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... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...

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 10...

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 10...

40 CFR 62.15145 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2010 CFR

2010-07-01

... requirements for my municipal waste combustion unit? 62.15145 Section 62.15145 Protection of Environment... Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operating Requirements § 62.15145 What are the operating practice requirements for my municipal waste combustion unit? (a) You...

40 CFR 62.15145 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2011 CFR

2011-07-01

... requirements for my municipal waste combustion unit? 62.15145 Section 62.15145 Protection of Environment... Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operating Requirements § 62.15145 What are the operating practice requirements for my municipal waste combustion unit? (a) You...

40 CFR 62.15145 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2014 CFR

2014-07-01

... requirements for my municipal waste combustion unit? 62.15145 Section 62.15145 Protection of Environment... Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operating Requirements § 62.15145 What are the operating practice requirements for my municipal waste combustion unit? (a) You...

40 CFR 62.15145 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2012 CFR

2012-07-01

... requirements for my municipal waste combustion unit? 62.15145 Section 62.15145 Protection of Environment... Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operating Requirements § 62.15145 What are the operating practice requirements for my municipal waste combustion unit? (a) You...

40 CFR 62.15145 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2013 CFR

2013-07-01

... requirements for my municipal waste combustion unit? 62.15145 Section 62.15145 Protection of Environment... Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operating Requirements § 62.15145 What are the operating practice requirements for my municipal waste combustion unit? (a) You...

Alternative Fuels Data Center

Science.gov Websites

technologies and operational practices which increase fuel efficiency and reduce emissions from goods movement . EPA provides partners with performance benchmarking tools, fleet management best practices, technology is working with partners to test and verify advanced technologies and operational practices that save

76 FR 718 - General Administrative Regulations; Good-Performance Refunds

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-06

... demonstrate good farming practices, providing, in effect, a premium discount to individual producers... Refund program will specifically encourage sound management practices as well as encouraging insured... regardless of the size of their farming operation. The amount of work required of the insurance companies...

21 CFR 129.1 - Current good manufacturing practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

... drinking water are in conformance with or are operated or administered in conformity with good manufacturing practice to assure that bottled drinking water is safe and that it has been processed, bottled...) FOOD FOR HUMAN CONSUMPTION PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER General Provisions § 129.1...

76 FR 28045 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-13

...] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for... Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements'' has been...

The confusion in complying with good manufacturing practice requirements in Malaysia

NASA Astrophysics Data System (ADS)

Jali, Mohd Bakri; Ghani, Maaruf Abdul; Nor, Norazmir Md

2016-11-01

Food manufacturing operations need to fulfil regulatory requirements related to hygiene and good manufacturing practices (GMP) to successfully market their products as safe and quality products. GMP based on its ten elements used as guidelines to ensure control over biological, chemical and physical hazards. This study aims to investigate the confusion for design and facilities elements among food industries. Both qualitative and quantitative techniques are used as systematic tools. Design and facilities elements lay a firm foundation for good manufacturing practice to ensure food hygiene and should be used in conjunction with each specific code of hygiene practice and guidelines.

77 FR 27658 - Common Crop Insurance Regulations; Processing Sweet Corn Crop Insurance Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-11

... CFR part 400, subpart J for the informal administrative review process of good farming practices as... 7 CFR part 400, subpart J for determinations of good farming practices, as applicable, must be... farming operation. For instance, all producers are required to submit an application and acreage report to...

76 FR 71276 - Common Crop Insurance Regulations; Pecan Revenue Crop Insurance Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-17

... CFR part 400, subpart J for the informal administrative review process of good farming practices as... farming operation. For instance, all producers are required to submit an application and acreage report to... and discourages good management practices. Language in sections 3(d)(3) and 6(b) provides consequences...

Documentation: Records and Reports.

PubMed

Akers, Michael J

2017-01-01

This article deals with documentation to include the beginning of documentation, the requirements of Good Manufacturing Practice reports and records, and the steps that can be taken to minimize Good Manufacturing Practice documentation problems. It is important to remember that documentation for 503a compounding involves the Formulation Record, Compounding Record, Standard Operating Procedures, Safety Data Sheets, etc. For 503b outsourcing facilities, compliance with Current Good Manufacturing Practices is required, so this article is applicable to them. For 503a pharmacies, one can see the development and modification of Good Manufacturing Practice and even observe changes as they are occurring in 503a documentation requirements and anticipate that changes will probably continue to occur. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

40 CFR 160.81 - Standard operating procedures.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Standard operating procedures. 160.81... GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 160.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting forth study...

40 CFR 160.81 - Standard operating procedures.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Standard operating procedures. 160.81... GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 160.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting forth study...

40 CFR 160.81 - Standard operating procedures.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Standard operating procedures. 160.81... GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 160.81 Standard operating procedures. (a) A testing facility shall have standard operating procedures in writing setting forth study...

GUIDING PRINCIPLES FOR GOOD PRACTICES IN HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT UNITS.

PubMed

Sampietro-Colom, Laura; Lach, Krzysztof; Pasternack, Iris; Wasserfallen, Jean-Blaise; Cicchetti, Americo; Marchetti, Marco; Kidholm, Kristian; Arentz-Hansen, Helene; Rosenmöller, Magdalene; Wild, Claudia; Kahveci, Rabia; Ulst, Margus

2015-01-01

Health technology assessment (HTA) carried out for policy decision making has well-established principles unlike hospital-based HTA (HB-HTA), which differs from the former in the context characteristics and ways of operation. This study proposes principles for good practices in HB-HTA units. A framework for good practice criteria was built inspired by the EFQM excellence business model and information from six literature reviews, 107 face-to-face interviews, forty case studies, large-scale survey, focus group, Delphi survey, as well as local and international validation. In total, 385 people from twenty countries have participated in defining the principles for good practices in HB-HTA units. Fifteen guiding principles for good practices in HB-HTA units are grouped in four dimensions. Dimension 1 deals with principles of the assessment process aimed at providing contextualized information for hospital decision makers. Dimension 2 describes leadership, strategy and partnerships of HB-HTA units which govern and facilitate the assessment process. Dimension 3 focuses on adequate resources that ensure the operation of HB-HTA units. Dimension 4 deals with measuring the short- and long-term impact of the overall performance of HB-HTA units. Finally, nine core guiding principles were selected as essential requirements for HB-HTA units based on the expertise of the HB-HTA units participating in the project. Guiding principles for good practices set up a benchmark for HB-HTA because they represent the ideal performance of HB-HTA units; nevertheless, when performing HTA at hospital level, context also matters; therefore, they should be adapted to ensure their applicability in the local context.

40 CFR 60.1690 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2010 CFR

2010-07-01

... requirements for my municipal waste combustion unit? 60.1690 Section 60.1690 Protection of Environment... SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operating Requirements § 60.1690 What...

40 CFR 60.1690 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2014 CFR

2014-07-01

... requirements for my municipal waste combustion unit? 60.1690 Section 60.1690 Protection of Environment... SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operating Requirements § 60.1690 What...

40 CFR 60.1690 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2013 CFR

2013-07-01

... requirements for my municipal waste combustion unit? 60.1690 Section 60.1690 Protection of Environment... SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operating Requirements § 60.1690 What...

40 CFR 60.1690 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2011 CFR

2011-07-01

... requirements for my municipal waste combustion unit? 60.1690 Section 60.1690 Protection of Environment... SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operating Requirements § 60.1690 What...

