinion based rather than evidence based. It was considered that current knowledge is insufficient to allow a systematic review; therefore a structured review of factors that impact on CLDTs was undertaken following some of the principles of a systematic review. The review covers historical and philosophical influences on the development of CLDTs; the structure and common composition of CLDTs; the main challenges facing CLDTs; and the barriers that impact on their effective working. Based on the available evidence a number of good practice suggestions are forwarded that have the potential to enhance the work undertaken by CLDTs, but it is acknowledged that there is a need for more research into the effectiveness of these teams. PMID:18337302

  15. Model of good practice tools for risk reduction and clinical governance.

    PubMed

    Smagghe, D; Segers, M; Spy-Anderson, P-J; Benamou, N; Eddabbeh, N

    2005-01-01

    Information and Communication Technologies (ICT) are expected to support Healthcare Professionals in reducing medical errors, making the most relevant decisions and finding the most appropriate procedure for each patient. In particular, Knowledge Management and Decision Support Systems provide access to high quality information and to appropriate protocols. The present paper aims at comparing the approaches used in three ongoing R&D projects in order to support risk reduction and clinical governance. This comparison will lead to the presentation of a generic model of Decision Support Tools that transform shared and documented "Good Practices" into software entities that can pro-actively advice users in their daily work or when they encounter difficult situations. PMID:15923768

  16. Vaccine industry perspective of current issues of good manufacturing practices regarding product inspections and stability testing.

    PubMed

    Monahan, T R

    2001-12-15

    I address 2 important topics of current good manufacturing practices as they apply to vaccine products: product inspections and stability testing. The perspective presented is that of regulated industry. There are 2 major categories of product/facility inspections: those occurring before licensure of a vaccine product and those occurring after a vaccine product is licensed. The logistics and focus of each inspection type, the preapproval inspection, and the required biennial inspection are discussed, as are guidance and recommendations for achieving successful inspections. The requirements, guidance, and recommendations regarding the type, amount, and extensiveness of stability data for vaccine products are presented. The discussion details the potential differences in the amount and type of data required for products that are not yet licensed versus marketed products. Guidance, from a regulated industry perspective, regarding the design and implementation of a successful stability program is also discussed. PMID:11709773

  17. Guide to good practices for continuing training. [Contains a decision tree for training

    SciTech Connect

    Not Available

    1993-02-01

    The purpose of this Guide to Good Practices for Continuing Training is to provide contractor training organizations with information and methods useful in the development and implementation of a continuing training program. DOE Order 5480.18A, Accreditation of Performance-Based Training for Category A Reactors and Nuclear Facilities,'' and DOE Order 5480.20, Personnel Selection, Qualification and Training Requirements at DOE Reactor and Non-reactor Nuclear Facilities'' Chapter 1, Paragraph 7, require each facility to design and implement a continuing training program. Continuing training is necessary to ensure that facility personnel continually improve their ability to operate and maintain their facility in a safe and reliable manner. Continuing training also should enhance the professionalism of these individuals and should make them aware of the possible consequences of misoperation.

  18. DOE handbook: Guide to good practices for the selection, training, and qualification of shift supervisors

    SciTech Connect

    1999-04-01

    This Department of Energy (DOE) handbook is approved for use by all DOE Components and their contractors. The Handbook incorporates editorial changes to DOE-STD-1061-93, ``Guide to Good Practices for the Selection, Training, and Qualification of shift Supervisors,`` and supersedes DOE-STD-1061-93. Technical content of this Handbook has not changed from the original technical standard. Changes are primarily editorial improvements, redesignation of the standard to a Handbook, and format changes to conform with current Technical Standards Program procedures. This guide, used in conjunction with a facility-specific job analysis, provides a framework for the selection, training, qualification, and professional development of reactor facility and non-reactor nuclear facility shift supervisors. Training and qualification programs based on this guide should provide assurance that shift supervisors perform their jobs safely and competently.

  19. Good modelling practice in applying computational fluid dynamics for WWTP modelling.

    PubMed

    Wicklein, Edward; Batstone, Damien J; Ducoste, Joel; Laurent, Julien; Griborio, Alonso; Wicks, Jim; Saunders, Stephen; Samstag, Randal; Potier, Olivier; Nopens, Ingmar

    2016-01-01

    Computational fluid dynamics (CFD) modelling in the wastewater treatment (WWT) field is continuing to grow and be used to solve increasingly complex problems. However, the future of CFD models and their value to the wastewater field are a function of their proper application and knowledge of their limits. As has been established for other types of wastewater modelling (i.e. biokinetic models), it is timely to define a good modelling practice (GMP) for wastewater CFD applications. An International Water Association (IWA) working group has been formed to investigate a variety of issues and challenges related to CFD modelling in water and WWT. This paper summarizes the recommendations for GMP of the IWA working group on CFD. The paper provides an overview of GMP and, though it is written for the wastewater application, is based on general CFD procedures. A forthcoming companion paper to provide specific details on modelling of individual wastewater components forms the next step of the working group. PMID:26942517

  20. Therapist Adherence to Good Psychiatric Practice in a Short-Term Treatment for Borderline Personality Disorder.

    PubMed

    Kolly, Stéphane; Despland, Jean-Nicolas; de Roten, Yves; Marquet, Pierre; Kramer, Ueli

    2016-07-01

    Therapist adherence describes the quality of interventions according to the imperatives of a treatment model. We examined the relationship between therapist adherence and symptom change in the context of a short-term treatment with respect good psychiatric management (GPM) principles. Based on a parent trial, borderline personality disorder patients (N = 40) benefited from a 10-session intervention. Adherence to GPM was assessed using a GPM Adherence Scale (GPMAS). The psychometric properties of the GPMAS were excellent, and the adherence to GPM explained 16% of the general symptom improvement (t(1) = 2.38, β = 0.40, p = 0.02) and 23% of the borderline symptom improvement (t(1) = 2.46, β = 0.48, p = 0.02). Because GPM adherence predicts the outcome after only 10 sessions, GPMAS is a valuable measure early on in psychiatric practice as part of an initial step to longer-term treatment, to quickly detect problems and correct them. PMID:27187770

  1. Good clinical practice is now obligatory in academic clinical drug research in the European Union.

    PubMed

    Jørgensen, Annette; Bach, Karin Friis; Friis, Karen

    2004-02-01

    By May 2004, all clinical trials in the European Union (EU) on medicinal products have to be initiated and conducted in compliance with the principles in the new directive on Good Clinical Practice (GCP). This requirement will also apply to non-commercial trials involving registered drugs and may therefore restrain the academic clinical drug research. In Denmark, three public GCP units connected in a national network and associated with the university hospitals in Copenhagen, Odense and Aarhus have been established. The GCP units offer academic researchers the necessary quality assurance and quality control systems to ensure that clinical drug research can be performed according to GCP. The Danish initiative is presented here as a contribution to the future work with implementation of the principles of GCP in academic clinical drug research in the European Union. PMID:14748847

  2. Japanese consumer preferences for milk certified with the good agricultural practice(GAP) label.

    PubMed

    Aizaki, Hideo; Nanseki, Teruaki; Zhou, Hui

    2013-01-01

    This study examined Japanese consumers' valuation of a good agricultural practice (GAP) label on packaged milk and investigated the effect of detailed GAP information on valuation. A total of 624 Japanese consumers were asked to select their most preferred milk through an online survey. The milk was assumed to have three attributes: the GAP label, Hazard Analysis and Critical Control Points certification, and price. The results showed that consumers' valuation of GAP was significantly positive. Although providing additional GAP information to a respondent who was aware of GAP and what it means had a positive effect on the consumers' valuation of GAP, provision of this information had no effect if the respondent knew about GAP either moderately or slightly, and had a negative effect if the respondent did not know about GAP at all. To increase broad consumer awareness and valuation of GAP, it is important to provide GAP information according to the requirements of consumers. PMID:23302087

  3. Current issues of personnel and laboratory practices in genetic testing

    PubMed Central

    Mark, Hon Fong Louie; Kelly, Thaddeus; Watson, Michael S; Hoeltge, Gerald; Miller, Wayne A; Beauregard, Laurent

    1995-01-01

    As genetic testing is an area with implications extending far beyond that of the primary patient, it is appropriately an area that is under increased scrutiny. To ensure that high quality is maintained in the delivery of genetic services, several agencies have developed standards and guidelines. The present article summarises important recommendations made by the American College of Medical Genetics (ACMG), the College of American Pathologists (CAP), the US Health Care Financing Administration (HCFA), and the US Food and Drug Administration (FDA) as they relate to genetic testing. Some of the standards are based on voluntary compliance, whereas others have the force of regulation. They all address issues of personnel credentials, laboratory operations, and the most critical quality assurance and control measures for diagnostic laboratories from the perspective of various agencies. In most instances, the standards promulgated by these agencies are offered as minimum criteria. The exact impact of these regulations on the practice of medical genetics has yet to be established. Images PMID:8558555

  4. [Teaching design and practice of human blood type traits in genetics comprehensive laboratory course].

    PubMed

    Zhao, Jian; Hu, Dongmei; Yu, Dade; Dong, Mingliang; Li, Yun; Fan, Yingming; Wang, Yanwei; Zhang, Jinfeng

    2016-05-01

    Comprehensive laboratory courses, which enable students to aptly apply theoretic knowledge and master experiment skills, play an important role in the present educational reform of laboratory courses. We utilized human ABO blood type as the experimental subject, and designed the experiment--"Molecular Genotyping of Human ABO Blood Type and Analysis of Population Genetic Equilibrium". In the experiment, DNA in mucosal cells is extracted from students' saliva, and each student's genotype is identified using a series of molecular genetics technologies, including PCR amplification of target fragments, enzymatic digestion, and electrophoretic separation. Then, taking the whole class as an analogous Mendel population, a survey of genotype frequency of ABO blood type is conducted, followed with analyses of various population genetic parameters using Popgene. Through the open laboratory course, students can not only master molecular genetic experimental skills, but also improve their understanding of theoretic knowledge through independent design and optimization of molecular techniques. After five years of research and practice, a stable experimental system of molecular genetics has been established to identify six genotypes of ABO blood types, namely I(A)I(A), I(A)i, I(B)I(B), I(B)i, I(A)I(B) and ii. Laboratory courses of molecular and population genetics have been integrated by calculating the frequencies of the six genotypes and three multiple alleles and testing population genetic equilibrium. The goal of the open laboratory course with independent design and implementation by the students has been achieved. This laboratory course has proved effective and received good reviews from the students. It could be applied as a genetics laboratory course for the biology majors directly, and its ideas and methods could be promoted and applied to other biological laboratory courses. PMID:27232494

  5. From Skin Biopsy to Neurons Through a Pluripotent Intermediate Under Good Manufacturing Practice Protocols

    PubMed Central

    Karumbayaram, Saravanan; Lee, Peiyee; Azghadi, Soheila F.; Cooper, Aaron R.; Patterson, Michaela; Kohn, Donald B.; Pyle, April; Clark, Amander; Byrne, James; Zack, Jerome A.; Plath, Kathrin

    2012-01-01

    The clinical application of human-induced pluripotent stem cells (hiPSCs) requires not only the production of Good Manufacturing Practice-grade (GMP-grade) hiPSCs but also the derivation of specified cell types for transplantation under GMP conditions. Previous reports have suggested that hiPSCs can be produced in the absence of animal-derived reagents (xenobiotics) to ease the transition to production under GMP standards. However, to facilitate the use of hiPSCs in cell-based therapeutics, their progeny should be produced not only in the absence of xenobiotics but also under GMP conditions requiring extensive standardization of protocols, documentation, and reproducibility of methods and product. Here, we present a successful framework to produce GMP-grade derivatives of hiPSCs that are free of xenobiotic exposure from the collection of patient fibroblasts, through reprogramming, maintenance of hiPSCs, identification of reprogramming vector integration sites (nrLAM-PCR), and finally specification and terminal differentiation of clinically relevant cells. Furthermore, we developed a primary set of Standard Operating Procedures for the GMP-grade derivation and differentiation of these cells as a resource to facilitate widespread adoption of these practices. PMID:23197638

  6. Good manufacturing practice (GMP) compliance in the biologics sector: plasma fractionation.

    PubMed

    Ways, J P; Preston, M S; Baker, D; Huxsoll, J; Bablak, J

    1999-12-01

    The U.S. blood supply is the safest it has ever been. Due to blood safety and the introduction of viral inactivation/clearance technologies, protein therapies derived from human blood have also in recent years had a history of product safety. Nevertheless, since 1995, the plasma-fractionation industry has experienced increased compliance-related actions by the Food and Drug Administration (FDA), as shown by a substantive increase in the number of FDA 483 inspectional observations, FDA warning letters and other FDA regulatory action. An evaluation of these trends shows that they reflect the implementation by the FDA of increased inspectional interest in the plasma-fractionation industry and an evolution of inspectional practices and standards of current good manufacturing practice (cGMP). Plasma fractionators have responded to FDA actions by carefully evaluating and addressing each inspectional observation, assessing impact to product and taking appropriate actions, including corrective actions to prevent future occurrence. They have made major investments in facilities, quality systems, personnel and training to meet the evolving standards of cGMP and in an effort to implement these standards systemically. Through industry associations, manufacturers have further enhanced product safety by adopting additional voluntary standards for plasma to prevent the entry of potentially unsuitable plasma into the production process. The industry remains committed to application of cGMP and to working with the FDA in further evolution of these standards while striving to assure a continued supply of safe, pure and effective plasma-derived therapies. PMID:10574696

  7. Good clinical practice guidelines for care home residents with diabetes: an executive summary.

    PubMed

    Sinclair, A J

    2011-07-01

    A Task and Finish Group of Diabetes UK was convened over 14 months to undertake a systematic review of the original 1999 British Diabetic Association guidance on care home diabetes, incorporate new research findings and produce a set of recommendations that are evidenced-based, practical and implementable within UK care home settings. The anticipation of Diabetes UK is that these guidelines will represent a national policy of good clinical practice for diabetes care within care homes. This executive summary demonstrates how the full guidelines should provide a framework of assessment of the quality of diabetes care within care homes, for use by regulatory bodies who have responsibility for this provision of diabetes care. This document is primarily based on recommendations for adults living within British care home environments and its focus, by virtue of the nature and characteristics of residents, is on older adults. Improvements in diabetes care within residential and nursing homes are likely to follow a sustained commitment by health and social care professionals to ensure that the well-being of residents with diabetes is paramount, that high-quality policies of diabetes care are implemented and monitored and effective diabetes education is a mandatory and integral part of care home staff training. PMID:21672001

  8. Development and implementation of the Good Neighbor Agreement (GNA) practice in the USA sustainable mining development.

    NASA Astrophysics Data System (ADS)

    Masaitis, Alexandra

    2014-05-01

    New economic, environmental and social challenges for the mining industry in the USA show the need to implement "responsible" mining practices that include improved community involvement. Conflicts which occur in the US territory and with US mining companies around the world are now common between the mining proponents, NGO's and communities. These conflicts can sometimes be alleviated by early development of modes of communication, and a formal discussion format that allows airing of concerns and potential resolution of problems. One of the methods that can formalize this process is to establish a Good Neighbor Agreement (GNA), which deals specifically with challenges in relationships between mining operations and the local communities. It is a new practice related to mining operations that are oriented toward social needs and concerns of local communities that arise during the normal life of a mine, which can achieve sustainable mining practices. The GNA project being currently developed at the University of Nevada, USA in cooperation with the Newmont Mining Corporation has a goal of creating an open company/community dialog that will help identify and address sociological and environmental concerns associated with mining. Discussion: The Good Neighbor Agreement currently evolving will address the following: 1. Identify spheres of possible cooperation between mining companies, government organizations, and NGO's. 2. Provide an economically viable mechanism for developing a partnership between mining operations and the local communities that will increase mining industry's accountability and provide higher levels of confidence for the community that a mine is operated in a safe and sustainable manner. Implementation of the GNA can help identify and evaluate conflict criteria in mining/community relationships; determine the status of concerns; determine the role and responsibilities of stakeholders; analyze problem resolution feasibility; maintain the community

  9. Laboratories for the 21st Century: Best Practices; Energy Recovery in Laboratory Facilities (Brochure)

    SciTech Connect

    Not Available

    2012-06-01

    This guide regarding energy recovery is one in a series on best practices for laboratories. It was produced by Laboratories for the 21st Century ('Labs 21'), a joint program of the U.S. Environmental Protection Agency and the U.S. Department of Energy. Laboratories typically require 100% outside air for ventilation at higher rates than other commercial buildings. Minimum ventilation is typically provided at air change per hour (ACH) rates in accordance with codes and adopted design standards including Occupational Safety and Health Administration (OSHA) Standard 1910.1450 (4 to 12 ACH - non-mandatory) or the 2011 American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) Applications Handbook, Chapter 16 - Laboratories (6 to 12 ACH). While OSHA states this minimum ventilation rate 'should not be relied on for protection from toxic substances released into the laboratory' it specifically indicates that it is intended to 'provide a source of air for breathing and for input to local ventilation devices (e.g., chemical fume hoods or exhausted bio-safety cabinets), to ensure that laboratory air is continually replaced preventing the increase of air concentrations of toxic substances during the working day, direct air flow into the laboratory from non-laboratory areas and out to the exterior of the building.' The heating and cooling energy needed to condition and move this outside air can be 5 to 10 times greater than the amount of energy used in most office buildings. In addition, when the required ventilation rate exceeds the airflow needed to meet the cooling load in low-load laboratories, additional heating energy may be expended to reheat dehumidified supply air from the supply air condition to prevent over cooling. In addition to these low-load laboratories, reheat may also be required in adjacent spaces such as corridors that provide makeup air to replace air being pulled into negative-pressure laboratories. Various types of energy recovery

  10. The procurement of cells for the derivation of human embryonic stem cell lines for therapeutic use: recommendations for good practice.

    PubMed

    Murdoch, Alison; Braude, Peter; Courtney, Aidan; Brison, Daniel; Hunt, Charles; Lawford-Davies, James; Moore, Harry; Stacey, Glyn; Sethe, Sebastian

    2012-03-01

    The donation of human embryos for the derivation of embryonic stem cell lines that may be used in the development of therapeutic products raises more complex ethical, practical and regulatory problems than the donation of embryos for non-clinical research. This review considers these issues and offers recommendations for good practice. PMID:21671059

  11. Alternatives to Laboratory Practicals - Do They Meet the Needs?

    ERIC Educational Resources Information Center

    Hughes, Ian E.

    2001-01-01

    Compares the academic performance of students exposed to either "wet" practical classes or "simulated" practicals. Assessed practical write-ups from pharmacology students using a simulation showed a mark significantly better than those doing the "wet" practical. Simulations can provide an aid to learning which is as effective as "wet" practicals,…

  12. Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention.

    PubMed

    Goedecke, Thomas; Ord, Kathryn; Newbould, Victoria; Brosch, Sabine; Arlett, Peter

    2016-06-01

    A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Reducing the risk of medication errors is a shared responsibility between patients, healthcare professionals, regulators and the pharmaceutical industry at all levels of healthcare delivery. In 2015, the EU regulatory network released a two-part good practice guide on medication errors to support both the pharmaceutical industry and regulators in the implementation of the changes introduced with the EU pharmacovigilance legislation. These changes included a modification of the 'adverse reaction' definition to include events associated with medication errors, and the requirement for national competent authorities responsible for pharmacovigilance in EU Member States to collaborate and exchange information on medication errors resulting in harm with national patient safety organisations. To facilitate reporting and learning from medication errors, a clear distinction has been made in the guidance between medication errors resulting in adverse reactions, medication errors without harm, intercepted medication errors and potential errors. This distinction is supported by an enhanced MedDRA(®) terminology that allows for coding all stages of the medication use process where the error occurred in addition to any clinical consequences. To better understand the causes and contributing factors, individual case safety reports involving an error should be followed-up with the primary reporter to gather information relevant for the conduct of root cause analysis where this may be appropriate. Such reports should also be summarised in periodic safety update reports and addressed in risk management plans. Any risk minimisation and prevention strategy for medication errors should consider all stages of a medicinal product's life-cycle, particularly the main sources and types of medication errors during product development. This article

  13. The Good Behavior Game: a best practice candidate as a universal behavioral vaccine.

    PubMed

    Embry, Dennis D

    2002-12-01

    A "behavioral vaccine" provides an inoculation against morbidity or mortality, impacting physical, mental, or behavior disorders. An historical example of a behavioral vaccine is antiseptic hand washing to reduce childbed fever. In current society, issues with high levels of morbidity, such as substance abuse, delinquency, youth violence, and other behavioral disorders (multiproblems), cry out for a low-cost, widespread strategy as simple as antiseptic hand washing. Congruent research findings from longitudinal studies, twin studies, and other investigations suggest that a possibility might exist for a behavioral vaccine for multiproblem behavior. A simple behavioral strategy called the Good Behavior Game (GBG), which reinforces inhibition in a group context of elementary school, has substantial previous research to consider its use as a behavioral vaccine. The GBG is not a curriculum but rather a simple behavioral procedure from applied behavior analysis. Approximately 20 independent replications of the GBG across different grade levels, different types of students, different settings, and some with long-term follow-up show strong, consistent impact on impulsive, disruptive behaviors of children and teens as well as reductions in substance use or serious antisocial behaviors. The GBG, named as a "best practice" for the prevention of substance abuse or violent behavior by a number of federal agencies, is unique because it is the only practice implemented by individual teachers that is documented to have long-term effects. Presently, the GBG is only used in a small number of settings. However, near universal use of the GBG, in major political jurisdictions during the elementary years, could substantially reduce the incidence of substance use, antisocial behavior, and other adverse developmental or social consequences at a very modest cost, with very positive cost-effectiveness ratios. PMID:12495270

  14. [Psychometric properties of an instrument to evaluate the nurse attitude towards good practice guides].

    PubMed

    López-Díaz, Cristina; Fraille-Calle, Luis; Herrero-Rosado, Marta; Arnés-Muñoz, Vanessa; De-Dios-De-Dios, Teresa

    2016-01-01

    The Guides of Good Practices (GGP) are necessary tools in the universal healthcare and in the clinical management, providing the user/patient with a major quality in the assistance, in order to optimize and reinforce an individualized attention into action, taking into account the best scientific evidence. The literature provides different references to the development of the GGP, but there is little knowledge about the attitude of professionals towards them, since most of the studies that exist are qualitative. Therefore, the aim of this work is to construct and validate a Likert scale which could assess the attitude of the nurse towards GGP. The methodology used was quantitative, descriptive, cross, opinion, anonymous and also it could validate a scale via the following measurements: content validation by experts, correlation between items, external reliability, internal consistency, stability and exploratory factor analysis. The result was a scale consisting of 20 items that refer to the attitude toward the GGP, with a percentage of agreement among experts over 75 % on all the items, and a significant Pearson correlation between the pre-test and post-test in all variables, but for three. The internal consistency measured by Cronbach's alpha was 0.878. These results are acceptable in terms of the psychometric characteristics of the instrument, with easy and fast administration and simple in their interpretation, allowing quantifying and generating knowledge about the attitudes of nurses towards GGP. PMID:26996039

  15. Good publication practices in clinical pharmacology: transparency, evidence-based medicine and the 7-D assessment*

    PubMed Central

    Woodcock, Barry G.; Luger, Veronika

    2015-01-01

    Transparency and evidence-based medicine are cornerstones of good publication practices (GPP), and concern publishers, editors, research investigators, and reviewers alike. Methods for implementing these principles within the framework of GPP are described. The main aspects include obtaining a Manuscript Agreement Contract, a Statement on Transparency of Authorship and a Declaration of Conflicts of Interest from the authors. Assessing whether a manuscript meets the requirements of EBM is demonstrated using the “7-D assessment”. The main purpose of this tool is to established that the (1) right Design, (2) right Diagnosis, (3) right Drug molecule, (4) right Dosage, (5) right Data, (6) right Deductions, and (7) right Documentation have been implemented in order to meet the objectives of the investigation. If the findings from any one of these assessments is questionable, the compliance of the research with EBM principles will be weakened and the reviewers and editors will make recommendations to the publisher accordingly. The guidelines described will help to provide a fair and transparent process of scientific publication and foster the freedom of clinical pharmacological research. PMID:26329349

  16. Making abortions safe: a matter of good public health policy and practice.

    PubMed Central

    Berer, M.