40 CFR 60.1690 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2012 CFR

2012-07-01

... requirements for my municipal waste combustion unit? 60.1690 Section 60.1690 Protection of Environment... SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operating Requirements § 60.1690 What...

12 CFR 908.23 - Good faith certification.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 7 2011-01-01 2011-01-01 false Good faith certification. 908.23 Section 908.23... OPERATIONS RULES OF PRACTICE AND PROCEDURE IN HEARINGS ON THE RECORD General Rules § 908.23 Good faith... filing or submission of record is well-grounded in fact and is warranted by existing law or a good faith...

12 CFR 908.23 - Good faith certification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Good faith certification. 908.23 Section 908.23... OPERATIONS RULES OF PRACTICE AND PROCEDURE IN HEARINGS ON THE RECORD General Rules § 908.23 Good faith... filing or submission of record is well-grounded in fact and is warranted by existing law or a good faith...

40 CFR 160.49 - Laboratory operation areas.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Laboratory operation areas. 160.49 Section 160.49 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Facilities § 160.49 Laboratory operation areas. Separate laboratory...

40 CFR 160.49 - Laboratory operation areas.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Laboratory operation areas. 160.49 Section 160.49 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Facilities § 160.49 Laboratory operation areas. Separate laboratory...

Development and production of good manufacturing practice grade human embryonic stem cell lines as source material for clinical application.

PubMed

De Sousa, P A; Downie, J M; Tye, B J; Bruce, K; Dand, P; Dhanjal, S; Serhal, P; Harper, J; Turner, M; Bateman, M

2016-09-01

From 2006 to 2011, Roslin Cells Ltd derived 17 human embryonic stem cells (hESC) while developing (RCM1, RC-2 to -8, -10) and implementing (RC-9, -11 to -17) quality assured standards of operation in a facility operating in compliance with European Union (EU) directives and United Kingdom (UK) licensure for procurement, processing and storage of human cells as source material for clinical application, and targeted to comply with an EU Good Manufacturing Practice specification. Here we describe the evolution and specification of the facility, its operation and outputs, complementing hESC resource details communicated in Stem Cell Research Lab Resources. Copyright © 2016. Published by Elsevier B.V.

40 CFR 62.15135 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2014 CFR

2014-07-01

... certification, who may operate the municipal waste combustion unit? 62.15135 Section 62.15135 Protection of... Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operator Certification... combustion unit? After the required date for full or provisional certification, you must not operate your...

40 CFR 62.15135 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2012 CFR

2012-07-01

... certification, who may operate the municipal waste combustion unit? 62.15135 Section 62.15135 Protection of... Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operator Certification... combustion unit? After the required date for full or provisional certification, you must not operate your...

40 CFR 62.15135 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2013 CFR

2013-07-01

... certification, who may operate the municipal waste combustion unit? 62.15135 Section 62.15135 Protection of... Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operator Certification... combustion unit? After the required date for full or provisional certification, you must not operate your...

40 CFR 62.15135 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2011 CFR

2011-07-01

... certification, who may operate the municipal waste combustion unit? 62.15135 Section 62.15135 Protection of... Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operator Certification... combustion unit? After the required date for full or provisional certification, you must not operate your...

40 CFR 62.15135 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2010 CFR

2010-07-01

... certification, who may operate the municipal waste combustion unit? 62.15135 Section 62.15135 Protection of... Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operator Certification... combustion unit? After the required date for full or provisional certification, you must not operate your...

40 CFR 792.49 - Laboratory operation areas.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Laboratory operation areas. 792.49 Section 792.49 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.49 Laboratory operation areas...

Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research. The Chemical Manufacturers Association's Epidemiology Task Group.

PubMed

1991-12-01

The Guidelines for Good Epidemiology Practices (GEPs) for Occupational and Environmental Epidemiologic Research address the conduct of studies generally undertaken to answer questions about human health in relationship to the work place or the environment. The GEPs propose minimum practices and procedures that should be considered to help ensure the quality and integrity of data used in epidemiologic research and to provide adequate documentation of the research methods. The GEPs address the process of conducting individual epidemiologic studies and do not prescribe specific research methods. The Guidelines for Good Epidemiology Practices propose minimum practices and procedures in the following areas: I. Organization and Personnel II. Facilities, Resource Commitment, and Contractors III. Protocol IV. Review and Approval V. Study Conduct VI. Communication VII. Archiving VIII. Quality Assurance Although the Guidelines for Good Epidemiology Practices will not guarantee good epidemiology, they do provide a useful framework for ensuring that all research issues are adequately addressed. This framework is proposed as a first step in improving epidemiologic research practices through adherence to sound scientific research principles. Appendices provide an overview of standard operating procedures, a glossary of terms used in the Guidelines, and suggested references on occupational epidemiology methods.

Is operational research delivering the goods? The journey to success in low-income countries.

PubMed

Zachariah, Rony; Ford, Nathan; Maher, Dermot; Bissell, Karen; Van den Bergh, Rafael; van den Boogaard, Wilma; Reid, Tony; Castro, Kenneth G; Draguez, Bertrand; von Schreeb, Johan; Chakaya, Jeremiah; Atun, Rifat; Lienhardt, Christian; Enarson, Don A; Harries, Anthony D

2012-05-01

Operational research in low-income countries has a key role in filling the gap between what we know from research and what we do with that knowledge-the so-called know-do gap, or implementation gap. Planned research that does not tangibly affect policies and practices is ineffective and wasteful, especially in settings where resources are scarce and disease burden is high. Clear parameters are urgently needed to measure and judge the success of operational research. We define operational research and its relation with policy and practice, identify why operational research might fail to affect policy and practice, and offer possible solutions to address these shortcomings. We also propose measures of success for operational research. Adoption and use of these measures could help to ensure that operational research better changes policy and practice and improves health-care delivery and disease programmes. Copyright © 2012 Elsevier Ltd. All rights reserved.

40 CFR 60.1680 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2012 CFR

2012-07-01

... certification, who may operate the municipal waste combustion unit? 60.1680 Section 60.1680 Protection of... NEW STATIONARY SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operator...

40 CFR 60.1680 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2011 CFR

2011-07-01

... certification, who may operate the municipal waste combustion unit? 60.1680 Section 60.1680 Protection of... NEW STATIONARY SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operator...

40 CFR 60.1680 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2013 CFR

2013-07-01

... certification, who may operate the municipal waste combustion unit? 60.1680 Section 60.1680 Protection of... NEW STATIONARY SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operator...

40 CFR 60.1680 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2014 CFR

2014-07-01

... certification, who may operate the municipal waste combustion unit? 60.1680 Section 60.1680 Protection of... NEW STATIONARY SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operator...

40 CFR 60.1190 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2011 CFR

2011-07-01

... certification, who may operate the municipal waste combustion unit? 60.1190 Section 60.1190 Protection of... NEW STATIONARY SOURCES Standards of Performance for Small Municipal Waste Combustion Units for Which... June 6, 2001 Good Combustion Practices: Operator Certification § 60.1190 After the required date for...

40 CFR 60.1190 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2013 CFR

2013-07-01

... certification, who may operate the municipal waste combustion unit? 60.1190 Section 60.1190 Protection of... NEW STATIONARY SOURCES Standards of Performance for Small Municipal Waste Combustion Units for Which... June 6, 2001 Good Combustion Practices: Operator Certification § 60.1190 After the required date for...

40 CFR 60.1190 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2010 CFR

2010-07-01

... certification, who may operate the municipal waste combustion unit? 60.1190 Section 60.1190 Protection of... NEW STATIONARY SOURCES Standards of Performance for Small Municipal Waste Combustion Units for Which... June 6, 2001 Good Combustion Practices: Operator Certification § 60.1190 After the required date for...

40 CFR 60.1680 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2010 CFR

2010-07-01

... certification, who may operate the municipal waste combustion unit? 60.1680 Section 60.1680 Protection of... NEW STATIONARY SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operator...

40 CFR 60.1190 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2014 CFR

2014-07-01

... certification, who may operate the municipal waste combustion unit? 60.1190 Section 60.1190 Protection of... NEW STATIONARY SOURCES Standards of Performance for Small Municipal Waste Combustion Units for Which... June 6, 2001 Good Combustion Practices: Operator Certification § 60.1190 After the required date for...

40 CFR 60.1190 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2012 CFR

2012-07-01

... certification, who may operate the municipal waste combustion unit? 60.1190 Section 60.1190 Protection of... NEW STATIONARY SOURCES Standards of Performance for Small Municipal Waste Combustion Units for Which... June 6, 2001 Good Combustion Practices: Operator Certification § 60.1190 After the required date for...

40 CFR 792.49 - Laboratory operation areas.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 32 2011-07-01 2011-07-01 false Laboratory operation areas. 792.49... CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities § 792.49 Laboratory operation areas. Separate laboratory space and other space shall be provided, as needed, for the performance of the routine...

40 CFR 62.15130 - What types of operator certification must the chief facility operator and shift supervisor obtain...

Code of Federal Regulations, 2012 CFR

2012-07-01

... Requirements for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operator Certification § 62.15130 What types of operator certification must the chief....W. Alexander Drive, Room C521C, RTP, NC 27709 or at the National Archives and Records Administration...

40 CFR 62.15130 - What types of operator certification must the chief facility operator and shift supervisor obtain...

Code of Federal Regulations, 2010 CFR

2010-07-01

... Requirements for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operator Certification § 62.15130 What types of operator certification must the chief....W. Alexander Drive, Room C521C, RTP, NC 27709 or at the National Archives and Records Administration...

40 CFR 62.15130 - What types of operator certification must the chief facility operator and shift supervisor obtain...

Code of Federal Regulations, 2013 CFR

2013-07-01

... Requirements for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operator Certification § 62.15130 What types of operator certification must the chief....W. Alexander Drive, Room C521C, RTP, NC 27709 or at the National Archives and Records Administration...

40 CFR 62.15130 - What types of operator certification must the chief facility operator and shift supervisor obtain...

Code of Federal Regulations, 2011 CFR

2011-07-01

... Requirements for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operator Certification § 62.15130 What types of operator certification must the chief....W. Alexander Drive, Room C521C, RTP, NC 27709 or at the National Archives and Records Administration...

40 CFR 62.15130 - What types of operator certification must the chief facility operator and shift supervisor obtain...

Code of Federal Regulations, 2014 CFR

2014-07-01

... Requirements for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Good Combustion Practices: Operator Certification § 62.15130 What types of operator certification must the chief....W. Alexander Drive, Room C521C, RTP, NC 27709 or at the National Archives and Records Administration...

78 FR 17606 - Common Crop Insurance Regulations; Arizona-California Citrus Crop Insurance Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-22

... published at 7 CFR part 11, or 7 CFR part 400, subpart J for determinations of good farming practices, as... their farming operation. For instance, all producers are required to submit an application and acreage... category of ``practice'' in the actuarial documents with four categories named ``cropping practice...

Learning New Practices in Small Business: Engagement and Localised Support

ERIC Educational Resources Information Center

Ehrich, Lisa C.; Billett, Stephen

2004-01-01

Discusses the findings of a study that investigated how the learning of innovative practices might best proceed in small businesses. The recent implementation of the Goods and Service Tax (GST) in Australia presented an opportunity for understanding how small business operatives learned to implement a new practice. The procedures comprised…

40 CFR 792.35 - Quality assurance unit.

Code of Federal Regulations, 2010 CFR

2010-07-01

... from approved protocols or standard operating procedures were made without proper authorization and... standard operating procedures, and that the reported results accurately reflect the raw data of the study... ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Organization and Personnel § 792.35 Quality...

40 CFR 792.35 - Quality assurance unit.

Code of Federal Regulations, 2011 CFR

2011-07-01

... from approved protocols or standard operating procedures were made without proper authorization and... standard operating procedures, and that the reported results accurately reflect the raw data of the study... ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Organization and Personnel § 792.35 Quality...

40 CFR 792.35 - Quality assurance unit.

Code of Federal Regulations, 2012 CFR

2012-07-01

... from approved protocols or standard operating procedures were made without proper authorization and... standard operating procedures, and that the reported results accurately reflect the raw data of the study... ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Organization and Personnel § 792.35 Quality...

40 CFR 792.35 - Quality assurance unit.

Code of Federal Regulations, 2014 CFR

2014-07-01

... from approved protocols or standard operating procedures were made without proper authorization and... standard operating procedures, and that the reported results accurately reflect the raw data of the study... ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Organization and Personnel § 792.35 Quality...

40 CFR 792.35 - Quality assurance unit.

Code of Federal Regulations, 2013 CFR

2013-07-01

... from approved protocols or standard operating procedures were made without proper authorization and... standard operating procedures, and that the reported results accurately reflect the raw data of the study... ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Organization and Personnel § 792.35 Quality...

Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Final rule.

PubMed

2007-06-25

The Food and Drug Administration (FDA) is issuing a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements that we are taking to promote and protect the public health.

40 CFR 89.319 - Hydrocarbon analyzer calibration.

Code of Federal Regulations, 2011 CFR

2011-07-01

... approved in advance by the Administrator. (1) Follow good engineering practices for initial instrument.... (2) Optimize the FID's response on the most common operating range. The response is to be optimized... different hydrocarbon species that are expected to be in the exhaust. Good engineering judgment is to be...

78 FR 53370 - Common Crop Insurance Regulations; Forage Seed Crop Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-29

... process of good farming practices, as applicable, must be exhausted before any action against FCIC may be... for all producers regardless of the size of their farming operation. For instance, all producers are... guarantee per acre for each type and practice in the unit by the insured acreage of that type and practice...

Global perspectives on ensuring the safety of pharmaceutical products in the distribution process
.

PubMed

Jeong, Sohyun; Ji, Eunhee

2018-01-01

The distribution of counterfeit or falsified drugs is increasing worldwide. This can contribute to the high burden of disease and cost to society and is of global concern with the worldwide circulation of pharmaceuticals. The preparation and implementation of good distribution practice should be one of the most important aspects of ensuring safe drug circulation and administration. This research aimed to compare and analyze good distribution practice guidelines from advanced countries and international organizations, and to evaluate the status of the current good distribution practice guidelines in the world. Advanced pharmaceutical countries and international organizations, such as the World Health Organization, European Union, Pharmaceutical Inspection Co-operation Scheme, United States of America, Canada, and Australia, which have stable good distribution practice guidelines and public confidence, were included in the analysis. The World Health Organization and European Union guidelines are models for standardized good distribution practice for nations worldwide. The United States of America has a combination of four different series of distribution practices which have a unique structure and detailed content compared to those of other countries. The Canadian guidelines focus on temperature control during storage and transportation. The Australian guidelines apply to both classes of medicinal products and medical devices and need separate standardization. Transparent information about the Internet chain, international cooperation regarding counterfeiting, a high-standard qualification of sellers and customers, and technology to track and trace the whole life cycle of drugs should be the main focus of future good distribution practice guidelines worldwide.
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Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products.