    2000-01-01

    Globally, abortion mortality accounts for at least 13% of all maternal mortality. Unsafe abortion procedures, untrained abortion providers, restrictive abortion laws and high mortality and morbidity from abortion tend to occur together. Preventing mortality and morbidity from abortion in countries where these remain high is a matter of good public health policy and medical practice, and constitutes an important part of safe motherhood initiatives. This article examines the changes in policy and health service provision required to make abortions safe. It is based on a wide-ranging review of published and unpublished sources. In order to be effective, public health measures must take into account the reasons why women have abortions, the kind of abortion services required and at what stages of pregnancy, the types of abortion service providers needed, and training, cost and counselling issues. The transition from unsafe to safe abortions demands the following: changes at national policy level; abortion training for service providers and the provision of services at the appropriate primary level health service delivery points; and ensuring that women access these services instead of those of untrained providers. Public awareness that abortion services are available is a crucial element of this transition, particularly among adolescent and single women, who tend to have less access to reproductive health services generally. PMID:10859852

  17. Guide to good practices for the design, development, and implementation of examinations

    SciTech Connect

    1997-06-01

    The purpose of this Guide to Good Practices is to provide direction to training personnel in the broad areas of design, development, and implementation of examinations. Nuclear facilities spend a significant amount of training resources testing trainees. Tests are used for employee selection, qualification, requalification, certification and recertification, and promotion. Ineffective testing procedures, or inappropriate interpretation of test results, can have significant effects on both human performance and facility operations. Test development requires unique skills, and as with any skill, training and experience are needed to develop the skills. Test development, test use, test result interpretation, and test refinement, like all other aspects of the systematic approach to training, should be part of an ongoing, systematic process. For some users this document will provide a review of ideas and principles with which they are already familiar; for others it will present new concepts. While not intended to provide in-depth coverage of test theory design and development, it should provide developers, instructors, and evaluators with a foundation on which to develop sound examinations.

  18. Production of mesenchymal stromal/stem cells according to good manufacturing practices: a review.

    PubMed

    Sensebé, Luc; Gadelorge, Mélanie; Fleury-Cappellesso, Sandrine

    2013-01-01

    Because of their multi/pluripotency and immunosuppressive properties, mesenchymal stem/stromal cells (MSCs) are important tools for treating immune disorders and for tissue repair. The increasing use of MSCs, their definition as advanced-therapy medicinal products in European regulations, and the US Food and Drug Administration requirements for their production and use imply the use of production processes that should be in accordance with Good Manufacturing Practices (GMPs). Complying with GMPs requires precisely defining the production process (es) as well as the multiple criteria required for a quality final product. Such variables include the environment, staff training and qualification, and controls. Developing processes based on well-defined or completely defined media and operating in closed systems or bioreactors is important and will increase safety and reproducibility. One of the most challenging issues remains implementation of relevant and reproducible controls for safety and efficacy. A linking of researchers, research and development teams, producers, and clinicians is mandatory to achieve GMP-compliant processes with relevant controls for producing well-defined, safe, and efficient MSCs. PMID:23751270

  19. [Qualitative evaluation of employer requirements associated with occupational health and safety as good practice in small-scale enterprises].

    PubMed

    Kuroki, Naomi; Miyashita, Nana; Hino, Yoshiyuki; Kayashima, Kotaro; Fujino, Yoshihisa; Takada, Mikio; Nagata, Tomohisa; Yamataki, Hajime; Sakuragi, Sonoko; Kan, Hirohiko; Morita, Tetsuya; Ito, Akiyoshi; Mori, Koji

    2009-09-01

    The purpose of this study was to identify what motivates employers to promote good occupational health and safety practices in small-scale enterprises. Previous studies have shown that small-scale enterprises generally pay insufficient attention to issues of occupational health and safety. These findings were mainly derived from questionnaire based surveys. Nevertheless, some small-scale enterprises in which employers exercise good leadership do take a progressive approach to occupational health and safety. Although good practices can be identified in small-scale enterprises, it remains unclear what motivates employers in small-scale enterprises to actively implement occupational health and safety practices. We speculated that identifying employer motivations in promoting occupational health would help to spread good practices among small-scale enterprises. Using a qualitative approach based on the KJ methods, we interviewed ten employers who actively promote occupational health and safety in the workplace. The employers were asked to discuss their views of occupational health and safety in their own words. A semi-structured interview format was used, and transcripts were made of the interviews. Each transcript was independently coded by two or more researchers. These transcripts and codes were integrated and then the research group members discussed the heading titles and structural relationships between them according to the KJ method. Qualitative analysis revealed that all the employers expressed a strong interest in a "good company" and "good management". They emphasized four elements of "good management", namely "securing human resources", "trust of business partners", "social responsibility" and "employer's health condition itself", and considered that addressing occupational health and safety was essential to the achievement of these four elements. Consistent with previous findings, the results showed that implementation of occupational health and safety

  20. Examples of Holistic Good Practices in Promoting and Protecting Mental Health in the Workplace: Current and Future Challenges

    PubMed Central

    Sivris, Kelly C.; Leka, Stavroula

    2015-01-01

    Background While attention has been paid to physical risks in the work environment and the promotion of individual employee health, mental health protection and promotion have received much less focus. Psychosocial risk management has not yet been fully incorporated in such efforts. This paper presents good practices in promoting mental health in the workplace in line with World Health Organization (WHO) guidance by identifying barriers, opportunities, and the way forward in this area. Methods Semistructured interviews were conducted with 17 experts who were selected on the basis of their knowledge and expertise in relation to good practice identified tools. Interviewees were asked to evaluate the approaches on the basis of the WHO model for healthy workplaces. Results The examples of good practice for Workplace Mental Health Promotion (WMHP) are in line with the principles and the five keys of the WHO model. They support the third objective of the WHO comprehensive mental health action plan 2013–2020 for multisectoral implementation of WMHP strategies. Examples of good practice include the engagement of all stakeholders and representatives, science-driven practice, dissemination of good practice, continual improvement, and evaluation. Actions to inform policies/legislation, promote education on psychosocial risks, and provide better evidence were suggested for higher WMHP success. Conclusion The study identified commonalities in good practice approaches in different countries and stressed the importance of a strong policy and enforcement framework as well as organizational responsibility for WMHP. For progress to be achieved in this area, a holistic and multidisciplinary approach was unanimously suggested as a way to successful implementation. PMID:26929841

  1. [Good agricultural practice (GAP) of Chinese materia medica (CMM) for ten years: achievements, problems and proposals].

    PubMed

    Guo, Lan-Ping; Zhang, Yan; Zhu, Shou-Dong; Wang, Gui-Hua; Wang, Xiu; Zhang, Xiao-Bo; Chen, Mei-Lan; He, Ya-Li; Han, Bang-Xing; Chen, Nai-Fu; Huang, Lu-Qi

    2014-04-01

    This paper aims to summarize the achievements during the implementation process of good agricultural practice (GAP) in Chinese Materia Medica (CMM), and on basis of analyzing the existing problems of GAP, to propose further implementation of GAP in TCM growing. Since the launch of GAP in CMM growing ten years ago, it has acquired great achievements, including: (1) The promulgation of a series of measures for the administration of the GAP approval in the CMM growing; (2) The expanded planting area of CMM; (3) The increased awareness of standardized CMM growing among farmers and enterprises; (4) The establishment of GAP implementation bases for CMM growing; (5) The improvement of theory and methodology for CMM growing; (6) The development of a large group of experts and scholars in GAP approval for CMM production. The problems existing in the production include: (1) A deep understanding of GAP and its certification is still needed; (2) The distribution of the certification base is not reasonable; (3) The geo-economics effect and the backward farming practices are thought to be the bottlenecks in the standardization of CMM growing and the scale production of CMM; (4) Low comparative effectiveness limits the development of the GAP; (5) The base of breeding improved variety is blank; (6) The immature of the cultivation technique lead to the risk of production process; (7) The degradation of soil microbial and the continuous cropping obstacle restrict the sustainable development of the GAP base. To further promote the health and orderly GAP in the CMM growing, the authors propose: (1) To change the mode of production; (2) To establish a sound standard system so as to ensure quality products for fair prices; (3) To fully consider the geo-economic culture and vigorously promote the definite cultivating of traditional Chinese medicinal materials; (4) To strengthen the transformation and generalization of basic researches and achievements, in order to provide technical

  2. Clinical trials and the new good clinical practice guideline in Japan. An economic perspective.

    PubMed

    Ono, S; Kodama, Y

    2000-08-01

    Japanese clinical trials have been drastically changing in response to the implementation of the International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guideline in 1997. The most important aim of the new guideline is to standardise the quality of clinical trials in the US, European Union and Japan, but it inevitably imposes substantial costs on investigators, sponsors and even patients in Japan. The study environment in Japan differs from that in the US in several ways: (i) historical lack of a formal requirement for informed consent; (ii) patients' attitudes to clinical trials in terms of expectation of positive outcomes; (iii) the implications of universal health insurance for trial participation; (iv) the historical absence of on-site monitoring by the sponsor, with the attendant effects on study quality; and (v) the lack of adequate financial and personnel support for the conduct of trials. Implementation of the new GCP guideline will improve the ethical and scientific quality of trials conducted in Japan. It may also lead to an improved relationship between medical professionals and patients if the requirement for explicit informed consent in clinical trials leads to the provision of a similar level of patient information in routine care and changes the traditional paternalistic attitude of physicians to patients. The initial response of the Japanese 'market' for clinical trials to the implementation of the ICH-GCP guideline has been clinical trial price increases and a decrease in the number of study contracts. These changes can be explained by applying a simple demand-supply scheme. Whether clinical trials undertaken in Japan become more or less attractive to the industry in the long term will depend on other factors such as international regulations on the acceptability of foreign clinical trials and the reform of domestic healthcare policies. PMID:11067647

  3. Good Cascade Impactor Practice (GCIP) and considerations for "in-use" specifications.

    PubMed

    Nichols, S C; Mitchell, J P; Shelton, C M; Roberts, D L

    2013-03-01

    The multi-stage cascade impactor (CI) is widely used to determine aerodynamic particle size distributions (APSDs) of orally inhaled products. Its size-fractionating capability depends primarily on the size of nozzles of each stage. Good Cascade Impactor Practice (GCIP) requires that these critical dimensions are linked to the accuracy of the APSD measurement based on the aerodynamic diameter size scale. Effective diameter (Deff) is the critical dimension describing any nozzle array, as it is directly related to stage cut-point size (d50). d50 can in turn be determined by calibration using particles of known aerodynamic diameter, providing traceability to the international length standard. Movements in Deff within manufacturer tolerances for compendial CIs result in the worst case in shifts in d50 of <±10%. Stage mensuration therefore provides satisfactory control of measurement accuracy. The accurate relationship of Deff to d50 requires the CI system to be leak-free, which can be checked by sealing the apparatus at the entry to the induction port and isolating it from the vacuum source and measuring the rate of pressure rise before each use. Mensuration takes place on an infrequent basis compared with the typical interval between individual APSD determinations. Measurement of stage flow resistance (pressure drop; ΔPstage) could enable the user to know that the CI stages are fit for use before every APSD measurement, by yielding an accurate measure of Deff. However, more data are needed to assess the effects of wear and blockage before this approach can be advocated as part of GCIP. PMID:23344853

  4. Improving consistency in large laboratory courses: a design for a standardized practical exam.

    PubMed

    Chen, Xinnian; Graesser, Donnasue; Sah, Megha

    2015-06-01

    Laboratory courses serve as important gateways to science, technology, engineering, and mathematics education. One of the challenges in assessing laboratory learning is to conduct meaningful and standardized practical exams, especially for large multisection laboratory courses. Laboratory practical exams in life sciences courses are frequently administered by asking students to move from station to station to answer questions, apply knowledge gained during laboratory experiments, interpret data, and identify various tissues and organs using various microscopic and gross specimens. This approach puts a stringent time limit on all questions regardless of the level of difficulty and also invariably increases the potential risk of cheating. To avoid potential cheating in laboratory courses with multiple sections, the setup for practical exams is often changed in some way between sections. In laboratory courses with multiple instructors or teaching assistants, practical exams may be handled inconsistently among different laboratory sections, due to differences in background knowledge, perceptions of the laboratory goals, or prior teaching experience. In this article, we describe a design for a laboratory practical exam that aims to align the assessment questions with well-defined laboratory learning objectives and improve the consistency among all laboratory sections. PMID:26031726

  5. Evolution of a Profession: The Importance of Education and Good Practice within Outward Bound.

    ERIC Educational Resources Information Center

    Gassner, Michael

    2002-01-01

    Outdoor adventure educators need a solid foundation in theoretical knowledge that will influence and guide equally important practical skills. A strong sense of professional practice should be instilled in new outdoor adventure educators to prevent them from becoming insulated in their ideas and practices. Philosophical underpinnings and good…

  6. Assessing Practical Laboratory Skills in Undergraduate Molecular Biology Courses

    ERIC Educational Resources Information Center

    Hunt, Lynne; Koenders, Annette; Gynnild, Vidar

    2012-01-01

    This study explored a new strategy of assessing laboratory skills in a molecular biology course to improve: student effort in preparation for and participation in laboratory work; valid evaluation of learning outcomes; and students' employment prospects through provision of evidence of their skills. Previously, assessment was based on written…

  7. 40 CFR 79.60 - Good laboratory practices (GLP) standards for inhalation exposure health effects testing.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... the CAA, it shall be a violation of this section and a violation of this rule (40 CFR part 79, subpart... under 40 CFR part 79 and may require the sponsor to develop data in accordance with the requirements of...) Where applicable, the number, body weight, sex, source of supply, species, strain, substrain, and age...

  8. 40 CFR 79.60 - Good laboratory practices (GLP) standards for inhalation exposure health effects testing.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the CAA, it shall be a violation of this section and a violation of this rule (40 CFR part 79, subpart... under 40 CFR part 79 and may require the sponsor to develop data in accordance with the requirements of... mutagenicity tests, wet specimens of blood, urine, feces, and biological fluids, do not need to be...

  9. 40 CFR 79.60 - Good laboratory practices (GLP) standards for inhalation exposure health effects testing.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... the CAA, it shall be a violation of this section and a violation of this rule (40 CFR part 79, subpart... under 40 CFR part 79 and may require the sponsor to develop data in accordance with the requirements of...) standards for inhalation exposure health effects testing. 79.60 Section 79.60 Protection of...

  10. 40 CFR 79.60 - Good laboratory practices (GLP) standards for inhalation exposure health effects testing.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... the CAA, it shall be a violation of this section and a violation of this rule (40 CFR part 79, subpart... under 40 CFR part 79 and may require the sponsor to develop data in accordance with the requirements of...) standards for inhalation exposure health effects testing. 79.60 Section 79.60 Protection of...

  11. 40 CFR 79.60 - Good laboratory practices (GLP) standards for inhalation exposure health effects testing.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... the CAA, it shall be a violation of this section and a violation of this rule (40 CFR part 79, subpart... under 40 CFR part 79 and may require the sponsor to develop data in accordance with the requirements of... determine the solubility of each reference substance in the carrier mixture before the experimental...

  12. [Good medical practice for drugs. Definition, guidelines, references, field of action and applications].

    PubMed

    2008-01-01

    Proper use of drugs can be defined as the use of the right product, in a correct dosage, during an adequate length of time, for a given patient and provided he has no serious side effects.It is virtually impossible, with such a number of drugs, such a number of clinical situations to prescribe adequately without using references or guidelines. References may lead to a unique choice, when the diagnosis is certain and the drug to be given is unique. With a good initial and continuous medical education, doctors can take easily this type of decision. The Summary of Products Characteristics (SPC) helps them; by sticking to this fundamental reference, prescription might be more precise and safe. In a lot of clinical situations the choice between a large numbers of therapeutic strategies necessitates use of a guideline based on scientific knowledge. Finally, a given therapeutic strategy can be as effective as and considerably less expensive than another. In such cases, payers can drive doctors to the prescription of the less expensive strategy.Some difficulties are common to all references and guidelines: 1. A lot of clinical situations are not covered by guidelines. 2. Guidelines should be updated each time there is a modification of knowledge: it is extremely difficult to do. 3. A great number of guidelines exist, issued by scientific community, health authorities or the payers. Sometime you can find a proposition in a guideline and the reverse in another guideline. It could be confusing. 4. Guidelines should be evaluated rigorously to know if they fulfil their goals. 5. Some of those guidelines simply cannot help doctors. They are too complex or do not take into account practical situations.We have made an inventory of those various guidelines and their weaknesses and we propose some solutions to increase their utility. We propose an analysis of the situation and some solutions to improve the quality and the relevance of the guidelines: to create groups of coordination

  13. Promising Practices in Mathematics & Science Education: A Collection of Promising Educational Programs & Practices from the Laboratory Network Program.

    ERIC Educational Resources Information Center

    Office of Educational Research and Improvement (ED), Washington, DC.

    This volume of 66 promising practices in mathematics and science education developed by the 10 regional educational laboratories funded by the U.S. Department of Education's Office of Educational Research and Improvement. The laboratories' collection of programs emerged from a broad-based search, nomination, and review process reaching educators…

  14. 78 FR 17142 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-20

    ... correcting the January 16, 2013 (78 FR 3646), proposed rule entitled ``Current Good Manufacturing Practice... Appendix in which all references are numbered incorrectly. This document corrects those errors. In FR Doc... proposed rule to establish CGMP requirements for dietary ingredients and dietary supplements (68 FR...

  15. Applying the Seven Principles of Good Practice: Technology as a Lever--In an Online Research Course

    ERIC Educational Resources Information Center

    Johnson, Sherryl

    2014-01-01

    This article provides an overview of the seven principles of good practice with emphasis on the implementation of technology in an online healthcare research class in a southwest Georgia (United States) university. The seven principles are outlined using various elements of the online course. Historical and philosophical reasoning are applied to…

  16. 78 FR 64425 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-29

    ... Meeting on Proposed Rule AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meeting... proposed rule to establish requirements for current good manufacturing practice and hazard analysis and risk-based preventive controls for animal food. This proposed rule is one of several proposed...

  17. Good Practice in Promoting Gender Equality in Higher Education in Central and Eastern Europe. Studies on Higher Education.

    ERIC Educational Resources Information Center

    Grunberg, Laura

    This volume publishes the results of the United Nations Educational, Scientific, and Cultural Organization (UNESCO) European Centre for Higher Education (CEPES) project, Good Practice in Promoting Gender Inequality in Higher Education in Central and Eastern Europe and the former Soviet Countries. These case studies offer hope for a future in which…

  18. Ideas and Realities: Investigating Good Practice in the Management of Transnational English Language Programmes for the Higher Education Sector

    ERIC Educational Resources Information Center

    Dunworth, Katie

    2008-01-01

    This paper describes the findings of an Australian Government-funded research project that sought to investigate the management of transnational English-language teaching programmes in the higher education sector with a view to identifying those activities that both facilitate and inhibit good practice as defined in the paper. Using data obtained…

  19. DETERMINATION OF GOOD-ENGINEERING-PRACTICE STACK HEIGHT: A FLUID MODE DEMONSTRATION STUDY FOR A POWER PLANT

    EPA Science Inventory

    A study using fluid modeling to determine good-engineering-practice (GEP) stack height for a power plant installation is discussed. Measurements are presented to describe the simulated boundary layer structure, plume dispersion characteristics in the absence of the model plant bu...

  20. School Leadership and Equity: The Case of Antwerp--A Report on Good Practices in Three Primary Schools

    ERIC Educational Resources Information Center

    Mahieu, Paul; Clycq, Noel

    2007-01-01

    This article focuses on the good practices in three primary schools in the city of Antwerp, Belgium. First we start with a walk through the Flemish educational system and sum up the legislation concerned. After that we give a detailed overview of the pupil population of the three schools selected. Finally, the data from the interviews are analysed…

  1. Good practice in health care for migrants: views and experiences of care professionals in 16 European countries

    PubMed Central

    2011-01-01

    Background Health services across Europe provide health care for migrant patients every day. However, little systematic research has explored the views and experiences of health care professionals in different European countries. The aim of this study was to assess the difficulties professionals experience in their service when providing such care and what they consider constitutes good practice to overcome these problems or limit their negative impact on the quality of care. Methods Structured interviews with open questions and case vignettes were conducted with health care professionals working in areas with high proportion of migrant populations in 16 countries. In each country, professionals in nine primary care practices, three accident and emergency hospital departments, and three community mental health services (total sample = 240) were interviewed about their views and experiences in providing care for migrant patients, i.e. from first generation immigrant populations. Answers were analysed using thematic content analysis. Results Eight types of problems and seven components of good practice were identified representing all statements in the interviews. The eight problems were: language barriers, difficulties in arranging care for migrants without health care coverage, social deprivation and traumatic experiences, lack of familiarity with the health care system, cultural differences, different understandings of illness and treatment, negative attitudes among staff and patients, and lack of access to medical history. The components of good practice to overcome these problems or limit their impact were: organisational flexibility with sufficient time and resources, good interpreting services, working with families and social services, cultural awareness of staff, educational programmes and information material for migrants, positive and stable relationships with staff, and clear guidelines on the care entitlements of different migrant groups. Problems and

  2. What Is "Good" Teaching? Teacher Beliefs and Practices about Their Teaching

    ERIC Educational Resources Information Center

    Devine, Dympna; Fahie, Declan; McGillicuddy, Deirdre

    2013-01-01

    There has been increasing attention on teacher "quality" and effectiveness internationally. There is, however, little research documenting experienced teachers' classroom practices and their beliefs on why they teach the way they do. Drawing on a mixed methodological study of practices and beliefs across 12 primary and secondary schools, this…

  3. Regulative Practices in a "Progressivist" Classroom: "Good Habits" as a "Disciplinary Technology".

    ERIC Educational Resources Information Center

    Chouliaraki, Lille

    1996-01-01

    Explores a set of pedagogic practices in a 'progressivist' classroom as practices of covert institutional regulation. The article attempts to show how the instructional potential of the pedagogic act is subordinated to the regulative rules of the institutional context of the classroom, so that following classroom rules becomes the main focus of…

  4. PRACTICAL FAST GAS CHROMATOGRAPHY FOR CONTRACT LABORATORY PROGRAM PESTICIDE ANALYSES

    EPA Science Inventory

    An approach to shortening the analysis time for practical fast gas chromatography (GC) by using Method Translator software, which can be downloaded free from the Internet, is presented. This sofware simplifies the process of optimizing temperature programming while changing colu...

  5. The Good Housewife Exercise: Linking Citation to Practices, Evidence, and Claims.

    ERIC Educational Resources Information Center

    Hansberger, Richard

    1999-01-01

    Presents a one-class-period writing exercise (including handout) which uses a short excerpt from a 1948 book called "Making Housekeeping Easy" to teach the linking of claims to evidence as well as academic citation practices. (SR)

  6. A Practical Polymerase Chain Reaction Laboratory for Introductory Biology Classes.

    ERIC Educational Resources Information Center

    Bowlus, R. David; Grether, Susan C.

    1996-01-01

    Presents a polymerase chain reaction (PCR) laboratory exercise that can be performed by introductory biology students in 1 45- to 55-minute class period. Includes a general description of the polymerase chain reaction, materials needed, procedure, and details of interest to teachers. (JRH)

  7. Students Integrate Knowledge Acquisition and Practical Work in the Laboratory

    ERIC Educational Resources Information Center

    Agüera, E. I.; Sánchez-Hermosín, P.; Díz-Pérez, J.; Tovar, P.; Camacho, R.; Escribano, B. M.

    2015-01-01

    The aim of the present work was to transfer a wider concept of teamwork and self-learning to the laboratory, encouraging students' capabilities when seeking, acquiring, and processing knowledge. This educational innovation was carried out with a total of 38 students (fourth year of degree in Biology) in the area of physiology (Advances in…

  8. Characterizing Instructional Practices in the Laboratory: The Laboratory Observation Protocol for Undergraduate STEM

    ERIC Educational Resources Information Center

    Velasco, Jonathan B.; Knedeisen, Adam; Xue, Dihua; Vickrey, Trisha L.; Abebe, Marytza; Stains, Marilyne

    2016-01-01

    Chemistry laboratories play an essential role in the education of undergraduate Science, Technology, Engineering, and Mathematics (STEM) and non-STEM students. The extent of student learning in any educational environment depends largely on the effectiveness of the instructors. In chemistry laboratories at large universities, the instructors of…

  9. Raising the Achievement of Portuguese Pupils in British Schools: A Case Study of Good Practice

    ERIC Educational Resources Information Center

    Demie, Feyisa; Lewis, Kirstin

    2010-01-01

    The aim of the research was to study the experiences of Portuguese heritage pupils in British schools. The main findings from empirical data suggest Portuguese children are underachieving at the end of primary education but the case study confirms that in good schools Portuguese pupils do well and have made huge improvements over the periods. The…

  10. Good Practices for Whom? A Vital Question for Understanding the First Year of College

    ERIC Educational Resources Information Center

    Goodman, Kathleen M.