PubMed

Tulina, M A; Pyatigorskaya, N V

2018-03-01

The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.

21 CFR 211.130 - Packaging and labeling operations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control § 211.130 Packaging and labeling operations. There shall be written procedures designed to... manufacture and control of the batch. (d) Examination of packaging and labeling materials for suitability and...

40 CFR 160.90 - Animal and other test system care.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 160.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing, feeding, handling, and... terrestrial amphibians used in laboratory procedures that require manipulations and observations over an...

40 CFR 792.90 - Animal and other test system care.

Code of Federal Regulations, 2014 CFR

2014-07-01

... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 792.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing... adult terrestrial amphibians used in laboratory procedures that require manipulations and observations...

40 CFR 160.90 - Animal and other test system care.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 160.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing, feeding, handling, and... terrestrial amphibians used in laboratory procedures that require manipulations and observations over an...

40 CFR 160.90 - Animal and other test system care.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 160.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing, feeding, handling, and... terrestrial amphibians used in laboratory procedures that require manipulations and observations over an...

40 CFR 792.90 - Animal and other test system care.

Code of Federal Regulations, 2013 CFR

2013-07-01

... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 792.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing... adult terrestrial amphibians used in laboratory procedures that require manipulations and observations...

40 CFR 792.90 - Animal and other test system care.

Code of Federal Regulations, 2011 CFR

2011-07-01

... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 792.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing... adult terrestrial amphibians used in laboratory procedures that require manipulations and observations...

40 CFR 160.90 - Animal and other test system care.

Code of Federal Regulations, 2012 CFR

2012-07-01

... PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 160.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing, feeding, handling, and... terrestrial amphibians used in laboratory procedures that require manipulations and observations over an...

40 CFR 792.90 - Animal and other test system care.

Code of Federal Regulations, 2012 CFR

2012-07-01

... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 792.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing... adult terrestrial amphibians used in laboratory procedures that require manipulations and observations...

40 CFR 792.90 - Animal and other test system care.

Code of Federal Regulations, 2010 CFR

2010-07-01

... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 792.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing... adult terrestrial amphibians used in laboratory procedures that require manipulations and observations...

40 CFR 160.90 - Animal and other test system care.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 160.90 Animal and other test system care. (a) There shall be standard operating procedures for the housing, feeding, handling, and... terrestrial amphibians used in laboratory procedures that require manipulations and observations over an...

Guide of good practices for occupational radiological protection in plutonium facilities

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

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 TSmore » 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.« less

Building a successful trauma practice in a community setting.

PubMed

Althausen, Peter L

2011-12-01

The development of a busy community-based trauma practice is a multifaceted endeavor that requires good clinical judgment, business acumen, interpersonal skills, and negotiation tactics. Private practice is a world in which perfect outcomes are expected and efficiency is paramount. Successful operative outcomes are dependent on solid clinical training, good preoperative planning, and communication with mentors when necessary. Private practitioners must display confidence, polite behavior, and promptness. Maintaining availability for consultation from emergency room physicians, private practice physicians, and local orthopaedic surgeons is a powerful marketing tool. Orthopaedic trauma surgery has been shown to be a profitable field for hospitals and private practitioners. However, physician success depends on a sound understanding of hospital finance, marketing skills, and knowledge of billing and coding. As the financial pressures of medical care increase, hospital negotiation will be paramount, and private practitioners must combine clinical and business skills to provide good patient care while maintaining independence and financial security.

25 CFR 213.40 - Cancellations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... FIVE CIVILIZED TRIBES, OKLAHOMA, FOR MINING Operations § 213.40 Cancellations. (a) When, in the opinion... or of the applicable regulations, or if mining operations are conducted wastefully and without regard to good mining practice, the Secretary of the Interior shall have the right at any time after 30 days...

40 CFR 63.11115 - What are my general duties to minimize emissions?

Code of Federal Regulations, 2014 CFR

2014-07-01

... Dispensing Facilities Emission Limitations and Management Practices § 63.11115 What are my general duties to... consistent with safety and good air pollution control practices for minimizing emissions. Determination of... and maintenance procedures, review of operation and maintenance records, and inspection of the source...

40 CFR 63.11115 - What are my general duties to minimize emissions?

Code of Federal Regulations, 2012 CFR

2012-07-01

... Dispensing Facilities Emission Limitations and Management Practices § 63.11115 What are my general duties to... consistent with safety and good air pollution control practices for minimizing emissions. Determination of... and maintenance procedures, review of operation and maintenance records, and inspection of the source...

40 CFR 63.11115 - What are my general duties to minimize emissions?

Code of Federal Regulations, 2011 CFR

2011-07-01

... Dispensing Facilities Emission Limitations and Management Practices § 63.11115 What are my general duties to... consistent with safety and good air pollution control practices for minimizing emissions. Determination of... and maintenance procedures, review of operation and maintenance records, and inspection of the source...

Sanitation & Safety for Child Feeding Programs.

ERIC Educational Resources Information Center

Florida State Dept. of Health and Rehabilitative Services, Tallahassee.

In the interest of promoting good health, sanitation, and safety practices in the operation of child feeding programs, this bulletin discusses practices in personal grooming and wearing apparel; the purchasing, storage, handling, and serving of food; sanitizing equipment and utensils; procedures to follow in case of a food poisoning outbreak; some…

76 FR 43606 - Common Crop Insurance Regulations; Onion Crop Insurance Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-21

... CFR part 400, subpart J for the informal administrative review process of good farming practices as... farming operation. For instance, all producers are required to submit an application and acreage report to... prepared for the planting method and production practice. * * * * * Onion production. Onions with excess...

75 FR 52218 - Common Crop Insurance Regulations; Apple Crop Insurance Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-25

... the definition of ``good farming practices'' in the Basic Provisions. Comment: Several comments were... farming operation. For instance, all producers are required to submit an application and acreage report to... practices generally in use for fresh apple acreage in the county as determined by agricultural experts'' is...

77 FR 52587 - Common Crop Insurance Regulations; Peach Crop Insurance Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

... review process of good farming practices as applicable, must be exhausted before any action against FCIC... insurance program are the same for all producers regardless of the size of their farming operation. For... have the experience to grow and to follow cultural practices appropriate to produce fresh peaches...

77 FR 13961 - Common Crop Insurance Regulations; Onion Crop Insurance Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-08

... good farming practices, as applicable, must be exhausted before any action against FCIC for judicial... for all producers regardless of the size of their farming operation. For instance, all producers are... practices of planting such as direct seeded and transplanted. The onion crop is planted earlier for the...

40 CFR 792.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2011 CFR

2011-07-01

... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

40 CFR 792.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2014 CFR

2014-07-01

... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

40 CFR 792.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2013 CFR

2013-07-01

... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

40 CFR 792.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2012 CFR

2012-07-01

... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

21 CFR 26.11 - Start of operational period.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Start of operational period. 26.11 Section 26.11 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

40 CFR 792.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... according to written standard operating procedures, which provide for periodic analysis of each batch. (b... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances...

40 CFR 792.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2011 CFR

2011-07-01

... according to written standard operating procedures, which provide for periodic analysis of each batch. (b... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances...

40 CFR 792.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... according to written standard operating procedures, which provide for periodic analysis of each batch. (b... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances...

40 CFR 792.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... according to written standard operating procedures, which provide for periodic analysis of each batch. (b... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances...

A Study of State Tax Appropriations for Capital Needs in U.S. Public Higher Education

ERIC Educational Resources Information Center

Harris, Delphine; Manns, Derrick; Katsinas, Stephen

2012-01-01

This study investigated the relationship of key issues related to capital and operating budget practices of state tax appropriations and policies at the state level, including new facilities construction, renovation, replacement and renewal which may exist between and among states by governance structure. Recognized "good practices" in…

A Wiki Collaboration to Create National Guidelines: Tips for Professional Practice

ERIC Educational Resources Information Center

Moser, Patt

2009-01-01

In 2006, technology directors from independent schools across the country had banded together and created "Principles of Good Practice" for technology in independent schools. These principles "define high standards and ethical behavior in key areas of independent school operations" (NAIS 2006). This author decided that it was time for the National…

40 CFR 63.11148 - What are the standards and compliance requirements for existing sources using batch copper...

Code of Federal Regulations, 2013 CFR

2013-07-01

... acid plant prior to discharge to the atmosphere. (iv) For each secondary capture system that is used to... practicable, maintain and operate any affected source, including associated air pollution control equipment, in a manner consistent with good air pollution control practice for minimizing emissions...

40 CFR 63.11148 - What are the standards and compliance requirements for existing sources using batch copper...

Code of Federal Regulations, 2014 CFR

2014-07-01

... acid plant prior to discharge to the atmosphere. (iv) For each secondary capture system that is used to... practicable, maintain and operate any affected source, including associated air pollution control equipment, in a manner consistent with good air pollution control practice for minimizing emissions...

40 CFR 63.11148 - What are the standards and compliance requirements for existing sources using batch copper...

Code of Federal Regulations, 2011 CFR

2011-07-01

... acid plant prior to discharge to the atmosphere. (iv) For each secondary capture system that is used to... practicable, maintain and operate any affected source, including associated air pollution control equipment, in a manner consistent with good air pollution control practice for minimizing emissions...

40 CFR 63.11148 - What are the standards and compliance requirements for existing sources using batch copper...

Code of Federal Regulations, 2010 CFR

2010-07-01

... acid plant prior to discharge to the atmosphere. (iv) For each secondary capture system that is used to... practicable, maintain and operate any affected source, including associated air pollution control equipment, in a manner consistent with good air pollution control practice for minimizing emissions...

40 CFR 63.11148 - What are the standards and compliance requirements for existing sources using batch copper...

Code of Federal Regulations, 2012 CFR

2012-07-01

... acid plant prior to discharge to the atmosphere. (iv) For each secondary capture system that is used to... practicable, maintain and operate any affected source, including associated air pollution control equipment, in a manner consistent with good air pollution control practice for minimizing emissions...

77 FR 59045 - Common Crop Insurance Regulations; Prune Crop Insurance Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-26

... part 11, or 7 CFR part 400, subpart J for determinations of good farming practices, as applicable, must... farming operation. For instance, all producers are required to submit an application and acreage report to... Producer's Pre-Acceptance Worksheet (PAW) as they have performed cultural practices that will reduce the...

75 FR 15603 - Common Crop Insurance Regulations; Florida Avocado Crop Insurance Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-30

... administrative review process of good farming practices, as applicable, must be exhausted before any action... farming operation. For instance, all producers are required to submit an application and acreage report to...; damage; or a change in practices on yield potential of the insured crop could provide a wide range of...

Practical Study for the Properties of Hueckel Edge Detection Operator

NASA Astrophysics Data System (ADS)

Jabbar, Hameed M. Abdul; Hatem, Amal J.; Ameer, Inbethaq M. A. Abdul

2018-05-01

The first practical study for the Hueckel edge detection operator was presented in this research, where it is tested on standard step edge set images. A number of criteria were adopted to evaluate its practical performance, which is the accuracy in detecting the edges direction, the error in the edges location (dislocation), edges width, the calculated edge goodness criterion and the consumed execution time. These criteria were studied with the edge direction and the used disk radius of the Hueckel edge detection operator. Important notes were recorded for the performance of this operator depending on the direction of the edge and/or with the radius of the used disk. There is a variation in the performance of the operator in terms of precision in detecting of the edges direction and position. A discussion was presented for the all criteria adopted in the research.

40 CFR 60.564 - Test methods and procedures.

Code of Federal Regulations, 2014 CFR

2014-07-01

... the Administrator. If the carrier component of the gas stream is nitrogen, then an average molecular... from materials balance by good engineering practice. (i) The owner or operator shall determine...

Computer Drawing Method for Operating Characteristic Curve of PV Power Plant Array Unit

NASA Astrophysics Data System (ADS)

Tan, Jianbin

2018-02-01

According to the engineering design of large-scale grid-connected photovoltaic power stations and the research and development of many simulation and analysis systems, it is necessary to draw a good computer graphics of the operating characteristic curves of photovoltaic array elements and to propose a good segmentation non-linear interpolation algorithm. In the calculation method, Component performance parameters as the main design basis, the computer can get 5 PV module performances. At the same time, combined with the PV array series and parallel connection, the computer drawing of the performance curve of the PV array unit can be realized. At the same time, the specific data onto the module of PV development software can be calculated, and the good operation of PV array unit can be improved on practical application.

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2014 CFR

2014-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2010 CFR

2010-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2011 CFR

2011-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

40 CFR 160.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2012 CFR

2012-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

40 CFR 160.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

40 CFR 160.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2011 CFR

2011-07-01

... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

40 CFR 160.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2010 CFR

2010-07-01

... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

40 CFR 160.113 - Mixtures of substances with carriers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

40 CFR 160.105 - Test, control, and reference substance characterization.

Code of Federal Regulations, 2013 CFR

2013-07-01

... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

40 CFR 60.564 - Test methods and procedures.

Code of Federal Regulations, 2013 CFR

2013-07-01

.... If the carrier component of the gas stream is nitrogen, then an average molecular weight of 28 g/g... from materials balance by good engineering practice. (i) The owner or operator shall determine...

40 CFR 60.564 - Test methods and procedures.

Code of Federal Regulations, 2012 CFR

2012-07-01

.... If the carrier component of the gas stream is nitrogen, then an average molecular weight of 28 g/g... from materials balance by good engineering practice. (i) The owner or operator shall determine...

40 CFR 60.564 - Test methods and procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... If the carrier component of the gas stream is nitrogen, then an average molecular weight of 28 g/g... from materials balance by good engineering practice. (i) The owner or operator shall determine...

40 CFR 60.564 - Test methods and procedures.

Code of Federal Regulations, 2011 CFR

2011-07-01

.... If the carrier component of the gas stream is nitrogen, then an average molecular weight of 28 g/g... from materials balance by good engineering practice. (i) The owner or operator shall determine...