    2014-01-01

    This chapter demonstrates that the effects of good teaching and academic challenge on leadership and psychological well-being during the first year of college differ for African-American and White students, which suggests that institutional researchers should disaggregate data by race or other relevant student characteristics when trying to…

  11. Contextualizing Practices across Epistemic Levels in the Chemistry Laboratory

    ERIC Educational Resources Information Center

    Jimenez-Aleixandre, Maria-Pilar; Reigosa, Carlos

    2006-01-01

    The process of construction of meanings for the concepts of concentration and neutralization is explored in terms of "contextualizing practices" (Lemke, 1990, "Talking Science. Language, Learning and Values," Norwood, NJ: Ablex) creation of meanings through connections established among actions and their context. This notion is expanded to include…

  12. Identification of good practices for teachers and students training activity in the ENVRIPLUS project

    NASA Astrophysics Data System (ADS)

    D'Addezio, Giuliana; Marsili, Antonella; Beranzoli, Laura

    2016-04-01

    We elaborated basic guiding principles that will be used to improve the content of the ENVRIPLUS e-Training Platform for multimedia education of Secondary School level teachers and students. The purpose is to favour teacher training and consequently students training on selected scientific themes faced within the ENVRIPLUS Research Infrastructures. "Best practices" could positively impacts on students by providing motivation on promoting scientific research and to increase the awareness of the Earth System complexity and Environmental challenges for its preservation and sustainability. Best practice teaching strategies represent an inherent part of a curriculum that exemplifies the connection and relevance identified in education research. The actions are designed to develop thinking and problem-solving skill through integration and active learning. Relationships are built though opportunities for communication and teamwork. Best practices motivate, engage and prompt student to learn and achieve. A starting list of principles is discussed in respect of the following main Best Practices pillars: • Identify the conceptual framework of the subject of the dissemination • Increase personal awareness of the individual potential • Easy personal elaboration and the connection of the subject with the school curriculum.

  13. Good Images, Effective Messages? Working with Students and Educators on Academic Practice Understanding

    ERIC Educational Resources Information Center

    Gannon-Leary, Pat; Trayhurn, Deborah; Home, Margaret

    2009-01-01

    Work at Northumbria University has focussed on activity that extends opportunities for students to engage directly with the skills development necessary for sound academic practice. This has included highly visual campaigns on the "Plagiarism trap", providing access to Turnitin plagiarism detection software, guides and sessions to highlight use of…

  14. Good Teachers and Deviant Learners? The Meeting of Practices in University Level International Education

    ERIC Educational Resources Information Center

    Tange, Hanne; Jensen, Iben

    2012-01-01

    The article focuses on the impact of internationalization on university lecturers' practice. Based on interviews with 36 employees from Danish universities, we discuss what internationalization means for the classroom relationship between university teachers and international students. The article is inspired by an intercultural communication…

  15. Good Teaching? An Examination of Culturally Relevant Pedagogy as an Equity Practice

    ERIC Educational Resources Information Center

    Schmeichel, Mardi

    2012-01-01

    The adoption of educational policy measures to close the achievement gap, as well as the significant amount of scholarship dedicated to the subject, are just some of the indicators that reflect the tremendous concern in education about the academic performance of students of colour. Within research aimed at promoting equitable practices in…

  16. Beyond "It Was Good": Students' Post-Study Abroad Practices for Negotiating Meaning

    ERIC Educational Resources Information Center

    Kortegast, Carrie A.; Boisfontaine, M. Terral

    2015-01-01

    Student participation in short-term study abroad programs has increased at a rapid pace; however, little is known about students' post--study abroad practices regarding negotiating meaning of their experiences. The purpose of this study is to explore students' post-study abroad participation and reification of their experiences using the…

  17. The Good, the Bad, and the Ugly of Evidence-Based Practice

    ERIC Educational Resources Information Center

    Bouffard, Marcel; Reid, Greg

    2012-01-01

    The evidence-based practice (EBP) movement has been extremely influential over the last 20 years. Fields like medicine, physiotherapy, occupational therapy, nursing, psychology, and education have adopted the idea that policy makers and practitioners should use interventions that have demonstrated efficiency and effectiveness. This apparently…

  18. Good CoP: What Makes a Community of Practice Successful?

    ERIC Educational Resources Information Center

    Baker, Anthony; Beames, Stephanie

    2016-01-01

    We have established a community of practice focussed on student learning in first-year science. It is recognised that transition, whether from school to university or other possible transitions, is an issue that is a concern for the entire sector, and this is acknowledged both at Faculty and University level. One of the factors to which we…

  19. Effective Superintendent-School Board Practices: Strategies for Developing and Maintaining Good Relationships with Your Board

    ERIC Educational Resources Information Center

    Townsend, Rene S.; Johnston, Gloria L.; Gross, Gwen E.; Lynch, Peggy; Garcy, Lorraine M.; Roberts, Benita B.; Novotney, Patricia B.

    2006-01-01

    Foster a strong superintendent-school board relationship centered on quality teaching and learning! This book helps current and future superintendents and school board members develop an effective governance team that prioritizes quality teaching and learning. Designed for practicing and aspiring superintendents and school board members, this…

  20. Theory in Practice: Why "Good Medicine" and "Scientific Medicine" Are Not Necessarily the Same Thing

    ERIC Educational Resources Information Center

    De Camargo, Kenneth, Jr.; Coeli, Claudia Medina

    2006-01-01

    The term "scientific medicine", ubiquitous in medical literature although poorly defined, can be traced to a number of assumptions, three of which are examined in this paper: that medicine is a form of knowledge-driven practice, where the established body of proven medical knowledge determines what doctors do; if what doctors do is either…

  1. Becoming a Good Doctor: Perceived Need for Ethics Training Focused on Practical and Professional Development Topics

    ERIC Educational Resources Information Center

    Roberts, Laura W.; Warner, Teddy D.; Green Hammond, Katherine A.; Geppert, Cynthia M. A.; Heinrich, Thomas

    2005-01-01

    Objective: Ethics training has become a core component of medical student and resident education. Curricula have been developed without the benefit of data regarding the views of physicians-in-training on the need for ethics instruction that focuses on practical issues and professional development topics. Methods: A written survey was sent to all…

  2. Web-based Learning Environments Guided by Principles of Good Teaching Practice.

    ERIC Educational Resources Information Center

    Chizmar, John F.; Walbert, Mark S.

    1999-01-01

    Describes the preparation and execution of a statistics course, an undergraduate econometrics course, and a microeconomic theory course that all utilize Internet technology. Reviews seven principles of teaching practice in order to demonstrate how to enhance the quality of student learning using Web technologies. Includes reactions by Steve Hurd…

  3. Laboratories for the 21st Century Best Practices: Energy Recovery in Laboratory Facilities

    SciTech Connect

    2012-06-01

    Laboratories typically require 100% outside air for ventilation at higher rates than other commercial buildings. Minimum ventilation is typically provided at air change per hour (ACH) rates in accordance with codes and adopted design standards including Occupational Safety and Health Administration (OSHA) Standard 1910.1450 (4 to 12 ACH – non-mandatory) or the 2011 American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) Applications Handbook, Chapter 16 – Laboratories (6 to 12 ACH). While OSHA states this minimum ventilation rate “should not be relied on for protection from toxic substances released into the laboratory” it specifically indicates that it is intended to “provide a source of air for breathing and for input to local ventilation devices (e.g., chemical fume hoods or exhausted bio-safety cabinets), to ensure that laboratory air is continually replaced preventing the increase of air concentrations of toxic substances during the working day, direct air flow into the laboratory from non-laboratory areas and out to the exterior of the building.” The heating and cooling energy needed to condition and move this outside air can be 5 to 10 times greater than the amount of energy used in most office buildings. In addition, when the required ventilation rate exceeds the airflow needed to meet the cooling load in low-load laboratories, additional heating energy may be expended to reheat dehumidified supply air from the supply air condition to prevent over cooling. In addition to these low-load laboratories, reheat may also be required in adjacent spaces such as corridors that pro-vide makeup air to replace air being pulled into negative-pressure laboratories.

  4. A Laboratory Practical on the House Building Behaviour of Caddis Larvae

    ERIC Educational Resources Information Center

    Hansell, M. H.

    1973-01-01

    Describes a laboratory practical on animal behavior suitable for senior secondary school or university biology classes. Several separate exercises relating to the house building behavior of caddis fly larvae are detailed, together with the time required for preparation. (JR)

  5. [Providing studies quality for pesticides risk evaluation in their use according to proper laboratory practice rules].

    PubMed

    Rakitskiy, V N; Bereznyak, I V

    2016-01-01

    The article covers experience of proper laboratory practice in hygienic studies examining air and workers' skin for assessment of exposure levels of pesticides in natural conditions of agricultural production. PMID:27265940

  6. Current good manufacturing practices, quality control procedures, quality factors, notification requirements, and records and reports, for infant formula. Final rule.

    PubMed

    2014-06-10

    The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled "Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula'' (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR. PMID:24922980

  7. Emissions of dioxins and furans from garbage-burning incinerators can be minimized by good combustion practices

    SciTech Connect

    Not Available

    1987-10-01

    The American Society of Mechanical Engineers (ASME) have stated that emissions of dioxin and furan from garbage-burning incinerators can be minimized by good combustion practices. They have found that maintaining the heat of combustion above 815 degrees centigrade and reducing the carbon monoxide level to below 100 ppm will reduce the emissions of furan and dioxin. The combustion research that lead to these conclusions was sponsored by ASME and the New York energy authority

  8. A framework for good practice in interagency interventions with cases of self-neglect.

    PubMed

    Lauder, W; Anderson, I; Barclay, A

    2005-04-01

    Self-neglect is probably more common than has generally been thought and gives rise to a number of difficult conceptual, identification and intervention problems for health and social care workers. These patient management issues are compounded by the lack of any evidence-base for practice which nurses can draw on when faced with managing people who self-neglect. Nurses working with self-neglecters operate in an interdisciplinary context which includes professional groups, such as environmental health officers, who do not normally figure within health and social care teams. In the absence of such an evidence-base, a pragmatic solution in the form of a framework for interagency practice has been proposed. The background underpinning this framework, including a research study of housing in self-neglect and interagency responses, is briefly outlined in this paper. PMID:15788037

  9. Gaia Launch Imminent: A Review of Practices (Good and Bad) in Building the Gaia Ground Segment

    NASA Astrophysics Data System (ADS)

    O'Mullane, W.

    2014-05-01

    As we approach launch the Gaia ground segment is ready to process a steady stream of complex data coming from Gaia at L2. This talk will focus on the software engineering aspects of the ground segment. Of course in a short paper it is difficult to cover everything but an attempt will be made to highlight some good things, like the Dictionary Tool and some things to be careful with like computer aided software engineering tools. The usefulness of some standards like ECSS will be touched upon. Testing is also certainly part of this story as are Challenges or Rehearsals so they will not go without mention.

  10. Moving Research to Practice in America's Schools. Annual Report of the Regional Educational Laboratories, 1997.

    ERIC Educational Resources Information Center

    Office of Educational Research and Improvement (ED), Washington, DC.

    The network of 10 Regional Educational Laboratories works to ensure that those involved in educational improvement at the local, state, and regional levels have access to the best available information from research and practice. This report highlights major 1997 accomplishments of the Regional Educational Laboratory Program supported by contracts…

  11. A Survey of the Practices, Procedures, and Techniques in Undergraduate Organic Chemistry Teaching Laboratories

    ERIC Educational Resources Information Center

    Martin, Christopher B.; Schmidt, Monica; Soniat, Michael

    2011-01-01

    A survey was conducted of four-year institutions that teach undergraduate organic chemistry laboratories in the United States. The data include results from over 130 schools, describes the current practices at these institutions, and discusses the statistical results such as the scale of the laboratories performed, the chemical techniques applied,…

  12. Laboratory Practices of Beginning Secondary Science Teachers: A Five-Year Study

    ERIC Educational Resources Information Center

    Wong, Sissy S.; Firestone, Jonah B.; Luft, Julie A.; Weeks, Charles B.

    2013-01-01

    During the beginning years of teaching, science teachers develop the knowledge and skills needed to design and implement science laboratories. In this regard, this quantitative study focused on the reported laboratory practices of 61 beginning secondary science teachers who participated in four different induction programs. The results…

  13. The Laboratory Culture of Eucyclops Agilis (Koch) and Suggestions for Its Use in Practical Work.

    ERIC Educational Resources Information Center

    Comber, D. H.

    1979-01-01

    Describes a technique for the laboratory culture of Eucyclops agilis using Euglena. Details of the life cycle are given, and suggestions for its use in laboratory practicals, and in investigations with sixth-form (16 to 18 year-olds) and college students in the United Kingdom. (Author/HM)

  14. Blending Learning: A Novel Assessment Strategy Enhancing Student Learning from Practical Work in the Laboratory

    ERIC Educational Resources Information Center

    Walsh, Cathy; Parry, Damian; Larsen, Carl

    2010-01-01

    In this communication we report on a "blended" form of assessment combining the positive aspects of a laboratory investigation, including practical skill acquisition, data reporting and social interaction, with the application and authenticity of a case study encouraging students to deepen their learning from laboratory activities. (Contains 2…

  15. Prepare, Do, Review: A Skills-Based Approach for Laboratory Practical Classes in Biochemistry and Molecular Biology

    ERIC Educational Resources Information Center

    Arthur, Peter; Ludwig, Martha; Castelli, Joane; Kirkwood, Paul; Attwood, Paul

    2016-01-01

    A new laboratory practical system is described which is comprised of a number of laboratory practical modules, each based around a particular technique or set of techniques, related to the theory part of the course but not designed to be dependent on it. Each module comprises an online recorded pre-lab lecture, the laboratory practical itself and…

  16. Practical use of a word processor in a histopathology laboratory.

    PubMed Central

    Briggs, J C; Ibrahim, N B; Mackintosh, I; Norris, D

    1982-01-01

    Some of the facilities available with a commercially purchased word processing program, linked to a DEC PDP 11/23 computer are described, together with an account of the practical histopathological use. The system is based on a share of the computer with a Clinical Chemistry Department. Development was time-consuming and required the constant availability of the Department of Physics. However, once working, considerable saving in secretarial time has resulted and a number of projects have been started which would not have been contemplated without the use of the word processor and its linked computer. Images PMID:7068906

  17. International survey for good practices in forecasting uncertainty assessment and communication

    NASA Astrophysics Data System (ADS)

    Berthet, Lionel; Piotte, Olivier

    2014-05-01

    Achieving technically sound flood forecasts is a crucial objective for forecasters but remains of poor use if the users do not understand properly their significance and do not use it properly in decision making. One usual way to precise the forecasts limitations is to communicate some information about their uncertainty. Uncertainty assessment and communication to stakeholders are thus important issues for operational flood forecasting services (FFS) but remain open fields for research. French FFS wants to publish graphical streamflow and level forecasts along with uncertainty assessment in near future on its website (available to the greater public). In order to choose the technical options best adapted to its operational context, it carried out a survey among more than 15 fellow institutions. Most of these are providing forecasts and warnings to civil protection officers while some were mostly working for hydroelectricity suppliers. A questionnaire has been prepared in order to standardize the analysis of the practices of the surveyed institutions. The survey was conducted by gathering information from technical reports or from the scientific literature, as well as 'interviews' driven by phone, email discussions or meetings. The questionnaire helped in the exploration of practices in uncertainty assessment, evaluation and communication. Attention was paid to the particular context within which every insitution works, in the analysis drawn from raw results. Results show that most services interviewed assess their forecasts uncertainty. However, practices can differ significantly from a country to another. Popular techniques are ensemble approaches. They allow to take into account several uncertainty sources. Statistical past forecasts analysis (such as the quantile regressions) are also commonly used. Contrary to what was expected, only few services emphasize the role of the forecaster (subjective assessment). Similar contrasts can be observed in uncertainty

  18. Low-cost risk reduction strategy for small workplaces: how can we spread good practices?

    PubMed

    Kogi, K

    2006-01-01

    Recent advances in health risk reduction approaches are examined based on inter-country networking experiences. A noteworthy progress is the wider application of low-cost improvements to risk reduction particularly in small enterprises and agriculture in both industrially developing and developed countries. This is helped by the readiness of managers and workers to implement these improvements despite many constraints. Typical improvements include mobile racks, simple workstation changes, screening hazards, better welfare facilities and teamwork arrangements. In view of the complex circumstances of work-related health risks, it is important to know whether a low-cost strategy can advance risk reduction practices effectively and what support measures are necessary. It is confirmed that the strategy can overcome related constraints through its advantages. Main advantages lie in (a) the facilitation of improved practices in multiple technical areas, (b) the strengthening of realistic stepwise risk reduction, and (c) the enhanced multiplier effects through training of local trainers. Action-oriented risk assessment tools, such as action checklists and low-cost improvement guides, can encourage risk-reducing measures adjusted to each local situation. It is suggested to spread the low-cost risk reduction strategy for improving small workplaces in diversified settings with the support of these locally tailored tools. PMID:17017363

  19. Reflective Practice: A Place in Enhancing Learning in the Undergraduate Bioscience Teaching Laboratory?

    ERIC Educational Resources Information Center

    Parry, Damian; Walsh, Cathy; Larsen, Carl; Hogan, Joanne

    2012-01-01

    Bioscience employers demand graduates with better practical competence. It is our supposition that, although undesirable, student learning is assessment driven and this is leading students to simply go through the motions in the practical setting (whether field work or laboratory based). In this intervention a Critical Incident Report was…

  20. Designing and Conducting a Purification Scheme as an Organic Chemistry Laboratory Practical

    ERIC Educational Resources Information Center

    Graham, Kate J.; Johnson, Brian J.; Jones, T. Nicholas; McIntee, Edward J.; Schaller, Chris P.

    2008-01-01

    An open-ended laboratory practical has been developed that challenges students to evaluate when different purification techniques are appropriate. In contrast to most lab practicals, the overall grade includes an evaluation of spectral analysis as well as writing skills. However, a significant portion of the grade lies in successful execution of a…

  1. Conditions for Building a Community of Practice in an Advanced Physics Laboratory

    ERIC Educational Resources Information Center

    Irving, Paul W.; Sayre, Eleanor C.

    2014-01-01

    We use the theory of communities of practice and the concept of accountable disciplinary knowledge to describe how a learning community develops in the context of an upper-division physics laboratory course. The change in accountable disciplinary knowledge motivates students' enculturation into a community of practice. The enculturation…

  2. Biosafety Practices and Emergency Response at the Idaho National Laboratory and Los Alamos National Laboratory

    SciTech Connect

    Frank F. Roberto; Dina M. Matz

    2008-03-01

    Strict federal regulations govern the possession, use, and transfer of pathogens and toxins with potential to cause harm to the public, either through accidental or deliberate means. Laboratories registered through either the Centers for Disease Control and Prevention (CDC), the U.S. Dept. of Agriculture (USDA), or both, must prepare biosafety, security, and incident response plans, conduct drills or exercises on an annual basis, and update plans accordingly. At the Idaho National Laboratory (INL), biosafety, laboratory, and emergency management staff have been working together for 2 years to satisfy federal and DOE/NNSA requirements. This has been done through the establishment of plans, training, tabletop and walk-through exercises and drills, and coordination with local and regional emergency response personnel. Responding to the release of infectious agents or toxins is challenging, but through familiarization with the nature of the hazardous biological substances or organisms, and integration with laboratory-wide emergency response procedures, credible scenarios are being used to evaluate our ability to protect workers, the public, and the environment from agents we must work with to provide for national biodefense.

  3. Percutaneous coronary intervention in the UK: recommendations for good practice 2015

    PubMed Central

    Banning, Adrian P; Baumbach, Andreas; Blackman, Dan; Curzen, Nick; Devadathan, Sen; Fraser, Douglas; Ludman, Peter; Norell, Micheal; Muir, Dougie; Nolan, James; Redwood, Simon

    2015-01-01

    Over the last 35 years, there has been dramatic progress in the technology and applicability of percutaneous techniques to treat obstructive coronary heart disease. Percutaneous coronary intervention (PCI) has a considerable evidence base and it is firmly established as the most common procedure used in the invasive treatment of patients with coronary heart disease in the UK. This set of guidelines aims to address specifically issues relating to PCI and not the growing subspecialty of structural heart disease intervention. It is not intended to provide a review of the entire evidence base for coronary intervention. The evidence base relating to PCI is extensively reviewed in international guidelines and the British Cardiovascular Intervention society endorses these guidelines and their updates. The guidelines presented here focus on issues pertinent to practice within the UK and set out a recommended template to ensure optimal delivery of patient care. PMID:26041756

  4. Good practices for prone positioning at the bedside: Construction of a care protocol.

    PubMed

    Oliveira, Vanessa Martins de; Weschenfelder, Michele Elisa; Deponti, Gracieli; Condessa, Robledo; Loss, Sergio Henrique; Bairros, Patrícia Maurello; Hochegger, Thais; Daroncho, Rogério; Rubin, Bibiana; Chisté, Marcele; Batista, Danusa Cassiana Rigo; Bassegio, Deise Maria; Nauer, Wagner da Silva; Piekala, Daniele Martins; Minossi, Silvia Daniela; Santos, Vanessa Fumaco da Rosa Dos; Victorino, Josue; Vieira, Silvia Regina Rios

    2016-01-01

    Last year, interest in prone positioning to treat acute respiratory distress syndrome (ARDS) resurfaced with the demonstration of a reduction in mortality by a large randomized clinical trial. Reports in the literature suggest that the incidence of adverse events is significantly reduced with a team trained and experienced in the process. The objective of this review is to revisit the current evidence in the literature, discuss and propose the construction of a protocol of care for these patients. A search was performed on the main electronic databases: Medline, Lilacs and Cochrane Library. Prone positioning is increasingly used in daily practice, with properly trained staff and a well established care protocol are essencial. PMID:27310555

  5. Access to and value of information to support good practice for staff in Kenyan hospitals

    PubMed Central

    Muinga, Naomi; Sen, Barbara; Ayieko, Philip; Todd, Jim; English, Mike

    2015-01-01

    Background Studies have sought to define information needs of health workers within very specific settings or projects. Lacking in the literature is how hospitals in low-income settings are able to meet the information needs of their staff and the use of information communication technologies (ICT) in day-to-day information searching. Objective The study aimed to explore where professionals in Kenyan hospitals turn to for work-related information in their day-to-day work. Additionally, it examined what existing solutions are provided by hospitals with regard to provision of best practice care. Lastly, the study explored the use of ICT in information searching. Design Data for this study were collected in July 2012. Self-administered questionnaires (SAQs) were distributed across 22 study hospitals with an aim to get a response from 34 health workers per hospital. Results SAQs were collected from 657 health workers. The most popular sources of information to guide work were fellow health workers and printed guidelines while the least popular were scientific journals. Of value to health workers were: national treatment policies, new research findings, regular reports from surveillance data, information on costs of services and information on their performance of routine clinical tasks; however, hospitals only partially met these needs. Barriers to accessing information sources included: ‘not available/difficult to get’ and ‘difficult to understand’. ICT use for information seeking was reported and with demographic specific differences noted from the multivariate logistic regression model; nurses compared to medical doctors and older workers were less likely to use ICT for health information searching. Barriers to accessing Internet were identified as: high costs and the lack of the service at home or at work. Conclusions Hospitals need to provide appropriate information by improving information dissemination efforts and providing an enabling environment that

  6. Making sense of how physician preceptors interact with medical students: discourses of dialogue, good medical practice, and relationship trajectories.

    PubMed

    van der Zwet, J; Dornan, T; Teunissen, P W; de Jonge, L P J W M; Scherpbier, A J J A

    2014-03-01

    Work based learning and teaching in health care settings are complex and dynamic. Sociocultural theory addresses this complexity by focusing on interaction between learners, teachers, and their environment as learners develop their professional identity. Although social interaction between doctors and students plays a crucial role in this developmental process, socio-cultural research from the perspective of doctors is scarce. We performed discourse analysis on seven general practitioners' audio diaries during a 10-week general practice clerkship to study how they gave shape to their interaction with their students. Examination of 61 diary-entries revealed trajectories of developing relationships. These trajectories were initiated by the way respondents established a point of departure, based on their first impression of the students. It continued through the development of dialogue with their student and through conceptualizations of good medical practice. Such conceptualizations about what was normal in medical and educational practice enabled respondents to recognize qualities in the student and to indirectly determine students' desired learning trajectory. Towards the end, discursive turns in respondents' narratives signaled development within the relationship. This became evident in division of roles and positions in the context of daily practice. Although respondents held power in the relationships, we found that their actions depended strongly on what the students afforded them socially. Our findings address a gap in literature and could further inform theory and practice, for example by finding out how to foster constructive dialogue between doctors and students, or by exploring different discourses among learners and teachers in other contexts. PMID:23771397

  7. Good research practices: a commonsense approach to ensuring quality in research facilities.

    PubMed

    Herman, D R; Usher, R W

    1994-12-01

    This guideline can be a useful tool for assisting and assessing "non-GLP" laboratories in academic and contract settings. This guideline has proven useful in assessing academic and/or contract labs where a final product is needed which would meet FDA expectations for preclinical or clinical research. Because of differing research settings and study types, we apply the standards in a flexible manner. For example, in some settings, the study plan is simply documented in a research notebook as the study unfolds, whereas in other settings a written protocol (which is signed by the principal investigator) is in place prior to study initiation. Additionally, all criteria may not be applicable to every research facility. The focus of this guideline is to ensure that sufficient documentation exists which will allow for study reconstruction and to provide adequate evidence that the raw data generated by the facility are accurate. This guideline is a useful tool for Quality Assurance personnel and can also be used by research personnel in the development of appropriate quality systems for their research environment. PMID:7613744

  8. Good practice recommendations for paediatric outpatient parenteral antibiotic therapy (p-OPAT) in the UK: a consensus statement.

    PubMed

    Patel, Sanjay; Abrahamson, Ed; Goldring, Stephen; Green, Helen; Wickens, Hayley; Laundy, Matt

    2015-02-01

    There is compelling evidence to support the rationale for managing children on intravenous antimicrobial therapy at home whenever possible, including parent and patient satisfaction, psychological well-being, return to school/employment, reductions in healthcare-associated infection and cost savings. As a joint collaboration between the BSAC and the British Paediatric Allergy, Immunity and Infection Group, we have developed good practice recommendations to highlight good clinical practice and governance within paediatric outpatient parenteral antibiotic therapy (p-OPAT) services across the UK. These guidelines provide a practical approach for safely delivering a p-OPAT service in both secondary care and tertiary care settings, in terms of the roles and responsibilities of members of the p-OPAT team, the structure required to deliver the service, identifying patients and pathologies that are suitable for p-OPAT, ensuring appropriate vascular access, antimicrobial choice and delivery and the clinical governance aspects of delivering a p-OPAT service. The process of writing a business case to support the introduction of a p-OPAT service is also addressed. PMID:25331058

  9. Low-event-rate meta-analyses of clinical trials: implementing good practices.

    PubMed

    Shuster, Jonathan J; Walker, Michael A

    2016-06-30

    Meta-analysis of clinical trials is a methodology to summarize information from a collection of trials about an intervention, in order to make informed inferences about that intervention. Random effects allow the target population outcomes to vary among trials. Since meta-analysis is often an important element in helping shape public health policy, society depends on biostatisticians to help ensure that the methodology is sound. Yet when meta-analysis involves randomized binomial trials with low event rates, the overwhelming majority of publications use methods currently not intended for such data. This statistical practice issue must be addressed. Proper methods exist, but they are rarely applied. This tutorial is devoted to estimating a well-defined overall relative risk, via a patient-weighted random-effects method. We show what goes wrong with methods based on 'inverse-variance' weights, which are almost universally used. To illustrate similarities and differences, we contrast our methods, inverse-variance methods, and the published results (usually inverse-variance) for 18 meta-analyses from 13 Journal of the American Medical Association articles. We also consider the 2007 case of rosiglitazone (Avandia), where important public health issues were at stake, involving patient cardiovascular risk. The most widely used method would have reached a different conclusion. © 2016 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. PMID:26728099

  10. Practical Application of Electrochemical Nitrate Sensor under Laboratory and Forest Nursery Conditions.

    PubMed

    Caron, William-Olivier; Lamhamedi, Mohammed S; Viens, Jeff; Messaddeq, Younès

    2016-01-01

    The reduction of nitrate leaching to ensure greater protection of groundwater quality has become a global issue. The development of new technologies for more accurate dosing of nitrates helps optimize fertilization programs. This paper presents the practical application of a newly developed electrochemical sensor designed for in situ quantification of nitrate. To our knowledge, this paper is the first to report the use of electrochemical impedance to determine nitrate concentrations in growing media under forest nursery conditions. Using impedance measurements, the sensor has been tested in laboratory and compared to colorimetric measurements of the nitrate. The developed sensor has been used in water-saturated growing medium and showed good correlation to certified methods, even in samples obtained over a multi-ion fertilisation season. A linear and significant relationship was observed between the resistance and the concentration of nitrates (R² = 0.972), for a range of concentrations of nitrates. We also observed stability of the sensor after exposure of one month to the real environmental conditions of the forest nursery. PMID:27483266

  11. The Utilization of the Seven Principles for Good Practices of Full-Time and Adjunct Faculty in Teaching Health & Science in Community Colleges

    ERIC Educational Resources Information Center

    Musaitif, Linda M.

    2013-01-01

    Purpose: The purpose of this study was to determine the degree to which undergraduate full-time and adjunct faculty members in the health and science programs at community colleges in Southern California utilize the seven principles of good practice as measured by the Faculty Inventory of the Seven Principles for Good Practice in Undergraduate…

  12. Evidence-based practice in Steeltown: a good start on needed cultural change.

    PubMed

    Lomas, Johnathan

    2003-01-01

    . Browman and colleagues 'practical realization of Sabatier' advocacy coalition framework and Browns social view of information is refreshing on a number of levels. PMID:12811084

  13. A Modular Pharmacy Practice Laboratory Course Integrating Role-Playing Scenarios with Community and Hospital Practice.

    ERIC Educational Resources Information Center

    Triplett, John W.; And Others

    1992-01-01

    This paper describes the development and evolution of a modular pharmacy practice course that uses practitioners as role-model instructors in prepared and impromptu scenarios. The course reviews the top 200 drug products while introducing students to both community and institutional practice settings. Appendices include a summary of the…

  14. Production of good manufacturing practice-grade human umbilical cord blood-derived mesenchymal stem cells for therapeutic use.

    PubMed

    Van Pham, Phuc; Phan, Ngoc Kim

    2015-01-01

    Human umbilical cord blood-derived mesenchymal stem cells (UCB-MSCs) are multipotent stem cells that can be differentiated into several specific cell types such as adipocytes, osteoblasts, and chondroblasts. They also were demonstrated to trans-differentiate into other cell lineages such as muscle cells and neurons. Thus, they are considered a promising stem cell source for therapeutic use. Here, we describe a method for production of good manufacturing practice-grade human UCB-MSCs for therapeutic use. The obtained UCB-MSCs are free of allogenous or xenogenous proteins. In addition, these MSCs could maintain the MSC phenotype in long-term culture. PMID:25239529

  15. Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)

    NASA Astrophysics Data System (ADS)

    Ražem, D.; Katušin-Ražem, B.; Starčević, M.; Galeković, B.

    The microbiological quality of many raw materials used in the manufacture of pharmaceutical and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed.

  16. Performance-based risk-sharing arrangements-good practices for design, implementation, and evaluation: report of the ISPOR good practices for performance-based risk-sharing arrangements task force.

    PubMed

    Garrison, Louis P; Towse, Adrian; Briggs, Andrew; de Pouvourville, Gerard; Grueger, Jens; Mohr, Penny E; Severens, J L Hans; Siviero, Paolo; Sleeper, Miguel

    2013-01-01

    There is a significant and growing interest among both payers and producers of medical products for agreements that involve a "pay-for-performance" or "risk-sharing" element. These payment schemes-called "performance-based risk-sharing arrangements" (PBRSAs)-involve a plan by which the performance of the product is tracked in a defined patient population over a specified period of time and the amount or level of reimbursement is based on the health and cost outcomes achieved. There has always been considerable uncertainty at product launch about the ultimate real-world clinical and economic performance of new products, but this appears to have increased in recent years. PBRSAs represent one mechanism for reducing this uncertainty through greater investment in evidence collection while a technology is used within a health care system. The objective of this Task Force report was to set out the standards that should be applied to "good practices"-both research and operational-in the use of a PBRSA, encompassing questions around the desirability, design, implementation, and evaluation of such an arrangement. This report provides practical recommendations for the development and application of state-of-the-art methods to be used when considering, using, or reviewing PBRSAs. Key findings and recommendations include the following. Additional evidence collection is costly, and there are numerous barriers to establishing viable and cost-effective PBRSAs: negotiation, monitoring, and evaluation costs can be substantial. For good research practice in PBRSAs, it is critical to match the appropriate study and research design to the uncertainties being addressed. Good governance processes are also essential. The information generated as part of PBRSAs has public good aspects, bringing ethical and professional obligations, which need to be considered from a policy perspective. The societal desirability of a particular PBRSA is fundamentally an issue as to whether the cost of

  17. Onsite Distributed Generation Systems For Laboratories, Laboratories for the 21st Century: Best Practices (Brochure)

    SciTech Connect

    Not Available

    2011-09-01

    This guide provides general information on implementing onsite distributed generation systems in laboratory environments. Specific technology applications, general performance information, and cost data are provided to educate and encourage laboratory energy managers to consider onsite power generation or combined heat and power (CHP) systems for their facilities. After conducting an initial screening, energy managers are encouraged to conduct a detailed feasibility study with actual cost and performance data for technologies that look promising. Onsite distributed generation systems are small, modular, decentralized, grid-connected, or off-grid energy systems. These systems are located at or near the place where the energy is used. These systems are also known as distributed energy or distributed power systems. DG technologies are generally considered those that produce less than 20 megawatts (MW) of power. A number of technologies can be applied as effective onsite DG systems, including: (1) Diesel, natural gas, and dual-fuel reciprocating engines; (2) Combustion turbines and steam turbines; (3) Fuel cells; (4) Biomass heating; (5) Biomass combined heat and power; (6) Photovoltaics; and (7) Wind turbines. These systems can provide a number of potential benefits to an individual laboratory facility or campus, including: (1) High-quality, reliable, and potentially dispatchable power; (2) Low-cost energy and long-term utility cost assurance, especially where electricity and/or fuel costs are high; (3) Significantly reduced greenhouse gas (GHG) emissions. Typical CHP plants reduce onsite GHG by 40 to 60 percent; (4) Peak demand shaving where demand costs are high; (5) CHP where thermal energy can be used in addition to electricity; (6) The ability to meet standby power needs, especially where utility-supplied power is interrupted frequently or for long periods and where standby power is required for safety or emergencies; and (7) Use for standalone or off

  18. Utilization of the seven principles for good practice in undergraduate education in general chemistry by community college instructors

    NASA Astrophysics Data System (ADS)

    Panther Bishoff, Jennifer

    In recent years, higher education has undergone many changes. The advent of assessment, accountability, and a newfound focus on teaching have required faculty to examine how they are teaching. Administrators and faculty are beginning to recognize that learning is not a "one size fits all" enterprise. To this end, Chickering and Gamson developed an inventory that examined faculty utilization of the Seven Principles of Good Practice in Undergraduate Education. The seven principles included by the authors included faculty-student interaction, cooperative learning, active learning, giving prompt feedback, emphasizing time on task, communicating high expectations, and respecting diverse talents and ways of learning. It was determined by Chickering and Gamson, as well as many other researchers, that these seven principles were hallmarks of successful undergraduate education. Community colleges are important institutions to study, as many students begin their higher education at two-year colleges. Most students are also required to take one or more science classes for their general education requirements; therefore, many students must take at least one general chemistry course. Both community colleges and chemistry are rarely studied in literature, which makes this study important. Community college general chemistry instructors were surveyed using an online version of Chickering and Gamson's Faculty Inventory for the Seven Principles of Good Practice in Undergraduate Education. Responses were analyzed, and it was discovered that not only did instructors utilize the principles to a different extent, but there were also differences between genders as well as between the specific actions related to each principle.

  19. [Comments on routine laboratory data that are of practical use for physicians].

    PubMed

    Honda, Takayuki; Matsuo, Shuji; Masaki, Mitsuru; Harada, Kenu; Takasaki, Tadashi; Nakamura, Fumihiko

    2013-03-01

    Routine laboratory data are not adequately used to follow a patient because medical students are not educated to comprehend them with time series analysis. The Department of Laboratory Medicine can support physicians by adding comments to laboratory data that are of practical use for following a patient. At Shinshu University School of Medicine, routine laboratory data are discussed by time series analysis in a reversed clinicopathological conference(R-CPC). The general status is checked and then the state of each organ is examined using routine laboratory data, and we can obtain much more information about the patient than from physical examinations. In this R-CPC, several specialists in laboratory medicine discussed routine laboratory data of a patient with severe inflammation. It was difficult to diagnose him with a bacterial infection. Elevation of white blood cell count and high C-reactive protein suggested bacterial infection, and decreased platelets showed the possibility of bacteremia. However, he was clinically diagnosed as having multiple trauma without bacterial infection after falling down a mountainside. If routine laboratory data are finely analyzed by specialists in laboratory medicine, physicians can obtain useful information for patient treatment from the Department of Laboratory Medicine. PMID:23785798

  20. Laboratory Medicine Best Practice Guideline: Vitamins A, E and the Carotenoids in Blood

    PubMed Central

    Greaves, Ronda F; Woollard, Gerald A; Hoad, Kirsten E; Walmsley, Trevor A; Johnson, Lambro A; Briscoe, Scott; Koetsier, Sabrina; Harrower, Tamantha; Gill, Janice P

    2014-01-01

    Despite apparent method similarities between laboratories there appear to be confounding factors inhibiting uniform reporting and standardisation of vitamin assays. The Australasian Association of Clinical Biochemists (AACB) Vitamins Working Party, in conjunction with The Royal College of Pathologists of Australasia Quality Assurance Programs, has formulated a guideline to improve performance, reproducibility and accuracy of fat-soluble vitamin results. The aim of the guideline is to identify critical pre-analytical, analytical and post-analytical components of the analysis of vitamins A, E and carotenoids in blood to promote best practice and harmonisation. This best practice guideline has been developed with reference to the Centers for Disease Control and Prevention (CDC) “Laboratory Medicine Best Practices: Developing an Evidence-Based Review and Evaluation Process”. The CDC document cites an evaluation framework for generating best practice recommendations that are specific to laboratory medicine. These 50 recommendations proposed herein, were generated from a comprehensive literature search and the extensive combined experience of the AACB Vitamins Working Party members. They were formulated based on comparison between an impact assessment rating and strength of evidence and were classified as either: (1) strongly recommend, (2) recommend, (3) no recommendation for or against, or (4) recommend against. These best practice recommendations represent the consensus views, in association with peer reviewed evidence of the AACB Vitamins Working Party, towards best practice for the collection, analysis and interpretation of vitamins A, E and carotenoids in blood. PMID:25210208

  1. Good bolting practices

    SciTech Connect

    Van Duyne, D.A.; Brunner, R.G.; Buffington, G.O.; Malovrh, C.A.; Sheridan, M.E. )

    1990-12-01

    This a Reference Manual designed to help solve or prevent bolted joint problems with small bolts and threaded fasteners. It is designed for rapid access for use in the field or office. The manual tells you how to identify and deal with typical problems such as gasket leaks, vibration loosening, fatigue, stress corrosion cracking, and similar concerns. The manual is NOT intended to be a substitute or alternate for existing bolting specifications, Codes, or standards. It can, however, be used as a guideline to consult with engineering when insufficient direction or instructions are given. This Volume 2: Small Bolts and Threaded Fasteners follows the general format which was used for the Large Bolt Manual. This provides a stand-alone document for small bolts and threaded fasteners while presenting some overlapping information for large or small bolts and studs which share a common use such as for gasketed joints. 26 refs.

  2. Compliance of disposal orbits with the French Space Operations Act: The Good Practices and the STELA tool

    NASA Astrophysics Data System (ADS)

    Le Fèvre, C.; Fraysse, H.; Morand, V.; Lamy, A.; Cazaux, C.; Mercier, P.; Dental, C.; Deleflie, F.; Handschuh, D. A.

    2014-01-01

    Space debris mitigation is one objective of the French Space Operations Act (FSOA), in line with Inter-Agency Space Debris Coordination Committee (IADC) recommendations, through the removal of non-operational objects from populated regions. At the end of their mission, space objects are to be placed on orbits that will minimize future hazards to space objects orbiting in the same region. The FSOA, which came into force in 2010, ensures that technical risks associated with space activities are properly mitigated. The Act confers CNES a central support role in providing technical expertise to government on regulations dealing with space operations. In order to address the compliance of disposal orbits with the law technical requirements, CNES draws up Good Practices as well as a dedicated tool, Semi-analytic Tool for End of Life Analysis (STELA). The verification of the criteria of the French Space Operations Act requires long term orbit propagation to evaluate the evolution of the orbital elements over long time scales (up to more than 100 years). The Good Practices define the minimum dynamical model required to compute the orbital evolution with sufficient accuracy, and detail key computation hypotheses such as drag and reflecting areas, drag coefficient, reflectivity coefficient, solar activity, atmospheric density model and so on. They also recommend a methodology adapted to each orbit type (LEO, GEO, GTO) to assess the criteria of the French Space Operations Act. The most recent works have concerned GTO, for which some couplings occur between dynamic perturbations. A small change in the initial conditions or in the estimation of the drag effect will significantly change the entrance conditions in resonance areas and thus the orbital evolution. To cope with this difficulty, a statistical method has been developed. This paper gives an overview of the Good Practices for orbit propagation in LEO, GEO and GTO as well as a brief description of the STELA tool. It

  3. [Good practice in occupational health services: prophylactic care and occupational activation of people with disabilities due to respiratory diseases].

    PubMed

    Wiszniewska, Marta; Tymoszuk, Diana; Lipińska-Ojrzanowska, Agnieszka; Wagrowska-Koski, Ewa; Walusiak-Skorupa, Jolanta

    2013-01-01

    Respiratory diseases are a cause of long-term sickness absence, and even of partial or complete inability to work. This paper presents the first in Poland description of principles of good practice in occupational health service provided for people with respiratory diseases. The issues concerning the certification of the ability to work in this group of patients are discussed. The key-principles of preventive care of workers with obstructive and interstitial lung diseases with particular attention paid to the control of major risk factors are also presented. The importance of possible contraindications for job performance by workers affected by these diseases, as well as the responsibilities of occupational health physicians were highlighted. M PMID:24261254

  4. Optimizing Radiation Safety in the Cardiac Catheterization Laboratory: A Practical Approach.

    PubMed

    Christopoulos, Georgios; Makke, Lorenza; Christakopoulos, Georgios; Kotsia, Anna; Rangan, Bavana V; Roesle, Michele; Haagen, Donald; Kumbhani, Dharam J; Chambers, Charles E; Kapadia, Samir; Mahmud, Ehtisham; Banerjee, Subhash; Brilakis, Emmanouil S

    2016-02-01

    Reducing radiation exposure during cardiovascular catheterization is of paramount importance for both patient and staff safety. Over the years, advances in equipment and application of radiation safety protocols have significantly reduced patient dose and operator exposure. This review examines the current status of radiation protection in the cardiac and vascular catheterization laboratory and summarizes best practices for minimizing radiation exposure. PMID:26526181

  5. Bringing Theory into Practice: A Study of Effective Leadership at Lawrence Livermore National Laboratory

    ERIC Educational Resources Information Center

    Khoury, Anne

    2006-01-01

    Leadership development, a component of HRD, is becoming an area of increasingly important practice for all organizations. When companies such as Lawrence Livermore National Laboratory rely on knowledge workers for success, leadership becomes even more important. This research paper tests the hypothesis that leadership credibility and the courage…

  6. A Simple Laboratory Practical to Illustrate RNA Mediated Gene Interference Using Drosophila Cell Culture

    ERIC Educational Resources Information Center

    Buluwela, Laki; Kamalati, Tahereh; Photiou, Andy; Heathcote, Dean A.; Jones, Michael D.; Ali, Simak

    2010-01-01

    RNA mediated gene interference (RNAi) is now a key tool in eukaryotic cell and molecular biology research. This article describes a five session laboratory practical, spread over a seven day period, to introduce and illustrate the technique. During the exercise, students working in small groups purify PCR products that encode "in vitro"…

  7. An Analysis of Agricultural Mechanics Safety Practices in Agricultural Science Laboratories.

    ERIC Educational Resources Information Center

    Swan, Michael K.

    North Dakota secondary agricultural mechanics instructors were surveyed regarding instructional methods and materials, safety practices, and equipment used in the agricultural mechanics laboratory. Usable responses were received from 69 of 89 instructors via self-administered mailed questionnaires. Findings were consistent with results of similar…

  8. Enhancing the Student Experience of Laboratory Practicals through Digital Video Guides

    ERIC Educational Resources Information Center

    Croker, Karen; Andersson, Holger; Lush, David; Prince, Rob; Gomez, Stephen

    2010-01-01

    Laboratory-based learning allows students to experience bioscience principles first hand. In our experience, practical content and equipment may have changed over time, but teaching methods largely remain the same, typically involving; whole class introduction with a demonstration, students emulating the demonstration in small groups, gathering…

  9. Integration of Pharmacy Practice and Pharmaceutical Analysis: Quality Assessment of Laboratory Performance.

    ERIC Educational Resources Information Center

    McGill, Julian E.; Holly, Deborah R.

    1996-01-01

    Laboratory portions of courses in pharmacy practice and pharmaceutical analysis at the Medical University of South Carolina are integrated and coordinated to provide feedback on student performance in compounding medications. Students analyze the products they prepare, with early exposure to compendia requirements and other references. Student…

  10. Effectiveness of practices to reduce blood culture contamination: A Laboratory Medicine Best Practices systematic review and meta-analysis☆

    PubMed Central

    Snyder, Susan R.; Favoretto, Alessandra M.; Baetz, Rich Ann; Derzon, James H.; Madison, Bereneice M.; Mass, Diana; Shaw, Colleen S.; Layfield, Christopher D.; Christenson, Robert H.; Liebow, Edward B.

    2015-01-01

    Objectives This article is a systematic review of the effectiveness of three practices for reducing blood culture contamination rates: venipuncture, phlebotomy teams, and prepackaged preparation/collection (prep) kits. Design and methods The CDC-funded Laboratory Medicine Best Practices Initiative systematic review methods for quality improvement practices were used. Results Studies included as evidence were: 9 venipuncture (vs. versus intravenous catheter), 5 phlebotomy team; and 7 prep kit. All studies for venipuncture and phlebotomy teams favored these practices, with meta-analysis mean odds ratios for venipuncture of 2.69 and phlebotomy teams of 2.58. For prep kits 6 studies’ effect sizes were not statistically significantly different from no effect (meta-analysis mean odds ratio 1.12). Conclusions Venipuncture and the use of phlebotomy teams are effective practices for reducing blood culture contamination rates in diverse hospital settings and are recommended as evidence-based “best practices” with high overall strength of evidence and substantial effect size ratings. No recommendation is made for or against prep kits based on uncertain improvement. PMID:22709932

  11. Conditions for building a community of practice in an advanced physics laboratory

    NASA Astrophysics Data System (ADS)

    Irving, Paul W.; Sayre, Eleanor C.

    2014-06-01

    We use the theory of communities of practice and the concept of accountable disciplinary knowledge to describe how a learning community develops in the context of an upper-division physics laboratory course. The change in accountable disciplinary knowledge motivates students' enculturation into a community of practice. The enculturation process is facilitated by four specific structural features of the course and supported by a primary instructional choice. The four structural features are "paucity of instructor time," "all in a room together," "long and difficult experiments," and "same experiments at different times." The instructional choice is the encouragement of the sharing and development of knowledge and understanding by the instructor. The combination of the instructional choice and structural features promotes the development of the learning community in which students engage in authentic practices of a physicist. This results in a classroom community that can provide students with the opportunity to have an accelerated trajectory towards being a more central participant of the community of a practice of physicists. We support our claims with video-based observations of laboratory classroom interactions and individual, semistructured interviews with students about their laboratory experiences and physics identity.