40 CFR 86.1324-84 - Carbon dioxide analyzer calibration.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Exhaust Test Procedures § 86.1324-84 Carbon dioxide analyzer calibration. Prior to its introduction into...) Follow good engineering practices for instrument start-up and operation. Adjust the analyzer to optimize...

Integrating standard operating procedures and industry notebook standards to evaluate students in laboratory courses.

PubMed

Wallert, Mark A; Provost, Joseph J

2014-01-01

To enhance the preparedness of graduates from the Biochemistry and Biotechnology (BCBT) Major at Minnesota State University Moorhead for employment in the bioscience industry we have developed a new Industry certificate program. The BCBT Industry Certificate was developed to address specific skill sets that local, regional, and national industry experts identified as lacking in new B.S. and B.A. biochemistry graduates. The industry certificate addresses concerns related to working in a regulated industry such as Good Laboratory Practices, Good Manufacturing Practices, and working in a Quality System. In this article we specifically describe how we developed a validation course that uses Standard Operating Procedures to describe grading policy and laboratory notebook requirements in an effort to better prepare students to transition into industry careers. © 2013 by The International Union of Biochemistry and Molecular Biology.

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.

Health and Safety Guide for K-12 Schools in Washington.

ERIC Educational Resources Information Center

Ellis, Richard E.; Kerns, James T.; Currie, Michael

This guide, which can be used as a school self-inspection tool, is designed to help Washington's K-12 public schools prevent and reduce injuries and illnesses by focusing on good health and safety practices. The guide also focuses on practices that can be undertaken during the design, construction, renovation, operation, maintenance, or inspection…

76 FR 44199 - Area Risk Protection Insurance Regulations and Area Risk Protection Insurance Crop Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

... CFR part 400, subpart J for the informal administrative review process of good farming practices as... their farming operation. For instance, all producers are required to submit an application and acreage... practice basis, as shown on the Special Provisions. If an expected county yield is not published in the...

77 FR 75509 - Common Crop Insurance Regulations; Florida Citrus Fruit Crop Insurance Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

... part 11, or 7 CFR part 400, subpart J for determinations of good farming practices, as applicable, must... farming operation. For instance, all producers are required to submit an application and acreage report to... to the expansion of type and practice into four different new subcategories for each of these items...

Implementation of the OECD principles of good laboratory practice in test facilities complying with a quality system accredited to the ISO/IEC 17025 standard.

PubMed

Feller, Etty

2008-01-01

Laboratories with a quality system accredited to the ISO/IEC 17025 standard have a definite advantage, compared to non-accredited laboratories, when preparing their facilities for the implementation of the principles of good laboratory practice (GLP) of the Organisation for Economic Co-operation and Development (OECD). Accredited laboratories have an established quality system covering the administrative and technical issues specified in the standard. The similarities and differences between the ISO/IEC 17025 standard and the OECD principles of GLP are compared and discussed.

Safety and compliance-related hazards in the medical practice: Part one.

PubMed

Calway, R C

2001-01-01

Safety and risk management hazards are a fact of life for the medical practice, and the costs of these incidents can place the group at significant risk of liability. Good compliance and risk management programs help minimize these incidents, improve staff morale, increase a practice's visibility in the community, and positively affect the practice's financial and operational bottom line performance. Medical practices that implement effective safety and risk management programs can realize savings in staffing costs, operational efficiency, morale, insurance premiums, and improved third-party relationships while at the same time avoiding embarrassing risks, fines, and liability. This article outlines some of the most common safety and risk management-related deficiencies seen in medical practices today. The author explains how to remedy these deficiencies and provides a self-test tool to enable the reader to assess areas within his or her own practice in need of attention.

Analysis of good practice of public health Emergency Operations Centers.

PubMed

Xu, Min; Li, Shi-Xue

2015-08-01

To study the public health Emergency Operations Centers (EOCs)in the US, the European Union, the UK and Australia, and summarize the good practice for the improvement of National Health Emergency Response Command Center in Chinese National Health and Family Planning Commission. Literature review was conducted to explore the EOCs of selected countries. The study focused on EOC function, organizational structure, human resources and information management. The selected EOCs had the basic EOC functions of coordinating and commanding as well as the public health related functions such as monitoring the situation, risk assessment, and epidemiological briefings. The organizational structures of the EOCs were standardized, scalable and flexible. Incident Command System was the widely applied organizational structure with a strong preference. The EOCs were managed by a unit of emergency management during routine time and surge staff were engaged upon emergencies. The selected EOCs had clear information management framework including information collection, assessment and dissemination. The performance of National Health Emergency Response Command Center can be improved by learning from the good practice of the selected EOCs, including setting clear functions, standardizing the organizational structure, enhancing the human resource capacity and strengthening information management. Copyright © 2015 Hainan Medical College. Production and hosting by Elsevier B.V. All rights reserved.

Surveillance of Environmental and Procedural Measures of Infection Control in the Operating Theatre Setting

PubMed Central

Raggi, Alessandra; Sanna, Tiziana; Mazzetti, Magda; Orsi, Alessandra; Zanni, Angela; Farruggia, Patrizia

2017-01-01

The microbiological contamination of operating theatres and the lack of adherence to best practices by surgical staff represent some of the factors affecting Surgical Site Infections (SSIs). The aim of the present study was to assess the microbiological quality of operating settings and the staff compliance to the SSI evidence-based control measures. Ten operating rooms were examined for microbiological contamination of air and surfaces, after cleaning procedures, in “at rest” conditions. Furthermore, 10 surgical operations were monitored to assess staff compliance to the recommended practices. None of the air samples exceeded microbiological reference standards and only six of the 200 surface samples (3.0%) were slightly above recommended levels. Potentially pathogenic bacteria and moulds were never detected. Staff compliance to best practices varied depending on the type of behaviour investigated and the role of the operator. The major not compliant behaviours were: pre-operative skin antisepsis, crowding of the operating room and hand hygiene of the anaesthetist. The good environmental microbiological quality observed is indicative of the efficacy of the cleaning-sanitization procedures adopted. The major critical point was staff compliance to recommended practices. Awareness campaigns are therefore necessary, aimed at improving the organisation of work so as to facilitate compliance to operative protocols. PMID:29283367

How shift scheduling practices contribute to fatigue amongst freight rail operating employees: Findings from Canadian accident investigations.

PubMed

Rudin-Brown, Christina M; Harris, Sarah; Rosberg, Ari

2018-02-01

Canada's freight rail system moves 70% of the country's surface goods and almost half of all exports (RAC, 2016). These include dangerous goods. Anonymous survey of freight rail operating employees conducted by the Teamsters Canada Rail Conference (TCRC, 2014) revealed that many do not report getting enough sleep because of their work schedules, and that fatigue may be affecting their performance at work. Besides general impairments in attention and cognitive functioning, fatigue in railway operating employees slows reaction time to safety alarms and impairs conformance to train operating requirements. Shift scheduling practices can contribute to sleep-related fatigue by restricting sleep opportunities, requiring extended periods of wakefulness and by disrupting daily (circadian) rhythms. The primary goal of accident investigation is to identify causal and contributing factors so that similar occurrences can be prevented. A database search of Transportation Safety Board (TSB) rail investigation reports published in the 21-year period from 1995 to 2015 identified 18 that cited sleep-related fatigue of freight rail operating employees as a causal, contributing, or risk finding. This number represents about 20% of TSB rail investigations from the same period in which a human factors aspect of freight train activities was a primary cause. Exploration of accident themes suggests that management of fatigue and shift scheduling in the freight rail industry is a complex issue that is often not conducive to employee circadian rhythms and sleep requirements. It also suggests that current shift scheduling and fatigue management practices may be insufficient to mitigate the associated safety risk. Railway fatigue management systems that are based on the principles of modern sleep science are needed to improve scheduling practices and mitigate the ongoing safety risk. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

[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.