  12. Performance evaluation tests of new laboratory procedures or devices: practical reporting criteria.

    PubMed

    Bridson, E

    1993-06-01

    The publication of papers reporting evaluations of new laboratory procedures and devices has increased rapidly in recent years. As more commercial systems emerge in the market place, and laboratory-based systems disappear, the potential user of the new system turns to his peers for opinions about the function of such systems. Unfortunately, many published reports lack statistical guidance and the reader is too often faced with a recitative about percentage differences and probabilities of significance, frequently reported on unacceptably small sample numbers. This communication offers guidance to those seeking to produce evaluation reports that will be of practical value to others. PMID:8219922

  13. Practicing biology: Undergraduate laboratory research, persistence in science, and the impact of self-efficacy beliefs

    NASA Astrophysics Data System (ADS)

    Berkes, Elizabeth

    As undergraduate laboratory research internships become more popular and universities devote considerable resources towards promoting them, it is important to clarify what students specifically gain through involvement in these experiences and it is important to understand their impact on the science pipeline. By examining recent findings describing the primary benefits of undergraduate research participation, along with self-efficacy theory, this study aims to provide more explanatory power to the anecdotal and descriptive accounts regarding the relationship between undergraduate research experiences and interest in continuing in science. Furthermore, this study characterizes practices that foster students' confidence in doing scientific work with detailed description and analysis of the interactions of researchers in a laboratory. Phase 1 of the study, a survey of undergraduate biology majors (n=71) at a major research university, investigates the relationships among participation in biology laboratory research internships, biology laboratory self-efficacy strength, and interest in persisting in science. Phase 2 of the study, a two-year investigation of a university biology research laboratory, investigates how scientific communities of practice develop self-efficacy beliefs. The findings suggest that participation in lab internships results in increased interest in continuing in life science/biology graduate school and careers. They also suggest that a significant proportion of that interest is related to the students' biology laboratory self-efficacy. The findings of this study point to two primary ways that undergraduate research participation might work to raise self-efficacy strength. First, university research laboratory communities can provide students with a variety of resources that scaffold them into biology laboratory mastery experiences. Second, university research laboratory communities can provide students with coping and mastery Discourse models

  14. [What is good at the laboratory medical technologist in a medium scale hospital in a time of disaster?].

    PubMed

    Takeura, Hisashi

    2011-02-01

    Medical institutes need to prepare for earthquake or severe disasters which may happen at some future date and need to take countermeasures for those situations. Also our laboratory must do the same things. New medical center will be open in March, 2011. At the same time, this hospital will be registered as the one of the centers which contend with disasters to follow the infrastructure outline of disaster caring hospitals of Osaka prefecture. PMID:21476299

  15. Good manufacturing practice production of [68Ga]Ga-ABY-025 for HER2 specific breast cancer imaging

    PubMed Central

    Velikyan, Irina; Wennborg, Anders; Feldwisch, Joachim; Lindman, Henrik; Carlsson, Jörgen; Sörensen, Jens

    2016-01-01

    Therapies targeting human epidermal growth factor receptor type 2 (HER2) have revolutionized breast cancer treatment, but require invasive biopsies and rigorous histopathology for optimal patient stratification. A non-invasive and quantitative diagnostic method such as positron emission tomography (PET) for the pre-therapeutic determination of the presence and density of the HER2 would significantly improve patient management efficacy and treatment cost. The essential part of the PET methodology is the production of the radiopharmaceutical in compliance with good manufacturing practice (GMP). The use of generator produced positron emitting 68Ga radionuclide would provide worldwide accessibility of the agent. GMP compliant, reliable and highly reproducible production of [68Ga]Ga-ABY-025 with control over the product peptide concentration and amount of radioactivity was accomplished within one hour. Two radiopharmaceuticals were developed differing in the total peptide content and were validated independently. The specific radioactivity could be kept similar throughout the study, and it was 6-fold higher for the low peptide content radiopharmaceutical. Intrapatient comparison of the two peptide doses allowed imaging optimization. The high peptide content decreased the uptake in healthy tissue, in particular liver, improving image contrast. The later imaging time points enhanced the contrast. The combination of high peptide content radiopharmaceutical and whole-body imaging at 2 hours post injection appeared to be optimal for routine clinical use. PMID:27186441

  16. Bioprocessing of plant-derived virus-like particles of Norwalk virus capsid protein under current Good Manufacture Practice regulations

    PubMed Central

    Lai, Huafang; Chen, Qiang

    2012-01-01

    Despite the success in expressing a variety of subunit vaccine proteins in plants and the recent stride in improving vaccine accumulation levels by transient expression systems, there is still no plant-derived vaccine that has been licensed for human use. The lack of commercial success of plant-made vaccines lies in several technical and regulatory barriers that remain to be overcome. These challenges include the lack of scalable downstream processing procedures, the uncertainty of regulatory compliance of production processes, and the lack of demonstration of plant-derived products that meet the required standards of regulatory agencies in identity, purity, potency and safety. In this study, we addressed these remaining challenges and successfully demonstrate the ability of using plants to produce a pharmaceutical grade Norwalk virus (NV) vaccine under current Good Manufacture Practice (cGMP) guidelines at multiple gram scales. Our results demonstrate that an efficient and scalable extraction and purification scheme can established for processing virus-like particles (VLP) of NV capsid protein (NVCP). We successfully operated the upstream and downstream NVCP production processes under cGMP regulations. Furthermore, plant-derived NVCP VLP demonstrates the identity, purity, potency and safety that meet the preset release specifications. This material is being tested in a Phase I human clinical trial. This research provides the first report of producing a plant-derived vaccine at scale under cGMP regulations in an academic setting and an important step for plant-produced vaccines to become a commercial reality. PMID:22134876

  17. Health physics manual of good practices for reducing radiation exposure to levels that are as low as reasonably achievable (ALARA)

    SciTech Connect

    Herrington, W.N.; Higby, D.P.; Kathren,., R.L.; Merwin, S.E.; Stoetzel, G.A.

    1988-06-01

    A primary objective of the US Department of Energy (DOE) health physics and radiation protection program has been to limit radiation exposures to those levels that are as low as reasonably achievable (ALARA). As a result, the ALARA concept developed into a program and a set of operational principles to ensure that the objective was consistently met. Implementation of these principles required that a guide be produced. The original ALARA guide was issued by DOE in 1980 to promote improved understanding of ALARA concepts within the DOE community and to assist those responsible for operational ALARA activities in attaining their goals. Since 1980, additional guidance has been published by national and international organizations to provide further definition and clarification to ALARA concepts. As basic ALARA experience increased, the value and role of the original guide prompted the DOE Office of Nuclear Safety (ONS) to support a current revision. The revised manual of good practices includes six sections: 1.0 Introduction, 2.0 Administration, 3.0 Optimization, 4.0 Setting and Evaluating ALARA Goals, 5.0 Radiological Design, and 6.0 Conduct of Operations. The manual is directed primarily to contractor and DOE staff who are responsible for conduct and overview of radiation protection and ALARA programs at DOE facilities. The intent is to provide sufficient guidance such that the manual, if followed, will ensure that radiation exposures are maintained as low as reasonably achievable and will establish the basis for a formally structured and auditable program. 118 refs., 16 figs., 3 tabs.

  18. Cost-effectiveness analysis alongside clinical trials II-An ISPOR Good Research Practices Task Force report.

    PubMed

    Ramsey, Scott D; Willke, Richard J; Glick, Henry; Reed, Shelby D; Augustovski, Federico; Jonsson, Bengt; Briggs, Andrew; Sullivan, Sean D

    2015-03-01

    Clinical trials evaluating medicines, medical devices, and procedures now commonly assess the economic value of these interventions. The growing number of prospective clinical/economic trials reflects both widespread interest in economic information for new technologies and the regulatory and reimbursement requirements of many countries that now consider evidence of economic value along with clinical efficacy. As decision makers increasingly demand evidence of economic value for health care interventions, conducting high-quality economic analyses alongside clinical studies is desirable because they broaden the scope of information available on a particular intervention, and can efficiently provide timely information with high internal and, when designed and analyzed properly, reasonable external validity. In 2005, ISPOR published the Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force report. ISPOR initiated an update of the report in 2014 to include the methodological developments over the last 9 years. This report provides updated recommendations reflecting advances in several areas related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members note that trials should be designed to evaluate effectiveness (rather than efficacy) when possible, should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. An incremental analysis should be conducted with an intention-to-treat approach, complemented by relevant subgroup analyses. Uncertainty should be characterized. Articles should adhere to established standards for reporting results of cost-effectiveness analyses. Economic studies alongside trials are complementary to other evaluations (e.g., modeling studies) as information for decision

  19. The Clue to Minimizing the Developer-User Divide by Good Practice in Earth and Space Science Informatics

    NASA Astrophysics Data System (ADS)

    Messerotti, M.

    2009-04-01

    Earth and Space Science research, as well as many other disciplines, can nowadays benefit from advanced data handling techniques and tools capable to significantly relieve the scientist of the burden of data search, retrieval, visualization and manipulation, and to exploit the data information content. Some typical examples are Virtual Observatories (VO) specific to a variety of sub-disciplines but anyway interlinked, a feature intrinsic to the VO architecture, Virtual Globes as advanced 3D selection and visualization interfaces to distributed data repositories, and the Global Earth Observation System of Systems. These information systems are proving also effective in education and outreach activities as they are usable via web interfaces to give access to, to display and to download nonhomogeneous datasets in order to raise the awareness of the students and the public on the relevant disciplines. Despite of that, all of this effective machineries are still poorly used both by the scientific community and by the community active in education and outreach. All such infrastructures are designed and developed according to the state-of-the-art information and computer engineering techniques and are provided with top features such as ontology- and semantics-based data management, and advanced unified web-based interfaces. Anyway, a careful analysis of the issue mentioned above indicates a key aspect that play a major role, i.e., the inadequate interaction with the users' communities during the design, the development, the deployment and the test phases. Even the best technical tool can appear inadequate to the final user when it does not meet the user's requirements in terms of achievable goals and use friendliness. In this work, we consider the user-side features to be taken into account for the optimum exploitation of an information system in the framework of the interaction among the design engineers and the target communities towards the setting of a good practice

  20. [Procedural guidelines. Good practice procedures for acquisition and preparation of cryopreserved human amniotic membranes from donor placentas].

    PubMed

    Hahn, A; Thanos, M; Reinhard, T; Seitz, B; Steuhl, K-P; Meller, D

    2010-11-01

    A cornea/tissue bank must have an organizational structure in which responsibility and authority to issue directives are clearly defined. It must also use a documented quality management system on the basis of good practice procedures which is maintained to the current standards. The personnel of a cornea/tissue bank must be present in sufficient numbers and be suitably qualified. A cornea/tissue bank must be in possession of appropriate facilities which are suitable for the main purpose of preparation of cryopreserved human amniotic membranes from donor placentas. All equipment must be designed and maintained corresponding to the intended purpose. Deviations from the stipulated quality and safety standards must give rise to documented investigations which include decisions on options for correctional and preventive measures. Acquisition of donors and tissue sampling must be strictly controlled and documented. This also applies to entry of donor tissue in the cornea/tissue bank. Cryopreserved human amniotic membranes can only be preserved from donors undergoing caesarean section and who did not present any known infection of the abdominal cavity or any systemic blood borne infection. Contamination of media used for cryopreservation of donor placenta must be ruled out at least once. Measures must be taken to keep the risk of contamination as low as possible. Cryopreserved human amniotic membranes from donor placentas can only be released if defined criteria are fulfilled. Any suspicion of severe undesired reactions and events for the recipient of an amniotic membrane transplant must be registered with the authorities. The activities of a cornea/tissue bank must maintain and adapt to the state-of-the-art with respect to scientific progress. PMID:21088951

  1. Knowledge and practices of laboratory workers on standardized antimicrobial susceptibility testing and biosafety practices to prevent the spread of superbugs in Pakistan.

    PubMed

    Ghanchi, Najia K; Khan, Erum; Farooqi, Joveria Q; Fasih, Naima; Dojki, Maqboola; Hughes, Molly A

    2014-09-01

    A cross-sectional survey using structured questionnaire was conducted to assess practices of microbiological laboratories working with pathogens. Forty-eight laboratory workers (50%) agreed that laboratory methods to detect antimicrobial resistance are not standardized in Pakistan, and 6% of the laboratory workers were not aware of the standardization of antimicrobial susceptibility testing in Pakistan. Reported rates of awareness regarding the role of waste disposal, disinfection, and handwashing in limiting the spread of antimicrobial resistance were 75%, 42%, and 81%, respectively. Our results provide baseline data for planning programs to train, supervise, and improve the operational quality of microbiological laboratories nationwide to prevent the spread of superbugs. PMID:25179341

  2. [A Perspective on Innovation for Efficient Medical Practice in View of Undergraduate and Postgraduate Education and Training in Laboratory Medicine].

    PubMed

    Kawai, Tadashi

    2015-10-01

    Continuous advances in medical laboratory technology have driven major changes in the practice of laboratory medicine over the past two decades. The importance of the overall quality of a medical laboratory has been ever-increasing in order to improve and ensure the quality and safety of clinical practice by physicians in any type of medical facility. Laboratory physicians and professional staff should challenge themselves more than ever in various ways to cooperate and contribute with practicing physicians for the appropriate utilization of laboratory testing. This will certainly lead to a decrease in inappropriate or unnecessary laboratory testing, resulting in reducing medical costs. In addition, not only postgraduate, but also undergraduate medical education/training systems must be markedly innovated, considering recent rapid progress in electronic information and communication technologies. PMID:26897851

  3. Comparison of Aseptic Compounding Errors Before and After Modified Laboratory and Introductory Pharmacy Practice Experiences

    PubMed Central

    Owora, Arthur H.; Kirkpatrick, Alice E.

    2015-01-01

    Objective. To determine whether aseptic compounding errors were reduced at the end of the third professional year after modifying pharmacy practice laboratories and implementing an institutional introductory pharmacy practice experience (IPPE). Design. An aseptic compounding laboratory, previously occurring during the third-year spring semester, was added to the second-year spring semester. An 80-hour institutional IPPE was also added in the summer between the second and third years. Instructors recorded aseptic compounding errors using a grading checklist for second-year and third-year student assessments. Third-year student aseptic compounding errors were assessed prior to the curricular changes and for 2 subsequent years for students on the Oklahoma City and Tulsa campuses of the University of Oklahoma. Assessment. Both third-year cohorts committed fewer aseptic technique errors than they did during their second years, and the probability was significantly lower for students on the Oklahoma City campus. The probability of committing major aseptic technique errors was significantly lower for 2 consecutive third-year cohorts after the curricular changes. Conclusion. The addition of second-year aseptic compounding laboratory experiences and third-year institutional IPPE content reduced instructor-assessed errors at the end of the third year. PMID:26889070

  4. Practice-based research networks: the laboratories of primary care research.

    PubMed

    Lindbloom, Erik J; Ewigman, Bernard G; Hickner, John M

    2004-04-01

    Medical research has traditionally been based in academic centers, and the findings are frequently not applicable in community primary care settings. The result is a large gap between the possible and the practical in delivering high-quality primary medical care in the United States. Practice-based research networks (PBRNs), laboratories for primary care clinical research, are the appropriate vehicles for uniting the worlds of community primary care practice and clinical research. Although they have received little attention in the mainstream of clinical and health services research, PBRNs have already reported a variety of findings useful for primary care providers, and these networks have helped to identify key issues in healthcare delivery that affect important outcomes. In this report, we outline the rationale for and history of PBRNs. We describe the organization and work of several productive PBRNs, giving examples of their studies that have changed the standards of modern primary care practice. Finally, we describe a developing electronic process for identifying research questions obtained directly from primary care providers that can be used to focus the national primary care research agenda on questions of clinical relevance and importance. As electronic technologies are fully developed and tested, they will facilitate communication between clinicians and researchers, thereby improving the effectiveness and efficiency of practice-based research. PMID:15026664

  5. Can a Point-of-Care Troponin I Assay be as Good as a Central Laboratory Assay? A MIDAS Investigation

    PubMed Central

    Diercks, Deborah; Birkhahn, Robert; Singer, Adam J.; Hollander, Judd E.; Nowak, Richard; Safdar, Basmah; Miller, Chadwick D.; Peberdy, Mary; Counselman, Francis; Chandra, Abhinav; Kosowsky, Joshua; Neuenschwander, James; Schrock, Jon; Lee-Lewandrowski, Elizabeth; Arnold, William; Nagurney, John

    2016-01-01

    Background We aimed to compare the diagnostic accuracy of the Alere Triage Cardio3 Tropinin I (TnI) assay (Alere, Inc., USA) and the PathFast cTnI-II (Mitsubishi Chemical Medience Corporation, Japan) against the central laboratory assay Singulex Erenna TnI assay (Singulex, USA). Methods Using the Markers in the Diagnosis of Acute Coronary Syndromes (MIDAS) study population, we evaluated the ability of three different assays to identify patients with acute myocardial infarction (AMI). The MIDAS dataset, described elsewhere, is a prospective multicenter dataset of emergency department (ED) patients with suspected acute coronary syndrome (ACS) and a planned objective myocardial perfusion evaluation. Myocardial infarction (MI) was diagnosed by central adjudication. Results The C-statistic with 95% confidence intervals (CI) for diagnosing MI by using a common population (n=241) was 0.95 (0.91-0.99), 0.95 (0.91-0.99), and 0.93 (0.89-0.97) for the Triage, Singulex, and PathFast assays, respectively. Of samples with detectable troponin, the absolute values had high Pearson (RP) and Spearman (RS) correlations and were RP =0.94 and RS=0.94 for Triage vs Singulex, RP =0.93 and RS=0.85 for Triage vs PathFast, and RP =0.89 and RS=0.73 for PathFast vs Singulex. Conclusions In a single comparative population of ED patients with suspected ACS, the Triage Cardio3 TnI, PathFast, and Singulex TnI assays provided similar diagnostic performance for MI. PMID:27374704

  6. Redefinition of gestational diabetes mellitus: implications for laboratory practice in Croatia

    PubMed Central

    Lovrenčić, Marijana Vučić; Honović, Lorena; Kralik, Saša; Matica, Jasminka; Prašek, Manja; Pape-Medvidović, Edita; Ivanišević, Marina; Đelmiš, Josip

    2013-01-01

    An increasing prevalence of gestational diabetes has become a very challenging task in prenatal care worldwide. International Association of Diabetes and Pregnancy Study Groups (IADPSG) has recently issued recommendations on the diagnosis and classification of hyperglycaemia in pregnancy. These recommendations, the first to provide harmonised, evidence-based criteria for the diagnosis and classification of diabetes in pregnancy, are currently being discussed and accepted worldwide by the relevant authorities. As the acceptance of the proposed criteria has major implications for both clinical and laboratory settings, a concerted action towards necessary changes in practice has to be carefully planned and adjusted to national health-care specificities. IADPSG criteria have been strongly advocated by the Croatian Perinatology Society, resulting in a new strategy for the detection and diagnosis of hyperglycaemic disorders in pregnancy. To address the respective laboratory requirements, in April 2012, the Croatian Chamber of Medical Biochemists appointed a Working Group to provide a standardised procedure for the diagnosis of gestational diabetes, applicable to all laboratories involved in prenatal care, in both primary and specialised health-care facilities. In this paper we discuss key laboratory-related issues regarding succesful implementation of the IADPSG criteria in Croatia. PMID:23457760

  7. Redefinition of gestational diabetes mellitus: implications for laboratory practice in Croatia.

    PubMed

    Lovrencić, Marijana Vucić; Honović, Lorena; Kralik, Sasa; Matica, Jasminka; Prasek, Manja; Pape-Medvidović, Edita; Ivanisević, Marina; Delmis, Josip

    2013-01-01

    An increasing prevalence of gestational diabetes has become a very challenging task in prenatal care worldwide. International Association of Diabetes and Pregnancy Study Groups (IADPSG) has recently issued recommendations on the diagnosis and classification of hyperglycaemia in pregnancy. These recommendations, the first to provide harmonised, evidence-based criteria for the diagnosis and classification of diabetes in pregnancy, are currently being discussed and accepted worldwide by the relevant authorities. As the acceptance of the proposed criteria has major implications for both clinical and laboratory settings, a concerted action towards necessary changes in practice has to be carefully planned and adjusted to national health-care specificities. IADPSG criteria have been strongly advocated by the Croatian Perinatology Society, resulting in a new strategy for the detection and diagnosis of hyperglycaemic disorders in pregnancy. To address the respective laboratory requirements, in April 2012, the Croatian Chamber of Medical Biochemists appointed a Working Group to provide a standardised procedure for the diagnosis of gestational diabetes, applicable to all laboratories involved in prenatal care, in both primary and specialised health-care facilities. In this paper we discuss key laboratory-related issues regarding succesful implementation of the IADPSG criteria in Croatia. PMID:23457760

  8. Developing and Optimising the Use of Logic Models in Systematic Reviews: Exploring Practice and Good Practice in the Use of Programme Theory in Reviews

    PubMed Central

    Kneale, Dylan; Thomas, James; Harris, Katherine

    2015-01-01

    Background Logic models are becoming an increasingly common feature of systematic reviews, as is the use of programme theory more generally in systematic reviewing. Logic models offer a framework to help reviewers to ‘think’ conceptually at various points during the review, and can be a useful tool in defining study inclusion and exclusion criteria, guiding the search strategy, identifying relevant outcomes, identifying mediating and moderating factors, and communicating review findings. Methods and Findings In this paper we critique the use of logic models in systematic reviews and protocols drawn from two databases representing reviews of health interventions and international development interventions. Programme theory featured only in a minority of the reviews and protocols included. Despite drawing from different disciplinary traditions, reviews and protocols from both sources shared several limitations in their use of logic models and theories of change, and these were used almost unanimously to solely depict pictorially the way in which the intervention worked. Logic models and theories of change were consequently rarely used to communicate the findings of the review. Conclusions Logic models have the potential to be an aid integral throughout the systematic reviewing process. The absence of good practice around their use and development may be one reason for the apparent limited utility of logic models in many existing systematic reviews. These concerns are addressed in the second half of this paper, where we offer a set of principles in the use of logic models and an example of how we constructed a logic model for a review of school-based asthma interventions. PMID:26575182

  9. Patterns and processes of nutrient transfers from land to water: a catchment approach to evaluate Good Agricultural Practice in Ireland

    NASA Astrophysics Data System (ADS)

    Mellander, P.-E.; Melland, A. R.; Shortle, G.; Wall, D.; Mechan, S.; Buckley, C.; Fealy, R.; Jordan, P.

    2009-04-01

    Eutrophication of fresh, transitional and coastal waters by excessive nutrient inputs is one of the most widespread water quality problems in developed countries. Sources of nutrient nitrogen (N) and phosphorus (P) can come from a multiplicity of sources and be dependent on numerous hydrological controls from catchments with both urban and agricultural landuses. Aquatic impacts are widely reported as a result of excessive nutrient transfers from land to water and include changes in ecological integrity and loss of amenity. In the European Union, the Water Framework Directive (WFD) and associated Directives are the key structures with which member states must develop national and often trans-national polices to deal with issues of water resources management. The linked Nitrates Directive is particularly concerned with integrating sustainable agriculture and good water quality objectives and is written into national polices. In Ireland this policy is the Nitrates Directive National Action Programme (NAP), Statutory Instruction 378, Good Agricultural Practise regulation, and amongst other things, sets targets and limits on the use of organic and inorganic fertilisers, soil fertility and slurry/fertiliser spreading and cultivation times. To evaluate the effectiveness of this policy, Teagasc, the Irish Agriculture and Food Development Authority, is undertaking a catchment scale audit on sources, sinks, and changes in nutrient use and export over several years. The Agricultural Catchments Programme is based on a science-stakeholder-management partnership to generate knowledge and specifically to protect water quality from nitrogen and phosphorus transfers within the constraints of the requirements of modern Irish agricultural practises. Eight catchments of 5-12 km2 have been selected for the programme to represent a range of agricultural intensities and vulnerabilities to nitrogen and phosphorus loss including catchments that are situated on permeable and impermeable

  10. Regulatory affairs and biotechnology in Europe: III. Introduction into good regulatory practice--validation of virus removal and inactivation.

    PubMed

    Trijzelaar, B

    1993-01-01

    This paper provides for an overview on the practical consequences of the EC guideline (III/8115/89): Validation of Virus Removal and Inactivation. This guideline can only be used as a blueprint in combination with other specific guidelines, especially those concerned with EC recommendations during production and quality control for various biotech products. A potential risk associated with the production and use of biological products is viral contamination. This contamination may be present in the source material, eg. human blood, human or animal tissues, cell banks, or introduced in the manufacturing process through the use of animal sera (eg. foetal calf serum or trypsin) in cell culture supernatant. The objectives of validation are to establish--ideally both qualitatively as well as quantitatively--the overall level of virus clearance. Evidence of viral clearance must be obtained in all stages of purification and adequate viral removal and/or inactivation must be proven. The method used when validating viral removal and/or inactivation is by challenging the system through the deliberate addition ("spiking") of significant amounts of virus into the crude material to be purified and to different fractions obtained during the various purification stages. Removal or inactivation of the virus during the subsequent stages of purification and/or inactivation is thereafter determined. Such a quality system is by no means a simple one: it is estimated that in some production lines around 600 Standard Operating Procedures are necessary to guarantee the quality and the safety of the desired biotechnological product. Small companies will probably not be able to perform all procedures needed for obtaining the desired quality of the product. Then, external laboratories may take over a part of the Part II development requirements, which may not be representative for the total of internal Quality Assurance. New developments in the production and quality control of

  11. Partnerships between secondary/elementary science teachers and laboratory-based scientists: Delineating best practices

    NASA Astrophysics Data System (ADS)

    Henderson, Sandra

    Given the high probability of national and federal research laboratories continuing to sponsor science education partnerships between their staff and classroom science teachers and the dearth of research in this area, this study set out to delineate best practices associated with such partnerships for the purpose of increasing the effectiveness of future partnerships. This investigation critically examined two science education partnerships at selected federal research laboratories over the course of summer workshops and the subsequent academic year. Sources of data included interviews, workshop observations, electronic mail communication, written program evaluations, and casual conversation. A unique feature of this research was the inclusion of all representative groups including program administrators, laboratory scientists, and the participating classroom teachers. By capturing the perspectives of all participant groups, this research was able to present a complete portrayal of science education partnerships at two national research laboratories. The longitudinal nature of this investigation allowed for all components of each program (e.g. planning, organization, implementation, evaluation, and follow-up) to be included in the research. The determination of best practices in science education partnerships provided the framework for this research which clearly showed the underlying importance of the need for all participants to understand the goals and what is expected of them before the program gets underway. To be achievable, individual and programmatic expectations must be in alignment with the overall goals of a program. To be attainable, the goals must be understood by all and provide a framework for the expectations. Without a clear and shared vision of a programs direction, goals and expectations are not likely to be fulfilled. The common thread for each of these components is communication and its importance during all stages of a program cannot be

  12. In vitro diagnostic company recalls and medical laboratory practices: an Italian case

    PubMed Central

    Lippi, Giuseppe; Salvagno, Gian Luca; Brocco, Giorgio; Guidi, Gian Cesare

    2015-01-01

    Introduction In vitro human diagnostic (IVD) company recalls are a common practice aimed to either minimize a potential error or eliminate an existing failure. In this case report, we aim to provide a critical analysis of a recent IVD recall and to provide a practical framework about what to do when an IVD company recalls product(s) based on the International Organization for Standardization - ISO 15189:2012 standard. Case report In 2014, Abbott Laboratories® (Green Oaks, IL) published an urgent field safety notice regarding a product recall (Architect Intact parathyroid hormone (PTH) Assay List Number 8K25) with immediate action required. The IVD company explained the reasons for the recall as follows: i) Abbott has confirmed that a performance shift in the Architect Intact PTH assay has the potential to generate falsely elevated results on patient samples; ii) results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. This issue may also impact established Architect Intact PTH reference ranges; iii) the magnitude of shift averages approximately 13% to 45%; iv) Abbott Architect Intact PTH controls do not detect the shift; and v) all current reagent, calibrator, and control inventory are impacted. The recall could have resulted in ~40,000 inaccurate laboratory tests reported by 18 laboratories from Italy (Lombardy region). Conclusion IVD company recalls have a serious impact on the patient safety and require a thorough investigation and responsible approach to minimize the possible damage. Medical laboratories accredited according to the ISO 15189 standard have procedures in place to manage such situations and ensure that patient safety is maintained when such recalls are issued. PMID:26110040

  13. Bovine cysticercosis in slaughtered cattle as an indicator of Good Agricultural Practices (GAP) and epidemiological risk factors.

    PubMed

    Rossi, Gabriel Augusto Marques; Hoppe, Estevam Guilherme Lux; Mathias, Luis Antonio; Martins, Ana Maria Centola Vidal; Mussi, Leila Aparecida; Prata, Luiz Francisco

    2015-03-01

    This study focused on estimating the economic losses resulting from cysticercosis at beef cattle farms that supply an export slaughterhouse located in the state of São Paulo, Brazil, and to identify the epidemiological risks factors involved in the disease to ascertain if these farms adopt Good Agricultural Practices (GAP). To this, we used data recorded in 2012 by Brazil's Federal Inspection Service (SIF) on the daily occurrence of the disease, according to the farm from which the animals originated. In addition, the associated risk factors were determined based on a case-control study at 48 farms. Cysticercosis was detected in 2.26% (95% CI 2.2-2.33) of the 190,903 bovines supplied by 556 farms in the following four states: 2.92% (95% CI 2.83-3.03) in São Paulo, 1.81% (95% CI 1.71-1.93) in Minas Gerais, 0.71% (95% CI 0.6-0.82) in Goiás and 1.11% (95% CI 0.79-1.57) in Mato Grosso do Sul, with significant differences in the epidemiological indices of these states. Cysticercosis was detected at 58.45% (95% CI 54.36-62.55) of the farms of this study, representing estimated economic losses of US$312,194.52 for the farmers. Lower prevalence of this disease were found at the farms qualified for exports to the European Union, indicating a statistically significant difference from those not qualified to export to Europe. The access of cattle to non-controlled water sources, as well as sport fishing activities near the farms, was identified as risk factors. Cysticercosis causes considerable losses in Brazil's beef supply chain, with lower prevalence appearing only at farms qualified to export to the European Union. As for the access of cattle to non-controlled water sources, this is an indication that GAP are not implemented by some farms, demonstrating the violation of international agreements by the industry and the farms. PMID:25631403

  14. Practical guidelines for setting up neurosurgery skills training cadaver laboratory in India.

    PubMed

    Suri, Ashish; Roy, Tara Sankar; Lalwani, Sanjeev; Deo, Rama Chandra; Tripathi, Manjul; Dhingra, Renu; Bhardwaj, Daya Nand; Sharma, Bhawani Shankar

    2014-01-01

    Though the necessity of cadaver dissection is felt by the medical fraternity, and described as early as 600 BC, in India, there are no practical guidelines available in the world literature for setting up a basic cadaver dissection laboratory for neurosurgery skills training. Hands-on dissection practice on microscopic and endoscopic procedures is essential in technologically demanding modern neurosurgery training where ethical issues, cost constraints, medico-legal pitfalls, and resident duty time restrictions have resulted in lesser opportunities to learn. Collaboration of anatomy, forensic medicine, and neurosurgery is essential for development of a workflow of cadaver procurement, preservation, storage, dissection, and disposal along with setting up the guidelines for ethical and legal concerns. PMID:25033845

  15. An Exploration of Teachers' Narratives: What Are the Facilitators and Constraints Which Promote or Inhibit "Good" Formative Assessment Practices in Schools?

    ERIC Educational Resources Information Center

    Sach, Elizabeth

    2015-01-01

    This paper set out to explore teachers' narratives in order to understand some of the facilitators and constraints which promote or inhibit good formative assessment practices in schools. A "responsive interview" approach was used to probe a small sample of lower and middle school teachers' perceptions of formative assessment.…

  16. Guided by Theory, Informed by Practice: Training and Support for the Good Behavior Game, a Classroom-Based Behavior Management Strategy

    ERIC Educational Resources Information Center

    Poduska, Jeanne M.; Kurki, Anja

    2014-01-01

    Moving evidence-based practices for classroom behavior management into real-world settings is a high priority for education and public health. This article describes the development and use of a model of training and support for the Good Behavior Game (GBG), one of the few preventive interventions shown to have positive outcomes for elementary…

  17. Good practice in mental health care for socially marginalised groups in Europe: a qualitative study of expert views in 14 countries

    PubMed Central

    2012-01-01

    Background Socially marginalised groups tend to have higher rates of mental disorders than the general population and can be difficult to engage in health care. Providing mental health care for these groups represents a particular challenge, and evidence on good practice is required. This study explored the experiences and views of experts in 14 European countries regarding mental health care for six socially marginalised groups: long-term unemployed; street sex workers; homeless; refugees/asylum seekers; irregular migrants and members of the travelling communities. Methods Two highly deprived areas were selected in the capital cities of 14 countries, and experts were interviewed for each of the six marginalised groups. Semi-structured interviews with case vignettes were conducted to explore experiences of good practice and analysed using thematic analysis. Results In a total of 154 interviews, four components of good practice were identified across all six groups: a) establishing outreach programmes to identify and engage with individuals with mental disorders; b) facilitating access to services that provide different aspects of health care, including mental health care, and thus reducing the need for further referrals; c) strengthening the collaboration and co-ordination between different services; and d) disseminating information on services both to marginalised groups and to practitioners in the area. Conclusions Experts across Europe hold similar views on what constitutes good practice in mental health care for marginalised groups. Care may be improved through better service organisation, coordination and information. PMID:22455472

  18. Access to Gender-Sensitive Higher Education in Eastern and Central Europe: Reflections on the CEPES Project "Good Practice in Promoting Gender Equality in Higher Education"

    ERIC Educational Resources Information Center

    Grunberg, Laura

    2005-01-01

    Summarizing the incomplete results of the United Nations Educational and Scientific Organization (UNESCO) program "Good Practice in Promoting Gender Equality in Higher Education," the author asks that any assessment of the progress made in the area of gender-sensitive education take regional specificities into account. The regional environment is…

  19. Navigating the Good Ol' Boys Club: Women, Marginality, and Communities of Practice in a Military Non-Profit Organization

    ERIC Educational Resources Information Center

    Callahan, Jamie L.; Tomaszewski, Lesley

    2007-01-01

    When women work in male-dominated organizations, do they form collaborative networks with other women or do they take on the practices of the male-dominated community they are a part of? In this paper, we explore how female staff and volunteer members participate within a male-dominated non-profit organization. We use communities of practice as a…

  20. The utilization of the seven principles for good practices of full-time and adjunct faculty in teaching health & science in community colleges

    NASA Astrophysics Data System (ADS)

    Musaitif, Linda M.

    Purpose. The purpose of this study was to determine the degree to which undergraduate full-time and adjunct faculty members in the health and science programs at community colleges in Southern California utilize the seven principles of good practice as measured by the Faculty Inventory of the Seven Principles for Good Practice in Undergraduate Education. A second purpose was to compare degree of utilization for gender and class size. Methodology. This is a quantitative study wherein there exists a systematic and mathematical assessment of data gathered through the use of a Likert scale survey to process and determine the mathematical model of the use of the principles by the target population of both full-time and adjunct faculty of health/science programs of community colleges in Southern California. Findings. Examination of the data revealed that both full-time and adjunct faculty members of Southern California community colleges perceive themselves a high degree of utilization of the seven principles of good practice. There was no statistically significant data to suggest a discrepancy between full-time and adjunct professors' perceptions among the utilization of the seven principles. Overall, male faculty members perceived themselves as utilizing the principles to a greater degree than female faculty. Data suggest that faculty with class size 60 or larger showed to utilize the seven principles more frequently than the professors with smaller class sizes. Conclusions. Full-time and adjunct professors of the health and sciences in Southern California community colleges perceive themselves as utilizing the seven principles of good practice to a high degree. Recommendations. This study suggests many recommendations for future research, including the degree to which negative economic factors such as budget cuts and demands affect the utilization of the seven principles. Also recommended is a study comparing students' perceptions of faculty's utilization of the seven

  1. The Usefulness of Clinical-Practice-Based Laboratory Data in Facilitating the Diagnosis of Dengue Illness

    PubMed Central

    Liu, Jien-Wei; Lee, Ing-Kit; Wang, Lin; Chen, Rong-Fu; Yang, Kuender D.

    2013-01-01

    Alertness to dengue and making a timely diagnosis is extremely important in the treatment of dengue and containment of dengue epidemics. We evaluated the complementary role of clinical-practice-based laboratory data in facilitating suspicion/diagnosis of dengue. One hundred overall dengue (57 dengue fever [DF] and 43 dengue hemorrhagic fever [DHF]) cases and another 100 nondengue cases (78 viral infections other than dengue, 6 bacterial sepsis, and 16 miscellaneous diseases) were analyzed. We separately compared individual laboratory variables (platelet count [PC] , prothrombin time [PT], activated partial thromboplastin time [APTT], alanine aminotransferase [ALT], and aspartate aminotransferase [AST]) and varied combined variables of DF and/or DHF cases with the corresponding ones of nondengue cases. The sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) in the diagnosis of DF and/or DHF were measured based on these laboratory variables. While trade-off between sensitivity and specificity, and/or suboptimal PPV/NPV was found at measurements using these variables, prolonged APTT + normal PT + PC < 100 × 109 cells/L had a favorable sensitivity, specificity, PPV, and NPV in diagnosis of DF and/or DHF. In conclusion, these data suggested that prolonged APTT + normal PT + PC < 100 × 109 cells/L is useful in evaluating the likelihood of DF and/or DHF. PMID:24455678

  2. Patterns and processes of nutrient transfers from land to water: a catchment approach to evaluate Good Agricultural Practice in Ireland

    NASA Astrophysics Data System (ADS)

    Mellander, P.-E.; Melland, A. R.; Shortle, G.; Wall, D.; Mechan, S.; Buckley, C.; Fealy, R.; Jordan, P.

    2009-04-01

    Eutrophication of fresh, transitional and coastal waters by excessive nutrient inputs is one of the most widespread water quality problems in developed countries. Sources of nutrient nitrogen (N) and phosphorus (P) can come from a multiplicity of sources and be dependent on numerous hydrological controls from catchments with both urban and agricultural landuses. Aquatic impacts are widely reported as a result of excessive nutrient transfers from land to water and include changes in ecological integrity and loss of amenity. In the European Union, the Water Framework Directive (WFD) and associated Directives are the key structures with which member states must develop national and often trans-national polices to deal with issues of water resources management. The linked Nitrates Directive is particularly concerned with integrating sustainable agriculture and good water quality objectives and is written into national polices. In Ireland this policy is the Nitrates Directive National Action Programme (NAP), Statutory Instruction 378, Good Agricultural Practise regulation, and amongst other things, sets targets and limits on the use of organic and inorganic fertilisers, soil fertility and slurry/fertiliser spreading and cultivation times. To evaluate the effectiveness of this policy, Teagasc, the Irish Agriculture and Food Development Authority, is undertaking a catchment scale audit on sources, sinks, and changes in nutrient use and export over several years. The Agricultural Catchments Programme is based on a science-stakeholder-management partnership to generate knowledge and specifically to protect water quality from nitrogen and phosphorus transfers within the constraints of the requirements of modern Irish agricultural practises. Eight catchments of 5-12 km2 have been selected for the programme to represent a range of agricultural intensities and vulnerabilities to nitrogen and phosphorus loss including catchments that are situated on permeable and impermeable

  3. Recasting a Traditional Laboratory Practical as a "Design-Your-Own Protocol" to Teach a Universal Research Skill

    ERIC Educational Resources Information Center

    Whitworth, David E.

    2016-01-01

    Laboratory-based practical classes are a common feature of life science teaching, during which students learn how to perform experiments and generate/interpret data. Practical classes are typically instructional, concentrating on providing topic- and technique-specific skills, however to produce research-capable graduates it is also important to…

  4. Review of Practices Reported for Preoperative Food and Water Restriction of Laboratory Pigs (Sus scrofa)

    PubMed Central

    Bradbury, A Guenevere; Clutton, R Eddie

    2016-01-01

    The traditionally cited recommendations for the preoperative restriction of food (including bedding) and water in pigs do not appear to be evidence-based. As a preliminary step in elucidating a rationale for and standardizing preoperative food and water restriction (PFWR), this structured review recorded recent reported practices in PFWR in laboratory pigs and its consequences. Medline, Google Scholar and Web of Science databases were searched for recently published (2012 – 2014) recovery surgery procedures in pigs. Information pertaining to PFWR practices, as delineated in the ARRIVE guidelines, was extracted from the 233 articles retrieved. Food withdrawal was described in 73 of the 233 (31%) papers evaluated, bedding withdrawal in 5 articles (2%), and water withholding in 13 publications (6%) papers. Food, bedding, and water withdrawal regimens had a median (range) duration of 12 (4 to 48), 48 (48 to 72), and 12 (2 to 12) h, respectively. Compared with other types of procedures, articles describing gastrointestinal or abdominal surgery were more likely to report fasting regimes. Liquid diets were described in 11 of the 233 (5%) publications evaluated. Adverse effects of PFWR effects were not reported. These data reveal considerable variation in PFWR practices. The stress of fasting coupled with the absence of evidence for current recommendations makes the rationale and standards for PFWR in pigs worthy of further study. PMID:26817978

  5. Review of Practices Reported for Preoperative Food and Water Restriction of Laboratory Pigs (Sus scrofa).

    PubMed

    Bradbury, A Guenevere; Clutton, R Eddie

    2016-01-01

    The traditionally cited recommendations for the preoperative restriction of food (including bedding) and water in pigs do not appear to be evidence-based. As a preliminary step in elucidating a rationale for and standardizing preoperative food and water restriction (PFWR), this structured review recorded recent reported practices in PFWR in laboratory pigs and its consequences. Medline, Google Scholar and Web of Science databases were searched for recently published (2012 - 2014) recovery surgery procedures in pigs. Information pertaining to PFWR practices, as delineated in the ARRIVE guidelines, was extracted from the 233 articles retrieved. Food withdrawal was described in 73 of the 233 (31%) papers evaluated, bedding withdrawal in 5 articles (2%), and water withholding in 13 publications (6%) papers. Food, bedding, and water withdrawal regimens had a median (range) duration of 12 (4 to 48), 48 (48 to 72), and 12 (2 to 12) h, respectively. Compared with other types of procedures, articles describing gastrointestinal or abdominal surgery were more likely to report fasting regimes. Liquid diets were described in 11 of the 233 (5%) publications evaluated. Adverse effects of PFWR effects were not reported. These data reveal considerable variation in PFWR practices. The stress of fasting coupled with the absence of evidence for current recommendations makes the rationale and standards for PFWR in pigs worthy of further study. PMID:26817978

  6. Organizational Structures and Operational Practices of Selected Educational R & D Centers and Educational Laboratories and of Selected Centers, Laboratories, and Institutes on One University Campus.

    ERIC Educational Resources Information Center

    Lins, L. Joseph

    This study investigates and analyzes the organizational structures, institutional ties, and operational practices of selected extramurally-supported centers, laboratories, and institutes. The primary goal is to provide one type of data, some experiences, and judgments on the basis of which an assessment might be made of the conditions of the…

  7. Good Relations between Foster Parents and Birth Parents: A Swedish Study of Practices Promoting Successful Cooperation in Everyday Life

    ERIC Educational Resources Information Center

    Hedin, Lena

    2015-01-01

    The importance for foster children's well-being of good relations between foster parents and birth parents is a common topic of research. This article aims to contribute to an understanding of how co-parenting by foster parents and birth parents works in everyday life, from both parties' perspectives, whether or not they knew each other…

  8. Audit of clinical-laboratory practices in haematology and blood transfusion at Muhimbili National Hospital in Tanzania.

    PubMed

    Makubi, Abel N; Meda, Collins; Magesa, Alex; Minja, Peter; Mlalasi, Juliana; Salum, Zubeda; Kweka, Rumisha E; Rwehabura, James; Quaresh, Amrana; Magesa, Pius M; Robert, David; Makani, Julie; Kaaya, Ephata

    2012-10-01

    In Tanzania, there is paucity of data for monitoring laboratory medicine including haematology. This therefore calls for audits of practices in haematology and blood transfusion in order to provide appraise practice and devise strategies that would result in improved quality of health care services. This descriptive cross-sectional study which audited laboratory practice in haematology and blood transfusion at Muhimbili National Hospital (MNH) aimed at assessing the pre-analytical stage of laboratory investigations including laboratory request forms and handling specimen processing in the haematology laboratory and assessing the chain from donor selection, blood component processing to administration of blood during transfusion. A national standard checklist was used to audit the laboratory request forms (LRF), phlebotomists' practices on handling and assessing the from donor selection to administration 6f blood during transfusion. Both interview and observations were used. A total of 195 LRF were audited and 100% of had incomplete information such as patients' identification numbers, time sample ordered, reason for request, summary of clinical assessment and differential diagnoses. The labelling of specimens was poorly done by phlebotomists/clinicians in 82% of the specimens. Also 65% (132/202) of the blood samples delivered in the haematology laboratory did not contain the recommended volume of blood. There was no laboratory request form specific for ordering blood and there were no guidelines for indication of blood transfusion in the wards/ clinics. The blood transfusion laboratory section was not participating in external quality assessment and the hospital transfusion committee was not in operation. It is recommended that a referral hospital like MNH should have a transfusion committee to provide an active forum to facilitate communication between those involved with transfusion, monitor, coordinate and audit blood transfusion practices as per national

  9. Practice Paper of the Academy of Nutrition and Dietetics: Selecting Nutrient-Dense Foods for Good Health.

    PubMed

    Hingle, Melanie D; Kandiah, Jayanthi; Maggi, Annette

    2016-09-01

    The 2015 Dietary Guidelines for Americans encourage selection of nutrient-dense foods for health promotion and disease prevention and management. The purpose of this Academy of Nutrition and Dietetics practice paper is to provide an update regarding the science and practice of nutrient-dense food identification and selection. Characterization of tools used to identify nutrient density of foods is provided and recommendations for how registered dietitian nutritionists and nutrition and dietetics technicians, registered, might use available profiling tools to help consumers select nutrient-dense foods is discussed. PMID:27568089

  10. Practice-based Research Networks (PBRNs) Are Promising Laboratories for Conducting Dissemination and Implementation Research

    PubMed Central

    Heintzman, John; Gold, Rachel; Krist, Alexander; Crosson, Jay; Likumahuwa, Sonja; DeVoe, Jennifer E.

    2016-01-01

    Dissemination and implementation science addresses the application of research findings in varied health care settings. Despite the potential benefit of dissemination and implementation work to primary care, ideal laboratories for this science have been elusive. Practice-based research networks (PBRNs) have a long history of conducting research in community clinical settings, demonstrating an approach that could be used to execute multiple research projects over time in broad and varied settings. PBRNs also are uniquely structured and increasingly involved in pragmatic trials, a research design central to dissemination and implementation science. We argue that PBRNs and dissemination and implementation scientists are ideally suited to work together and that the collaboration of these 2 groups will yield great value for the future of primary care and the delivery of evidence-based health care. PMID:25381072

  11. "I Am Trying to Practice Good Teaching": Reconceptualizing ePortfolios for Professional Development in Vocational Higher Education

    ERIC Educational Resources Information Center

    Winberg, Christine; Pallitt, Nicola

    2016-01-01

    Teaching portfolios have become increasingly important to university teachers. Portfolio requirements for the appointment or promotion of academic staff recognize that the assessment of teaching practice requires more depth and detail than a candidate's academic CV generally affords. The focus of this study is the electronic teaching portfolios,…

  12. The Good, the Worthwhile and the Obligatory: Practical Reason and Moral Universalism in R. S. Peters' Conception of Education

    ERIC Educational Resources Information Center

    Martin, Christopher

    2009-01-01

    Peters' account of the moral life and the conception of practical reason that informed it reflects a sophisticated moral universalism. However, attempts to extend a similarly sophisticated universalism into our understanding of education are not as well received. Yet, such a project is of clear contemporary relevance given the pressure put on…

  13. Survey of Clinical Laboratory Practices for 2015 Middle East Respiratory Syndrome Coronavirus Outbreak in the Republic of Korea

    PubMed Central

    Lee, Mi-Kyung; Kim, Sinyoung; Kim, Mi-Na; Kweon, Oh Joo; Lim, Yong Kwan; Ki, Chang-Seok; Kim, Jae-Seok; Seong, Moon-Woo; Sung, Heungsup; Yong, Dongeun; Lee, Hyukmin; Choi, Jong-Rak

    2016-01-01

    Background It is crucial to understand the current status of clinical laboratory practices for the largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infections in the Republic of Korea to be well prepared for future emerging infectious diseases. Methods We conducted a survey of 49 clinical laboratories in medical institutions and referral medical laboratories. A short questionnaire to survey clinical laboratory practices relating to MERS-CoV diagnostic testing was sent by email to the directors and clinical pathologists in charge of the clinical laboratories performing MERS-CoV testing. The survey focused on testing volume, reporting of results, resources, and laboratory safety. Results A total of 40 clinical laboratories responded to the survey. A total of 27,009 MERS-CoV real-time reverse transcription PCR (rRT-PCR) tests were performed. Most of the specimens were sputum (73.5%). The median turnaround time (TAT) was 5.29 hr (first and third quartile, 4.11 and 7.48 hr) in 26 medical institutions. The median TAT of more than a half of the laboratories (57.7%) was less than 6 hr. Many laboratories were able to perform tests throughout the whole week. Laboratory biosafety preparedness included class II biosafety cabinets (100%); separated pre-PCR, PCR, and post-PCR rooms (88.6%); negative pressure pretreatment rooms (48.6%); and negative pressure sputum collection rooms (20.0%). Conclusions Clinical laboratories were able to quickly expand their diagnostic capacity in response to the 2015 MERS-CoV outbreak. Our results show that clinical laboratories play an important role in the maintenance and enhancement of laboratory response in preparation for future emerging infections. PMID:26709263

  14. Practical way to develop 10-color flow cytometry protocols for the clinical laboratory

    NASA Astrophysics Data System (ADS)

    Tárnok, Attila; Bocsi, Jozsef

    2010-02-01

    The latest development of commercial routine flow cytometers (FCM) is that they are equipped with three (blue, red, violet) or more lasers and many PMT detectors. Nowadays routine clinical instruments are capable of detecting 10 or more fluorescence colors simultaneously. Thereby, presenting opportunities for getting detailed information on the single cell level for cytomics and systems biology for improve diagnostics and monitoring of patients. The University Leipzig, Germany) recently started a cluster of excellence to study the molecular background of life style and environment associated diseases, enrolling 25000 individuals (LIFE). To this end the most comprehensive FCM protocol has to be developed for this study. We aimed to optimize fluorochrome and antibody combinations to the characteristics of the instrument for successful 10-color FCM. Systematic review of issues related to sampling, preparation, instrument settings, spillover and compensation matrix, reagent performance, and general principles of panel construction was performed. 10-color FCM enables for increased accuracy in cell subpopulation identification, the ability to obtain detailed information from blood specimens, improved laboratory efficiency, and the means to consistently detect major and rare cell populations. Careful attention to details of instrument and reagent performance allows for the development of panels suitable for screening of samples from healthy and diseased donors. The characteristics of this technique are particularly well suited for the analysis of broad human population cohorts and have the potential to reach the everyday practice in a standardized way for the clinical laboratory.