Good practices in health care "management experimentation models": insights from an international public-private partnership on transplantation and advanced specialized therapies.

PubMed

Longo, Maria Cristina

2015-01-01

The research analyzes good practices in health care "management experimentation models," which fall within the broader range of the integrative public-private partnerships (PPPs). Introduced by the Italian National Healthcare System in 1991, the "management experimentation models" are based on a public governance system mixed with a private management approach, a patient-centric orientation, a shared financial risk, and payment mechanisms correlated with clinical outcomes, quality, and cost-savings. This model makes public hospitals more competitive and efficient without affecting the principles of universal coverage, solidarity, and equity of access, but requires higher financial responsibility for managers and more flexibility in operations. In Italy the experience of such experimental models is limited but successful. The study adopts the case study methodology and refers to the international collaboration started in 1997 between two Italian hospitals and the University of Pittsburgh Medical Center (UPMC - Pennsylvania, USA) in the field of organ transplants and biomedical advanced therapies. The research allows identifying what constitutes good management practices and factors associated with higher clinical performance. Thus, it allows to understand whether and how the management experimentation model can be implemented on a broader basis, both nationwide and internationally. However, the implementation of integrative PPPs requires strategic, cultural, and managerial changes in the way in which a hospital operates; these transformations are not always sustainable. The recognition of ISMETT's good management practices is useful for competitive benchmarking among hospitals specialized in organ transplants and for its insights on the strategies concerning the governance reorganization in the hospital setting. Findings can be used in the future for analyzing the cross-country differences in productivity among well-managed public hospitals.

Progress and challenges associated with halal authentication of consumer packaged goods.

PubMed

Premanandh, Jagadeesan; Bin Salem, Samara

2017-11-01

Abusive business practices are increasingly evident in consumer packaged goods. Although consumers have the right to protect themselves against such practices, rapid urbanization and industrialization result in greater distances between producers and consumers, raising serious concerns on the supply chain. The operational complexities surrounding halal authentication pose serious challenges on the integrity of consumer packaged goods. This article attempts to address the progress and challenges associated with halal authentication. Advancement and concerns on the application of new, rapid analytical methods for halal authentication are discussed. The significance of zero tolerance policy in consumer packaged foods and its impact on analytical testing are presented. The role of halal assurance systems and their challenges are also considered. In conclusion, consensus on the establishment of one standard approach coupled with a sound traceability system and constant monitoring would certainly improve and ensure halalness of consumer packaged goods. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

78 FR 55171 - Common Crop Insurance Regulations; Processing Sweet Corn Crop Insurance Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-10

... good farming practices, as applicable, must be exhausted before any action against FCIC for judicial... insurance program are the same for all producers regardless of the size of their farming operation. For...

Petition to request an exemption from 100 percent identity testing of dietary ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Interim final rule.

PubMed

2007-06-25

The Food and Drug Administration (FDA) is issuing an interim final rule (IFR) that sets forth a procedure for requesting an exemption from the requirement in the final rule "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements," published elsewhere in this issue of the Federal Register, that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met and establishes a requirement for retention of records relating to the FDA's response to an exemption request.

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

PubMed

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

2014-07-01

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. © 2013.

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 involvement and support through economic benefits and environmental safeguards; develop options for the concerns resolution. Difficulties in establishing the GNA standards include lack of insurance/bonding policies, and by the lack of audit and monitoring that could determine the level of exposure of the local community and the environment to the contaminants released at the mine sites. Since many problems of mines can occur during closure and post-closure, GNA's should address those issues also. The goal of the GNA is to have open access for the public to the safety, health, and environmental information pertaining to the mining operation, as well as to educate the local communities about mining practices that promote mutual acknowledgment of the need to build a relationship amenable to each other's needs. Frequent conflicts between mining companies and surrounding communities lead to work disruptions or even mine closures and show the necessity of a less confrontational approach to environmental and social justice. The Good Neighbor Agreement is a unique way to provide the benefits for the both mining operations and local community to provide a mechanism for risk redaction and communication that offer the potential to protect both mining and community interests.

Lease Operations Environmental Guidance Document

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bureau of Land Management

This report contains discussions in nine different areas as follows: (1) Good Lease Operating Practices; (2) Site Assessment and Sampling; (3) Spills/Accidents; (4) Containment and Disposal of Produced Waters; (5) Restoration of Hydrocarbon Impacted Soils; (6) Restoration of Salt Impacted Soils; (7) Pit Closures; (8) Identification, Removal and Disposal of Naturally Occurring Radioactive Materials (NORM); and (9) Site Closure and Construction Methods for Abandonment Wells/Locations. This report is primary directed towards the operation of oil and gas producing wells.

Management practices in substance abuse treatment programs.

PubMed

McConnell, K John; Hoffman, Kim A; Quanbeck, Andrew; McCarty, Dennis

2009-07-01

Efforts to understand how to improve the delivery of substance abuse treatment have led to a recent call for studies on the "business of addiction treatment." This study adapts an innovative survey tool to collect baseline management practice data from 147 addiction treatment programs enrolled in the Network for the Improvement of Addiction Treatment 200 project. Measures of "good" management practice were strongly associated with days to treatment admission. Management practice scores were weakly associated with revenues per employee but were not correlated with operating margins. Better management practices were more prevalent among programs with a higher number of competitors in their catchment area.

21 CFR 110.80 - Processes and controls.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD Production and Process Controls § 110.80 Processes and controls. All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in...

21 CFR 26.40 - Start of the operational period.

Code of Federal Regulations, 2010 CFR

2010-04-01

... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN... to quality system evaluation reports and product evaluation reports generated by CAB's listed in...

Confidence Intervals for the Probability of Superiority Effect Size Measure and the Area under a Receiver Operating Characteristic Curve

ERIC Educational Resources Information Center

Ruscio, John; Mullen, Tara

2012-01-01

It is good scientific practice to the report an appropriate estimate of effect size and a confidence interval (CI) to indicate the precision with which a population effect was estimated. For comparisons of 2 independent groups, a probability-based effect size estimator (A) that is equal to the area under a receiver operating characteristic curve…

The Saudi Arabia Food and Drug Authority: An Evaluation of the Registration Process and Good Review Practices in Saudi Arabia in Comparison with Australia, Canada and Singapore.