  15. Collaborative Testing in Practical Laboratories: An Effective Teaching-Learning Method in Histology.

    PubMed

    Guo, Yuping; Li, Enzhong

    2016-01-01

    This article presents an experimental teaching and learning program used in histology with first-year students in the second term in the Faculty of Biology at Huanghuai University, China. Eighty-six students were divided randomly into two groups (n=43 per group). Tests were conducted at the end of each practical laboratory (10 laboratories in total) in which collaborative testing was used in the experimental group and traditional testing in the control group. To assess achievement, a final examination in histology was carried out at the end of the course. To determine students' attitude to the teaching styles, a questionnaire survey was conducted at the end of the term. Results showed that students preferred the collaborative testing format. In the experimental group, students' scores were significantly higher than those of students in the control group in final examinations. These findings indicate that collaborative testing enhances student learning and understanding of the material taught, and suggest that collaborative testing is an effective teaching-learning method in histology. PMID:26560548

  16. Core Courses in Public Health Laboratory Science and Practice: Findings from 2006 and 2011 Surveys

    PubMed Central

    Beck, Angela J.; Boulton, Matthew L.; Kim, Deborah H.; Wichman, Michael D.; Luedtke, Patrick F.

    2013-01-01

    Objectives We identified academic training courses or topics most important to the careers of U.S. public health, environmental, and agricultural laboratory (PHEAL) scientist-managers and directors, and determined what portions of the national PHEAL workforce completed these courses. Methods We conducted electronic national surveys in 2006 and 2011, and analyzed data using numerical ranking, Chi-square tests comparing rates, and Spearman's formula measuring rank correlation. Results In 2006, 40 of 50 PHEAL directors identified 56 course topics as either important, useful, or not needed for someone in their position. These course topics were then ranked to provide a list of 31 core courses. In 2011, 1,659 of approximately 5,555 PHEAL scientific and technical staff, using a subset of 25 core courses, evidenced higher core course completion rates associated with higher-level job classification, advanced academic degree, and age. The 2011 survey showed that 287 PHEAL scientist-managers and directors, on average, completed 37.7% (n=5/13) of leadership/managerial core courses and 51.7% (n=6/12) of scientific core courses. For 1,659 laboratorians in all scientific and technical classifications, core-subject completion rates were higher in local laboratories (42.8%, n=11/25) than in state (36.0%, n=9/25), federal (34.4%, n=9/25), and university (31.2%, n=8/25) laboratories. Conclusions There is a definable range of scientific, leadership, and managerial core courses needed by PHEAL scientist-managers and directors to function effectively in their positions. Potential PHEAL scientist-managers and directors need greater and continuing access to these courses, and academic and practice entities supporting development of this workforce should adopt curricula and core competencies aligned with these course topics. PMID:23997310

  17. 21 CFR 606.140 - Laboratory controls.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of...

  18. 21 CFR 606.140 - Laboratory controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of...

  19. 21 CFR 606.140 - Laboratory controls.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of...

  20. 21 CFR 606.140 - Laboratory controls.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of...

  1. 21 CFR 606.140 - Laboratory controls.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Laboratory controls. 606.140 Section 606.140 Food... CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Laboratory Controls § 606.140 Laboratory controls. Laboratory control procedures shall include: (a) The establishment of...

  2. Prepare, Do, Review: A skills-based approach for laboratory practical classes in biochemistry and molecular biology.

    PubMed

    Arthur, Peter; Ludwig, Martha; Castelli, Joane; Kirkwood, Paul; Attwood, Paul

    2016-05-01

    A new laboratory practical system is described which is comprised of a number of laboratory practical modules, each based around a particular technique or set of techniques, related to the theory part of the course but not designed to be dependent on it. Each module comprises an online recorded pre-lab lecture, the laboratory practical itself and a post-lab session in which students make oral presentations on different aspects of the practical. Each part of the module is assessed with the aim of providing rapid feedback to staff and students. Each laboratory practical is the responsibility of a single staff member and through this "ownership," continual review and updating is promoted. Examples of changes made by staff to modules as a result of student feedback are detailed. A survey of students who had experienced both the old-style laboratory course and the new one provided evidence of increased satisfaction with the new program. The assessment of acquired shills in the new program showed that it was much more effective than the old course. © 2016 by The International Union of Biochemistry and Molecular Biology, 44:276-287, 2016. PMID:27161811

  3. What Confucius practiced is good for your mind: Examining the effect of a contemplative practice in Confucian tradition on executive functions.

    PubMed

    Teng, Shan-Chuan; Lien, Yunn-Wen

    2016-05-01

    The short-term training effects on various executive functions (EFs) by a movement-based contemplative practice (MBCP) are examined. Three aspects of EFs (working memory capacity, inhibition, switching) are assessed before and after a month-long 12-h training period using Body-Mind Axial Awareness (BMAA) principles that Confucius followers have practiced for more than 2000years. A mindfulness-based practice (Chan-meditation) and a waiting-list control group served as contrast groups. Our results showed that the BMAA group performed better on the task that measured working memory capacity than did the Chan-meditation and the waiting-list groups after training. In addition, the Chan-meditation groups outperformed the control group on attentional switching, a novel finding for this kind of practice. Our findings not only show a new effect of short-term MBCPs on EFs, but also indicate movement-based and mindfulness-based contemplative practices might benefit development of various aspects of EFs in different ways. PMID:27038245

  4. Cost-effective facility disposition planning with safety and health lessons learned and good practices from the Oak Ridge Decontamination and Decommissioning Program

    SciTech Connect

    1998-05-01

    An emphasis on transition and safe disposition of DOE excess facilities has brought about significant challenges to managing worker, public, and environmental risks. The transition and disposition activities involve a diverse range of hazardous facilities that are old, poorly maintained, and contain radioactive and hazardous substances, the extent of which may be unknown. In addition, many excess facilities do not have historical facility documents such as operating records, plant and instrumentation diagrams, and incident records. The purpose of this report is to present an overview of the Oak Ridge Decontamination and Decommissioning (D and D) Program, its safety performance, and associated safety and health lessons learned and good practices. Illustrative examples of these lessons learned and good practices are also provided. The primary focus of this report is on the safety and health activities and implications associated with the planning phase of Oak Ridge facility disposition projects. Section 1.0 of this report provides the background and purpose of the report. Section 2.0 presents an overview of the facility disposition activities from which the lessons learned and good practices discussed in Section 3.0 were derived.

  5. Effectiveness of Barcoding for Reducing Patient Specimen and Laboratory Testing Identification Errors: A Laboratory Medicine Best Practices Systematic Review and Meta-Analysis

    PubMed Central

    Snyder, Susan R.; Favoretto, Alessandra M.; Derzon, James H.; Christenson, Robert; Kahn, Stephen; Shaw, Colleen; Baetz, Rich Ann; Mass, Diana; Fantz, Corrine; Raab, Stephen; Tanasijevic, Milenko; Liebow, Edward B.

    2015-01-01

    Objectives This is the first systematic review of the effectiveness of barcoding practices for reducing patient specimen and laboratory testing identification errors. Design and Methods The CDC-funded Laboratory Medicine Best Practices Initiative systematic review methods for quality improvement practices were used. Results A total of 17 observational studies reporting on barcoding systems are included in the body of evidence; 10 for patient specimens and 7 for point-of-care testing. All 17 studies favored barcoding, with meta-analysis mean odds ratios for barcoding systems of 4.39 (95% CI: 3.05 – 6.32) and for point-of-care testing of 5.93 (95% CI: 5.28 – 6.67). Conclusions Barcoding is effective for reducing patient specimen and laboratory testing identification errors in diverse hospital settings and is recommended as an evidence-based “best practice.” The overall strength of evidence rating is high and the effect size rating is substantial. Unpublished studies made an important contribution comprising almost half of the body of evidence. PMID:22750145

  6. Student and instructor perceptions of the use of inquiry practices in a Biology Survey Laboratory course

    NASA Astrophysics Data System (ADS)

    Fayer, Lisbeth Ann

    The level of inquiry in science education has been the subject of a great deal of research by organizations such as The National Resource Council, The National Science Teachers Association, and The National Science Resources Center. Although inquiry has been promulgated as best practice, most colleges have not included inquiry science instruction in their coursework. The purpose of this study was to determine the perceptions of the level of inquiry, which students and instructors in a Biology Survey Laboratory I course consider the most supportive of student learning at a small, rural, Midwestern university. A survey instrument developed using the Inquiry Level Rubric designed by Buck et al., (2008) and the Likert Scale (1932) was used to collect data from 192 Biology Survey Laboratory I course students and their two instructors. The instrument consisted of 36 five-point Likert scale items followed by four demographic questions. A total of 190 (99.0%) students' surveys contained usable information for statistical analyses. Semi-structured instructor interviews were completed after the survey. Descriptive statistics including means and standard deviations were analyzed to determine the perceptions of students and their instructors regarding the best level of inquiry to learn biology. Inferential statistical analysis with independent t tests were utilized to determine if there were statistically significant differences between education majors and non-education majors, underrepresented groups and students typically represented in the science fields, and students with high versus low inquiry experience K--12. Qualitative phenomenological data were collected and analyzed from instructor interviews. Descriptive analyses revealed that students perceived that they would learn best with Open or Authentic inquiry levels, while instructors' perceptions leaned towards Open or Guided inquiry levels in the Biology Survey Laboratory I course (Buck et al., 2008). Inferential data

  7. Conceptualizing a model: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-2.

    PubMed

    Roberts, Mark; Russell, Louise B; Paltiel, A David; Chambers, Michael; McEwan, Phil; Krahn, Murray

    2012-01-01

    The appropriate development of a model begins with understanding the problem that is being represented. The aim of this article is to provide a series of consensus-based best practices regarding the process of model conceptualization. For the purpose of this series of papers, the authors consider the development of models whose purpose is to inform medical decisions and health-related resource allocation questions. They specifically divide the conceptualization process into two distinct components: the conceptualization of the problem, which converts knowledge of the health care process or decision into a representation of the problem, followed by the conceptualization of the model itself, which matches the attributes and characteristics of a particular modeling type to the needs of the problem being represented. Recommendations are made regarding the structure of the modeling team, agreement on the statement of the problem, the structure, perspective and target population of the model, and the interventions and outcomes represented. Best practices relating to the specific characteristics of model structure, and which characteristics of the problem might be most easily represented in a specific modeling method, are presented. Each section contains a number of recommendations that were iterated among the authors, as well as the wider modeling taskforce, jointly set up by the International Society for Pharmacoeconomics and Outcomes Research and the Society for Medical Decision Making. PMID:22990083

  8. Conceptualizing a model: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--2.

    PubMed

    Roberts, Mark; Russell, Louise B; Paltiel, A David; Chambers, Michael; McEwan, Phil; Krahn, Murray

    2012-01-01

    The appropriate development of a model begins with understanding the problem that is being represented. The aim of this article was to provide a series of consensus-based best practices regarding the process of model conceptualization. For the purpose of this series of articles, we consider the development of models whose purpose is to inform medical decisions and health-related resource allocation questions. We specifically divide the conceptualization process into two distinct components: the conceptualization of the problem, which converts knowledge of the health care process or decision into a representation of the problem, followed by the conceptualization of the model itself, which matches the attributes and characteristics of a particular modeling type with the needs of the problem being represented. Recommendations are made regarding the structure of the modeling team, agreement on the statement of the problem, the structure, perspective, and target population of the model, and the interventions and outcomes represented. Best practices relating to the specific characteristics of model structure and which characteristics of the problem might be most easily represented in a specific modeling method are presented. Each section contains a number of recommendations that were iterated among the authors, as well as among the wider modeling taskforce, jointly set up by the International Society for Pharmacoeconomics and Outcomes Research and the Society for Medical Decision Making. PMID:22999129

  9. State-transition modeling: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--3.

    PubMed

    Siebert, Uwe; Alagoz, Oguzhan; Bayoumi, Ahmed M; Jahn, Beate; Owens, Douglas K; Cohen, David J; Kuntz, Karen M

    2012-01-01

    State-transition modeling is an intuitive, flexible, and transparent approach of computer-based decision-analytic modeling including both Markov model cohort simulation and individual-based (first-order Monte Carlo) microsimulation. Conceptualizing a decision problem in terms of a set of (health) states and transitions among these states, state-transition modeling is one of the most widespread modeling techniques in clinical decision analysis, health technology assessment, and health-economic evaluation. State-transition models have been used in many different populations and diseases, and their applications range from personalized health care strategies to public health programs. Most frequently, state-transition models are used in the evaluation of risk factor interventions, screening, diagnostic procedures, treatment strategies, and disease management programs. The goal of this article was to provide consensus-based guidelines for the application of state-transition models in the context of health care. We structured the best practice recommendations in the following sections: choice of model type (cohort vs. individual-level model), model structure, model parameters, analysis, reporting, and communication. In each of these sections, we give a brief description, address the issues that are of particular relevance to the application of state-transition models, give specific examples from the literature, and provide best practice recommendations for state-transition modeling. These recommendations are directed both to modelers and to users of modeling results such as clinicians, clinical guideline developers, manufacturers, or policymakers. PMID:22999130

  10. Implementing Best Practices for Data Quality Assessment of the National Renewable Energy Laboratory?s Solar Resource and Meteorological Assessment Project: Preprint

    SciTech Connect

    Wilcox, S. M.; McCormack, P.

    2011-04-01

    Effective solar radiation measurements for research and economic analyses require a strict protocol for maintenance, calibration, and documentation to minimize station downtime and data corruption. The National Renewable Energy Laboratory's Concentrating Solar Power: Best Practices Handbook for the Collection and Use of Solar Resource Data includes guidelines for operating a solar measurement station. This paper describes a suite of automated and semi-automated routines based on the best practices handbook as developed for the National Renewable Energy Laboratory Solar Resource and Meteorological Assessment Project. These routines allow efficient inspection and data flagging to alert operators of conditions that require immediate attention. Although the handbook is targeted for concentrating solar power applications, the quality-assessment procedures described are generic and should benefit many solar measurement applications. The routines use data in one-minute measurement resolution, as suggested by the handbook, but they could be modified for other time scales.

  11. Defining the role of University of Kentucky HealthCare in its medical market--how strategic planning creates the intersection of good public policy and good business practices.

    PubMed

    Karpf, Michael; Lofgren, Richard; Bricker, Timothy; Claypool, Joseph O; Zembrodt, Jim; Perman, Jay; Higdon, Courtney M

    2009-02-01

    In response both to national pressures to reduce costs and improve health care access and outcomes and to local pressures to become a top-20 public research university, the University of Kentucky moved toward an integrated clinical enterprise, UK HealthCare, to create a common vision, shared goals, and an effective decision-making process. The leadership formed the vision and then embarked on a comprehensive and coordinated planning process that addressed financial, clinical, academic, and operational issues. The authors describe in depth the strategic planning process and specifically the definition of UK HealthCare's role in its medical marketplace. They began a rigorous process to assess and develop goals for the clinical programs and followed the progress of these programs through meetings driven by data and attended by the organization's senior leadership. They describe their approach to working with rural and community hospitals throughout central, eastern, and southern Kentucky to support the health care infrastructure of the state. They review the early successes of their strategic approach and describe the lessons they learned. The clinical successes have led to academic gains. The experience of UK HealthCare suggests that good business practices and good public policy are synergistic. PMID:19174658

  12. Protein Biomarker Research in UK Hospital Clinical Biochemistry Laboratories: A Survey of Current Practice and Views

    PubMed Central

    Hepburn, Sophie; Banks, Rosamonde E; Thompson, Douglas

    2014-01-01

    Background: With the increasing drive for more and better disease biomarkers to underpin the stratified or personalised medicine agenda, clinical biochemistry laboratories should be ideally placed to play a major role in their translation into clinical practice. However, little is known about the current extent of biomarker-related research activity in UK National Health Service clinical biochemistry departments. Methods: In December 2010, an online questionnaire was sent to active UK members of the Association for Clinical Biochemistry (ACB) to determine the extent of their current research activity and involvement in protein biomarker discovery and translation, including an assessment of the awareness of proteomics. Results: A total of 198 eligible responses (19% response rate) was received from across the UK. Of a further 50 eligible people who responded to a follow-up for initial non-responders, most cited insufficient knowledge about the topic as the reason for non-response (24% total response rate). The results illustrate the highly skilled nature of the workforce with many having experience in a research environment (75%) with postgraduate qualifications. However, more than half spend <10% of their time undertaking research in their current role, and many (61%) would like to be more research active. Encouragingly, approximately a third were involved in biomarker discovery activities, even though for <10% of their time, with slightly more reporting involvement in biomarker translation. Conclusions: Although there are people with the necessary skills and desire to be involved in biomarker research in clinical biochemistry departments, their involvement is small, predominantly due to issues with capacity and resources. It is likely that the majority of biomarker programmes will therefore continue to be carried out by a small number of academic groups, hopefully with collaborative input from hospital laboratories. PMID:25210209

  13. 'God grant it may do good two all': the madhouse practice of Joseph Mason, 1738-79.

    PubMed

    Smith, Leonard

    2016-06-01

    Private madhouses made a significant contribution to the development of psychiatric practices in eighteenth-century England. Joseph Mason of Bristol, proprietor of a madhouse at Stapleton and then at nearby Fishponds, was part of a dynasty of successful and respected mad-doctors. A deeply religious man, his Christian ethics constituted the guiding force in his work with patients and interactions with their relatives. He was also an astute man of business, who recognized that comfortable domestic surroundings and the achievement of recoveries would enhance his reputation and attract lucrative middle-class custom. His treatment approaches, illustrated in a 1763 diary, were eclectic and pragmatic, comprising various medicines, dietary regulation, graded social interactions, and the cultivation of individualized therapeutic relationships with his patients. PMID:26837815

  14. [Needs, uses, cons-pros, good practices and opportunities about walker in elderly with loss of autonomy].

    PubMed

    Mézière, Anthony; Schonheit, Claire; Moreau, Caroline; Baudry, Elodie; Monié, Marguerite; Piette, François; Curtis, Valentine; Pasqui, Viviane

    2015-01-01

    Non-use of the walker may be secondary to an initial inappropriate prescribing, a lack of adequate training, a lack of monitoring and side effects of using. Improving both stability and mobility in users is due to several biomechanical mechanisms. The benefits of walker are: general physiological effects, more confidence, better social life and decrease in the burden of care. The disadvantages of walker are: technical or practical aspects criticized by users, musculoskeletal disorders, delayed reaction time, fall risk and stigma. Few scientific data evaluating the interest of the walker concerning mobility exist, thus recommendations are low grade and are often taken from professional clinical experiences. The choice of technical walking assistance depends on the pathology and biomechanical mechanism. The walker robots are few distributed. PMID:25964157

  15. Health care for immigrants in Europe: Is there still consensus among country experts about principles of good practice? A Delphi study

    PubMed Central

    2011-01-01

    Background European Member States are facing a challenge to provide accessible and effective health care services for immigrants. It remains unclear how best to achieve this and what characterises good practice in increasingly multicultural societies across Europe. This study assessed the views and values of professionals working in different health care contexts and in different European countries as to what constitutes good practice in health care for immigrants. Methods A total of 134 experts in 16 EU Member States participated in a three-round Delphi process. The experts represented four different fields: academia, Non-Governmental Organisations, policy-making and health care practice. For each country, the process aimed to produce a national consensus list of the most important factors characterising good practice in health care for migrants. Results The scoring procedures resulted in 10 to 16 factors being identified as the most important for each participating country. All 186 factors were aggregated into 9 themes: (1) easy and equal access to health care, (2) empowerment of migrants, (3) culturally sensitive health care services, (4) quality of care, (5) patient/health care provider communication, (6) respect towards migrants, (7) networking in and outside health services, (8) targeted outreach activities, and (9) availability of data about specificities in migrant health care and prevention. Although local political debate, level of immigration and the nature of local health care systems influenced the selection and rating of factors within each country, there was a broad European consensus on most factors. Yet, discordance remained both within countries, e.g. on the need for prioritising cultural differences, and between countries, e.g. on the need for more consistent governance of health care services for immigrants. Conclusions Experts across Europe asserted the right to culturally sensitive health care for all immigrants. There is a broad consensus

  16. [The institutional promotion of good practices in the operational management of health and safety: the experience of Italy Crown Aerosols on the monitoring of behavior].

    PubMed

    de Merich, D; Pellicci, M; Serignoli, R

    2010-01-01

    Within the intelligence support and training to small and medium-sized enterprises (SMEs) and promoting a culture of health and safety at work, ISPESL is engaged on two fundamental pillars of activity: Consolidation of the national surveillance system of injuries through the promotion of methods and tools for the reconstruction of the dynamics incidental identification of causal determinants, with the aim of improving the capabilities of risk assessment of systems to prevent corporate. The promotion of good working practices, as Focal Point of the European Health and Safety at Work in Bilbao, the goal is to support prevention activities by providing business application examples of measures for improvement (technical, organizational, procedural) made in the proposing firms and validated by a technical appraisal conducted by ISPESL. Among the methodologies and tools that can be made available to companies in the operational management of health and safety in work activities, the approach to analyze and evaluate the behavior implemented by all persons within the company (managers, employees, workers) is a the most innovative preventive strategies that can be implemented to correct any improper practices behavioral wrongly tolerated in everyday work practice. The experience of Crown Aerosol Italy, the program "STOP TO ACCIDENTS, 2009 Best Practices award in the competition on the theme" Risk Assessment ", aims to demonstrate how the application of a method for monitoring behavior at work, shared in its planning with all those business, has not only reached but would assist the organization has developed at an individual level greater awareness and sense of responsibility also to their colleagues, by promoting good working practices. PMID:20518217

  17. 21 CFR 58.49 - Laboratory operation areas.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Laboratory operation areas. 58.49 Section 58.49 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Facilities § 58.49 Laboratory operation areas. Separate laboratory space shall be provided,...

  18. 21 CFR 58.49 - Laboratory operation areas.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Laboratory operation areas. 58.49 Section 58.49 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Facilities § 58.49 Laboratory operation areas. Separate laboratory space shall be provided,...

  19. Three Myths About Dietary Supplements … and How Knowing the Right Answers Is Good for Your Integrative Medicine Practice.

    PubMed

    Israelsen, Loren; Lampe, Frank

    2016-06-01

    The use of safe and beneficial dietary supplements remains an important part of your patients' healthy lifestyle-and supplements are likely an important part of your integrative medicine practice. Although issues surrounding potency, ingredient identification, adulteration, and the enforcement of existing laws are legitimate concerns for medical professionals and consumers, the responsible industry is actively working to raise quality standards for its products through a number of self-regulatory measures. These include education about and adoption of additional quality assurance initiatives, such as GMPs for botanical ingredients; better supply-chain management; adoption of improved identification and testing methodologies; an industry-wide product registry; the use of accredited third-party certifications and seals; and initiatives to promote widespread membership in the industry's trade associations, which is a reliable indicator of a company's support of and adherence to strict quality guidelines. Also, industry support of appropriate enforcement actions against problem players and products from the US Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and states' attorneys general continues in an effort to rid the market of unsafe and mislabeled products. PMID:27547162

  20. A practical review on photooxidation of crude oil: laboratory lamp setup and factors affecting it.

    PubMed

    Shankar, Ravi; Shim, Won Joon; An, Joon Geon; Yim, Un Hyuk

    2015-01-01

    After an oil spill, crude oil in the marine environment is affected by a variety of processes collectively called weathering. Photooxidation induced by ultraviolet (UV) light from the sun is one of the most significant processes of long-term weathering that changes the chemical nature of oil. Experimental studies on photooxidation in the natural environment are generally not practicable due to the variability of factors that are more readily controlled in a laboratory. The emission spectra and irradiance of artificial lamps are critical factors for simulating sunlight, and the process of acceleration should be differentiated from simulation. We present a comprehensive review of the exposure conditions affecting in vitro photooxidation studies, including the types of lamps, their spectra and irradiance levels and maintenance conditions. The importance of xenon arc, metal halide along with mercury–xenon, high-pressure mercury lamps and other lamps with respect to their spectral characteristics is discussed and the selection guide is provided. A brief discussion on other factors affecting photooxidation rates and outcomes, such as photosensitisers, photodegraders, solvents and the synergistic effects of compounds is also given. PMID:25462738

  1. Is my model good enough? Best practices for verification and validation of musculoskeletal models and simulations of movement.

    PubMed

    Hicks, Jennifer L; Uchida, Thomas K; Seth, Ajay; Rajagopal, Apoorva; Delp, Scott L

    2015-02-01

    Computational modeling and simulation of neuromusculoskeletal (NMS) systems enables researchers and clinicians to study the complex dynamics underlying human and animal movement. NMS models use equations derived from physical laws and biology to help solve challenging real-world problems, from designing prosthetics that maximize running speed to developing exoskeletal devices that enable walking after a stroke. NMS modeling and simulation has proliferated in the biomechanics research community over the past 25 years, but the lack of verification and validation standards remains a major barrier to wider adoption and impact. The goal of this paper is to establish practical guidelines for verification and validation of NMS models and simulations that researchers, clinicians, reviewers, and others can adopt to evaluate the accuracy and credibility of modeling studies. In particular, we review a general process for verification and validation applied to NMS models and simulations, including careful formulation of a research question and methods, traditional verification and validation steps, and documentation and sharing of results for use and testing by other researchers. Modeling the NMS system and simulating its motion involves methods to represent neural control, musculoskeletal geometry, muscle-tendon dynamics, contact forces, and multibody dynamics. For each of these components, we review modeling choices and software verification guidelines; discuss variability, errors, uncertainty, and sensitivity relationships; and provide recommendations for verification and validation by comparing experimental data and testing robustness. We present a series of case studies to illustrate key principles. In closing, we discuss challenges the community must overcome to ensure that modeling and simulation are successfully used to solve the broad spectrum of problems that limit human mobility. PMID:25474098

  2. “You Have No Good Blood in Your Body”. Oral Communication in Sixteenth-Century Physicians’ Medical Practice

    PubMed Central

    Stolberg, Michael

    2015-01-01

    In his personal notebooks, the little known Bohemian physician Georg Handsch (1529–c. 1578) recorded, among other things, hundreds of vernacular phrases and expressions he and other physicians used in their oral interaction with patients and families. Based primarily on this extraordinary source, this paper traces the terms, concepts and images to which sixteenth-century physicians resorted when they explained the nature of a patient’s disease and justified their treatment. At the bedside and in the consultation room, Handsch and his fellow physicians attributed most diseases to a local accumulation of impure, putrid or otherwise pathological humours. The latter were commonly said to result, in turn, from an insufficient concoction and assimilation of food and drink in the stomach and the liver or from an obstruction of the humoral flow inside the body and across its borders. By contrast, other notions and explanatory models, which had a prominent place in contemporary learned medical writing, hardly played a role at all in the physicians’ oral communication. Specific disease terms were rarely used, a mere imbalance of the four natural humours in the body was almost never inculpated, and the patient’s personal life-style and other non-naturals did not attract much attention either. These striking differences between the ways in which physicians explained the patients’ diseases in their daily practice and the explanatory models we find in contemporary textbooks, are attributed, above all, to the physicians’ precarious situation in the early modern medical marketplace. Since dissatisfied patients were quick to turn to another healer, physicians had to explain the disease and justify their treatment in a manner that was comprehensible to ordinary lay people and in line with their expectations and beliefs, which, at the time, revolved almost entirely around notions of impurity and evacuation. PMID:25498438

  3. "You have no good blood in your body". Oral communication in sixteenth-century physicians' medical practice.

    PubMed

    Stolberg, Michael

    2015-01-01

    In his personal notebooks, the little known Bohemian physician Georg Handsch (1529-c. 1578) recorded, among other things, hundreds of vernacular phrases and expressions he and other physicians used in their oral interaction with patients and families. Based primarily on this extraordinary source, this paper traces the terms, concepts and images to which sixteenth-century physicians resorted when they explained the nature of a patient's disease and justified their treatment. At the bedside and in the consultation room, Handsch and his fellow physicians attributed most diseases to a local accumulation of impure, putrid or otherwise pathological humours. The latter were commonly said to result, in turn, from an insufficient concoction and assimilation of food and drink in the stomach and the liver or from an obstruction of the humoral flow inside the body and across its borders. By contrast, other notions and explanatory models, which had a prominent place in contemporary learned medical writing, hardly played a role at all in the physicians' oral communication. Specific disease terms were rarely used, a mere imbalance of the four natural humours in the body was almost never inculpated, and the patient's personal life-style and other non-naturals did not attract much attention either. These striking differences between the ways in which physicians explained the patients' diseases in their daily practice and the explanatory models we find in contemporary textbooks, are attributed, above all, to the physicians' precarious situation in the early modern medical marketplace. Since dissatisfied patients were quick to turn to another healer, physicians had to explain the disease and justify their treatment in a manner that was comprehensible to ordinary lay people and in line with their expectations and beliefs, which, at the time, revolved almost entirely around notions of impurity and evacuation. PMID:25498438

  4. Cerebrospinal fluid protein and glucose examinations and tuberculosis:
Will laboratory safety regulations force a change of practice?

    PubMed Central

    Tormey, William P.; O’Hagan, Christopher

    2015-01-01

    Cerebrospinal fluid (CSF) protein and glucose examinations are usually performed in chemical pathology departments on autoanalysers. Tuberculosis (TB) is a group 3 biological agent under Directive 2000/54/EC of the European Parliament but in the biochemistry laboratory, no extra precautions are taken in its analysis in possible TB cases. The issue of laboratory practice and safety in the biochemical analyses of CSF specimens, when tuberculosis infection is in question is addressed in the context of ambiguity in the implementation of current national and international health and safety regulations. Additional protective measures for laboratory staff during the analysis of CSF TB samples should force a change in current laboratory practice and become a regulatory issue under ISO 15189. Annual Mantoux skin test or an interferon-γ release assay for TB should be mandatory for relevant staff. This manuscript addresses the issue of biochemistry laboratory practice and safety in the biochemical analyses of CSF specimens when tuberculosis infection is in question in the context of the ambiguity of statutory health and safety regulations. PMID:26526598

  5. Comparison of a Computer Simulation Program and a Traditional Laboratory Practical Class for Teaching the Principles of Intestinal Absorption.

    ERIC Educational Resources Information Center

    Dewhurst, D. G.; And Others

    1994-01-01

    Evaluates the effectiveness of an interactive computer-assisted learning program for undergraduate students that simulates experiments performed using isolated, everted sacs of rat small intestine. The program is designed to offer an alternative student-centered approach to traditional laboratory-based practical classes. Knowledge gain of students…

  6. Discourse Patterns at Laboratory Practices and the Co-Construction of Knowledge by Applying SDIS-GSEQ

    ERIC Educational Resources Information Center

    Carrillo, Edgardo Ruiz; González, José Luis Cruz; Martínez, Samuel Meraz; Sánchez, Luisa Bravo

    2015-01-01

    The purpose of this study is to analyze the discourse through IRE (Intervention-Response-Evaluation) in the co-construction of knowledge of Biology students during laboratory practices by applying the SDIS-GSEQ software to assess IRE discourse patterns developed during the same. The study group consisted of second semester students of the…

  7. Clinical Practice as Natural Laboratory for Psychotherapy Research: A Guide to Case-Based Time-Series Analysis

    ERIC Educational Resources Information Center

    Borckardt, Jeffrey J.; Nash, Michael R.; Murphy, Martin D.; Moore, Mark; Shaw, Darlene; O'Neil, Patrick

    2008-01-01

    Both researchers and practitioners need to know more about how laboratory treatment protocols translate to real-world practice settings and how clinical innovations can be systematically tested and communicated to a skeptical scientific community. The single-case time-series study is well suited to opening a productive discourse between practice…

  8. Solar Tyrol project: using climate data for energy production estimation. The good practice of Tyrol in conceptualizing climate services.

    NASA Astrophysics Data System (ADS)

    Petitta, Marcello; Wagner, Jochen; Costa, Armin; Monsorno, Roberto; Innerebner, Markus; Moser, David; Zebisch, Marc

    2014-05-01

    The scientific community in the last years is largely discussing the concept of "Climate services". Several definitions have been used, but it still remains a rather open concept. We used climate data from analysis and reanalysis to create a daily and hourly model of atmospheric turbidity in order to account the effect of the atmosphere on incoming solar radiation with the final aim of estimating electric production from Photovoltaic (PV) Modules in the Alps. Renewable Energy production in the Alpine Region is dominated by hydroelectricity, but the potential for photovoltaic energy production is gaining momentum. Especially the southern part of the Alps and inner Alpine regions offer good conditions for PV energy production. The combination of high irradiance values and cold air temperature in mountainous regions is well suited for solar cells. To enable more widespread currency of PV plants, PV has to become an important part in regional planning. To provide regional authorities and also private stakeholders with high quality PV energy yield climatology in the provinces of Bolzano/Bozen South Tirol (Italy) and Tyrol (Austria), the research project Solar Tyrol was inaugurated in 2012. Several methods are used to calculate very high resolution maps of solar radiation. Most of these approaches use climatological values. In this project we reconstructed the last 10 years of atmospheric turbidity using reanalysis and operational data in order to better estimate incoming solar radiation in the alpine region. Our method is divided into three steps: i) clear sky radiation: to estimate the atmospheric effect on solar radiation we calculated Linke Turbidity factor using aerosols optical depth (AOD), surface albedo, atmospheric pressure, and total water content from ECMWF and MACC analysis. ii) shadows: we calculated shadows of mountains and buildings using a 2 meter-resolution digital elevation model of the area and GIS module r.sun modified to fit our specific needs. iii

  9. Good Practice Chaplaincy: An Exploratory Study Identifying the Appropriate Skills, Attitudes and Practices for the Selection, Training and Utilisation of Chaplains.

    PubMed

    Carey, Lindsay B; Rumbold, Bruce

    2015-08-01

    This article presents an overview of exploratory research regarding the skills, knowledge, attitudes and practices considered necessary for chaplains to be highly competent in providing holistic care to clients and staff. Utilising a qualitative methodology, two focus groups comprising Salvation Army chaplains and their managers provided data about their expectations of chaplaincy personnel and about the pastoral care interventions undertaken by chaplains. The results indicated that while there were some differences in opinion, nevertheless, in overall terms, there was general agreement between chaplains and their managers about particular personal and professional qualities necessary for chaplains to be considered appropriate and proficient. Evidence was also obtained indicating a need for change with regard to the organisational attitude and culture of The Salvation Army towards chaplaincy. Recommendations are presented concerning (1) the selection criteria for chaplaincy, (2) training and utilisation of chaplains plus (3) issues relating to organizational cultural change necessary to develop a future-ready chaplaincy more suitable for the twenty-first century. PMID:25371346

  10. Building trust and confidence in laboratory ES and H policy and practices

    SciTech Connect

    Graf, J.

    2000-08-01

    This report describes a successful pilot event among LANL employees that can see as a model for employee involvement and community input. The conference was designed to begin building trust and confidence in Laboratory policy and practices in the area of Environment, Safety, and Health (ES and H). It represents a concrete step toward fostering better relationships among Lab employees and creating a new, innovative approach to communication that can also be used to build trust in the larger community. Based on the proven methods of the National Issues Forums and the Jefferson Center Citizen Jury Process, this conference enabled management to learn more about the thoughts and advice of LANL employees, During the course of the day, a random sample of Lab employees representing the LANL workforce learned about issues of health, safety and the environment, and some of the options available to increase trustworthiness in these areas. These Employee Advisors then discussed the options at some length and presented recommendations to senior Lab managers in the role of Decision Makers. At the end of the day, the participants offered their reflections and discussed what they learned during the conference, and Decision Makers responded to what they heard. The most common view expressed by the Employee Advisors was that a bottom-up approach was necessary to develop more relevant ES and H policies. They were unanimous in their desire for more employee inclusion into the decision making process. All Employee Advisors were in support of a Lab wide survey to determine employee concerns about ES and H issues. After listening to the deliberation, the Decision Makers responded with several commitments. The most significant was the pledge to meet with Employee Advisors by the end of February to discuss the status of their recommendations on ES and H policy and practices. The ensuing follow-up meeting explored employee concerns in greater depth resulting in forward-looking action steps

  11. Influence of good manufacturing practices on the shelf life of refrigerated fillets of tilapia (Oreochromis niloticus) packed in modified atmosphere and gamma-irradiated

    PubMed Central

    Monteiro, Maria Lúcia Guerra; Mársico, Eliane Teixeira; Mano, Sérgio Borges; Teixeira, Claudia Emília; da Cruz Silva Canto, Anna Carolina Vilhena; de Carvalho Vital, Helio; Conte-Júnior, Carlos Adam

    2013-01-01

    This study evaluated the influence of good manufacturing practices (GMP) on the shelf life of refrigerated fillets of Nile tilapia (Oreochromis niloticus) packed in modified atmosphere packaging (MAP) and irradiated. In a first series of experiments, 120 tilapia fillets kept under controlled sanitary conditions were purchased from a fish market managed by a cooperative. A second lot totaling 200 tilapia fillets was obtained under controlled storage conditions from a pilot plant. The combined effects of MAP (40% CO2 and 60% N2) and irradiation (1.5 kGy) were investigated by monitoring physical and chemical (total volatile bases and pH), bacteriological (aerobic heterotrophic mesophilic and psychrophilic bacteria) and sensory (acceptance test) changes in the samples. The quality of samples decreased with storage time regardless of the treatment, remaining higher in fillets produced in the pilot plant in comparison with the commercially produced fillets. The observed shelf life of nonirradiated commercially produced fillets was only 3 days, compared to 8 days for those produced in the pilot plant, probably due to GMP in the latter. It was concluded that, even with a combination of proven conservation methods for meats, the adoption of good manufacturing practices still remains essential before, during, and after the filleting process in order to ensure the effectiveness of the entire treatment. PMID:24804034

  12. Multiple Criteria Decision Analysis for Health Care Decision Making--An Introduction: Report 1 of the ISPOR MCDA Emerging Good Practices Task Force.

    PubMed

    Thokala, Praveen; Devlin, Nancy; Marsh, Kevin; Baltussen, Rob; Boysen, Meindert; Kalo, Zoltan; Longrenn, Thomas; Mussen, Filip; Peacock, Stuart; Watkins, John; Ijzerman, Maarten

    2016-01-01

    Health care decisions are complex and involve confronting trade-offs between multiple, often conflicting, objectives. Using structured, explicit approaches to decisions involving multiple criteria can improve the quality of decision making and a set of techniques, known under the collective heading multiple criteria decision analysis (MCDA), are useful for this purpose. MCDA methods are widely used in other sectors, and recently there has been an increase in health care applications. In 2014, ISPOR established an MCDA Emerging Good Practices Task Force. It was charged with establishing a common definition for MCDA in health care decision making and developing good practice guidelines for conducting MCDA to aid health care decision making. This initial ISPOR MCDA task force report provides an introduction to MCDA - it defines MCDA; provides examples of its use in different kinds of decision making in health care (including benefit risk analysis, health technology assessment, resource allocation, portfolio decision analysis, shared patient clinician decision making and prioritizing patients' access to services); provides an overview of the principal methods of MCDA; and describes the key steps involved. Upon reviewing this report, readers should have a solid overview of MCDA methods and their potential for supporting health care decision making. PMID:26797229

  13. Influence of good manufacturing practices on the shelf life of refrigerated fillets of tilapia (Oreochromis niloticus) packed in modified atmosphere and gamma-irradiated.

    PubMed

    Monteiro, Maria Lúcia Guerra; Mársico, Eliane Teixeira; Mano, Sérgio Borges; Teixeira, Claudia Emília; da Cruz Silva Canto, Anna Carolina Vilhena; de Carvalho Vital, Helio; Conte-Júnior, Carlos Adam

    2013-07-01

    This study evaluated the influence of good manufacturing practices (GMP) on the shelf life of refrigerated fillets of Nile tilapia (Oreochromis niloticus) packed in modified atmosphere packaging (MAP) and irradiated. In a first series of experiments, 120 tilapia fillets kept under controlled sanitary conditions were purchased from a fish market managed by a cooperative. A second lot totaling 200 tilapia fillets was obtained under controlled storage conditions from a pilot plant. The combined effects of MAP (40% CO2 and 60% N2) and irradiation (1.5 kGy) were investigated by monitoring physical and chemical (total volatile bases and pH), bacteriological (aerobic heterotrophic mesophilic and psychrophilic bacteria) and sensory (acceptance test) changes in the samples. The quality of samples decreased with storage time regardless of the treatment, remaining higher in fillets produced in the pilot plant in comparison with the commercially produced fillets. The observed shelf life of nonirradiated commercially produced fillets was only 3 days, compared to 8 days for those produced in the pilot plant, probably due to GMP in the latter. It was concluded that, even with a combination of proven conservation methods for meats, the adoption of good manufacturing practices still remains essential before, during, and after the filleting process in order to ensure the effectiveness of the entire treatment. PMID:24804034

  14. Practical biosafety in the tuberculosis laboratory: containment at the source is what truly counts.

    PubMed

    van Soolingen, D; Wisselink, H J; Lumb, R; Anthony, R; van der Zanden, A; Gilpin, C

    2014-08-01

    In industrialised countries, sufficient resources for establishing and maintaining fully equipped biosafety level 3 (BSL-3) laboratories according to international standards are generally available. BSL-3 laboratories are designed to provide several layers of containment to protect the laboratory worker as well as the outside environment and community from risk of exposure in case of local contamination. However, such facilities are scarce in high-burden settings, primarily due to the high financial burden and complexity of the initial construction and/or regular maintenance. Measures to prevent unintended exposure to Mycobacterium tuberculosis during laboratory manipulation of specimens and cultures is the first, and by far the most important, aspect of containment. This paper focuses on the need for risk containment at source. Assuming that in many settings the establishment of BSL-3 laboratories with all the required features is not achievable, this paper also discusses the minimum requirements necessary to mitigate risks associated with particular laboratory procedures. The term 'TB containment laboratory' is used throughout this paper to describe the minimum requirements for a laboratory suitable for high-risk procedures. The TB containment laboratory has many, but not all, of the features of a BSL-3 laboratory. PMID:25199000

  15. Application of good practices as described by the NEPSI agreement coincides with a strong decline in the exposure to respiratory crystalline silica in Finnish workplaces.

    PubMed

    Tuomi, Tapani; Linnainmaa, Markku; Väänänen, Virpi; Reijula, Kari

    2014-08-01

    To protect the health of those occupationally exposed to respirable crystalline silica, the main industries in European Union associated with exposure to respirable silica, agreed on appropriate measures for the improvement of working conditions through the application of good practices, as part of 'The Agreement on Workers Health Protection through the Good Handling and Use of Crystalline Silica and Products Containing it' (NEPSI agreement), signed in April 2006. The present paper examines trends in exposure to respirable crystalline silica in Finland prior to and following the implementation of the NEPSI agreement and includes a working example of the NEPSI approach in the concrete industry. Data derived from workplace exposure assessments during the years 1994-2013 are presented, including 2556 air samples collected mostly indoors, from either the breathing zone of workers or from stationary points usually at a height of 1.5 m above the floor, with the aim to estimate average exposure of workers to respiratory crystalline silica during an 8-h working day. The aim was, to find out how effective this unique approach has been in the management of one of the major occupational hazards in the concerned industries. Application of good practices as described by the NEPSI agreement coincides with a strong decline in the exposure to respirable crystalline silica in Finnish workplaces, as represented by the clientele of Finnish Institute of Occupational Health. During the years followed in the present study, we see a >10-fold decrease in the average and median exposures to respirable silica. Prior to the implementation of the NEPSI agreement, >50% of the workplace measurements yielded results above the OEL8 h (0.2mg m(-3)). As of present (2013), circa 10% of the measurements are above of or identical to the OEL8 h (0.05mg m(-3)). PMID:24914034

  16. Nomenclature and basic concepts in automation in the clinical laboratory setting: a practical glossary.

    PubMed

    Evangelopoulos, Angelos A; Dalamaga, Maria; Panoutsopoulos, Konstantinos; Dima, Kleanthi

    2013-01-01

    In the early 80s, the word automation was used in the clinical laboratory setting referring only to analyzers. But in late 80s and afterwards, automation found its way into all aspects of the diagnostic process, embracing not only the analytical but also the pre- and post-analytical phase. While laboratories in the eastern world, mainly Japan, paved the way for laboratory automation, US and European laboratories soon realized the benefits and were quick to follow. Clearly, automation and robotics will be a key survival tool in a very competitive and cost-concious healthcare market. What sets automation technology apart from so many other efficiency solutions are the dramatic savings that it brings to the clinical laboratory. Further standardization will assure the success of this revolutionary new technology. One of the main difficulties laboratory managers and personnel must deal with when studying solutions to reengineer a laboratory is familiarizing themselves with the multidisciplinary and technical terminology of this new and exciting field. The present review/glossary aims at giving an overview of the most frequently used terms within the scope of laboratory automation and to put laboratory automation on a sounder linguistic basis. PMID:24409653

  17. Raising the standard: changes to the Australian Code of Good Manufacturing Practice (cGMP) for human blood and blood components, human tissues and human cellular therapy products.

    PubMed

    Wright, Craig; Velickovic, Zlatibor; Brown, Ross; Larsen, Stephen; Macpherson, Janet L; Gibson, John; Rasko, John E J

    2014-04-01

    In Australia, manufacture of blood, tissues and biologicals must comply with the federal laws and meet the requirements of the Therapeutic Goods Administration (TGA) Manufacturing Principles as outlined in the current Code of Good Manufacturing Practice (cGMP). The Therapeutic Goods Order (TGO) No. 88 was announced concurrently with the new cGMP, as a new standard for therapeutic goods. This order constitutes a minimum standard for human blood, tissues and cellular therapeutic goods aimed at minimising the risk of infectious disease transmission. The order sets out specific requirements relating to donor selection, donor testing and minimisation of infectious disease transmission from collection and manufacture of these products. The Therapeutic Goods Manufacturing Principles Determination No. 1 of 2013 references the human blood and blood components, human tissues and human cellular therapy products 2013 (2013 cGMP). The name change for the 2013 cGMP has allowed a broadening of the scope of products to include human cellular therapy products. It is difficult to directly compare versions of the code as deletion of some clauses has not changed the requirements to be met, as they are found elsewhere amongst the various guidelines provided. Many sections that were specific for blood and blood components are now less prescriptive and apply to a wider range of cellular therapies, but the general overall intent remains the same. Use of 'should' throughout the document instead of 'must' allows flexibility for alternative processes, but these systems will still require justification by relevant logical argument and validation data to be acceptable to TGA. The cGMP has seemingly evolved so that specific issues identified at audit over the last decade have now been formalised in the new version. There is a notable risk management approach applied to most areas that refer to process justification and decision making. These requirements commenced on 31 May 2013 and a 12 month

  18. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and...

  19. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and...

  20. 21 CFR 226.58 - Laboratory controls.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and...