PubMed

Hashan, Hajed; Aljuffali, Ibrahim; Patel, Prisha; Walker, Stuart

This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, and Singapore and identifies opportunities for developing the SFDA as a Regional Centre of Excellence. A questionnaire completed by the SFDA included data regarding the organisation, key milestones, review timelines, and good review practices of the agency. Similar information was obtained within the same timeframe (2014/2015) through the same standard questionnaire regarding the processes and practices for Health Canada, Singapore's Health Sciences Authority, and Australia's Therapeutic Goods Administration. All four regulatory agencies have established target times for scientific assessment and regulatory review, examine dossier sections in parallel, and separate company response time from overall timing. Additionally, all four agencies have instituted good review practices including standard operating procedures, templates, dossier monitoring, and continuous improvement processes, and assign a high priority to transparency in their relationships with the public, healthcare professionals and industry. Of the four agencies, however, only the SFDA requires a Certificate of Pharmaceutical Product (CPP) at the time of the submission and pricing negotiations before final product approval. To assist the SFDA in its efforts to become a Regional Centre of Excellence, it is suggested that the agency explore a risk stratification approach to select dossiers for verification, abridged, or full reviews; use forms of certification other than the CPP; make pricing negotiations independent to the review process; and introduce a feedback process for the quality of the dossier.

40 CFR 792.83 - Reagents and solutions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Reagents and solutions. 792.83 Section 792.83 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 792.83 Reagents and...

40 CFR 63.1544 - Standards for fugitive dust sources.

Code of Federal Regulations, 2014 CFR

2014-07-01

... associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. Determination of whether such operation.... 63.1544 Section 63.1544 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR...

40 CFR 63.1544 - Standards for fugitive dust sources.

Code of Federal Regulations, 2012 CFR

2012-07-01

... associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. Determination of whether such operation.... 63.1544 Section 63.1544 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR...

40 CFR 63.1544 - Standards for fugitive dust sources.

Code of Federal Regulations, 2013 CFR

2013-07-01

... associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. Determination of whether such operation....1544 Section 63.1544 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS...

21 CFR 110.10 - Personnel.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General... contamination of food. The methods for maintaining cleanliness include, but are not limited to: (1) Wearing outer garments suitable to the operation in a manner that protects against the contamination of food...

21 CFR 58.83 - Reagents and solutions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.83 Reagents and solutions. All reagents and solutions in the laboratory areas shall be labeled to indicate identity, titer...

Prediction of wastewater treatment plants performance based on artificial fish school neural network

NASA Astrophysics Data System (ADS)

Zhang, Ruicheng; Li, Chong

2011-10-01

A reliable model for wastewater treatment plant is essential in providing a tool for predicting its performance and to form a basis for controlling the operation of the process. This would minimize the operation costs and assess the stability of environmental balance. For the multi-variable, uncertainty, non-linear characteristics of the wastewater treatment system, an artificial fish school neural network prediction model is established standing on actual operation data in the wastewater treatment system. The model overcomes several disadvantages of the conventional BP neural network. The results of model calculation show that the predicted value can better match measured value, played an effect on simulating and predicting and be able to optimize the operation status. The establishment of the predicting model provides a simple and practical way for the operation and management in wastewater treatment plant, and has good research and engineering practical value.

Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls--FDA. Final rule.

PubMed

1993-08-03

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human and veterinary drug products to revise certain labeling control provisions. Specifically, the final rule defines the term "gang-printed labeling," specifies conditions for the use of gang-printed or cut labeling, exempts manufacturers that employ automated 100-percent labeling inspection systems from CGMP labeling reconciliation requirements, and requires manufacturers to identify filled drug product containers that are set aside and held in an unlabeled condition for future labeling operations. These changes are intended to reduce the frequency of drug product mislabeling and associated drug product recalls.

Should biodiversity and nature have to earn their keep? What it really means to bring environmental goods into the marketplace.

PubMed

Maier, Donald S

2018-05-01

Pursuit of economic gain has sponsored much of our planet's despoliation. Yet conservation increasingly operates as an economic sector that markets biodiversity, ecosystems, and nature as natural capital, service provider, or option value. This essay first elucidates what basic moral theory says about the principle that the goodness of biodiversity and nature is largely economic. It explains why economic valuations may be morally unimportant, inapt for environmental goods, and subversive of more important ideals. It also shows why neither econometric notions of option value nor Daniel Faith's qualitative one credibly applies. The essay then turns to what an economic conception of goodness implies for conservation practice. It refers to two prominent conservation organizations, whose conservation principles match the market-based ones of the World Business Council on Sustainable Development's. The environmental record of the latter organization's practices according to these principles predicts what their adoption for conservation entails.

Refactoring affordances in corporate wikis: a case for the use of mind maps

NASA Astrophysics Data System (ADS)

Puente, Gorka; Díaz, Oscar; Azanza, Maider

2015-11-01

The organisation of corporate wikis tends to deteriorate as time goes by. Rearranging categories, structuring articles and even moving sections among articles are cumbersome tasks in current wiki engines. This discourages the layman. But, it is the layman who writes the articles, knows the wiki content and detects refactoring opportunities. Our goal is to improve the refactoring affordances of current wiki engines by providing an alternative front-end tuned to refactoring. This is achieved by (1) surfacing the structure of the wiki corpus as a mind map, and (2) conducting refactoring as mind map reshaping. To this end, we introduce WikiWhirl, a domain-specific language for wiki refactoring. WikiWhirl is supported as an extension of FreeMind, a popular mind mapping tool. In this way, refactoring operations are intuitively conducted as actions upon mind map nodes. In a refactoring session a user imports the wiki structure as a FreeMind map; next, conducts the refactoring operations on the map, and finally, the effects are saved in the wiki database. The operational semantics of the WikiWhirl operations follow refactoring good practices (e.g., authorship preservation). Results from a controlled experiment suggest that WikiWhirl outperforms MediaWiki in three main affordance enablers: understandability, productivity and fulfillment of refactoring good practices.

40 CFR 160.83 - Reagents and solutions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Reagents and solutions. 160.83 Section 160.83 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Testing Facilities Operation § 160.83 Reagents and solutions. All reagents and...

21 CFR 110.35 - Sanitary operations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... against contamination of food. (1) Food-contact surfaces used for manufacturing or holding low-moisture... HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD... for contamination. Only the following toxic materials may be used or stored in a plant where food is...

Evaluation of Iron Loss in Interior Permanent Magnet Synchronous Motor with Consideration of Rotational Field

NASA Astrophysics Data System (ADS)

Ma, Lei; Sanada, Masayuki; Morimoto, Shigeo; Takeda, Yoji; Kaido, Chikara; Wakisaka, Takeaki

Loss evaluation is an important issue in the design of electrical machines. Due to the complicate structure and flux distribution, it is difficult to predict the iron loss in the machines exactly. This paper studies the iron loss in interior permanent magnet synchronous motors based on the finite element method. The iron loss test data of core material are used in the fitting of the hysteresis and eddy current loss constants. For motors in practical operation, additional iron losses due to the appearance of rotation of flux density vector and harmonic flux density distribution makes the calculation data deviates from the measured ones. Revision is made to account for these excess iron losses which exist in the practical operating condition. Calculation results show good consistence with the experimental ones. The proposed method provides a possible way to predict the iron loss of the electrical machine with good precision, and may be helpful in the selection of the core material which is best suitable for a certain machine.

21 CFR 111.16 - What are the requirements under this subpart C for written procedures?

Code of Federal Regulations, 2010 CFR

2010-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical Plant and Grounds... follow written procedures for cleaning the physical plant and for pest control. ...

21 CFR 111.16 - What are the requirements under this subpart C for written procedures?

Code of Federal Regulations, 2011 CFR

2011-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical Plant and Grounds... follow written procedures for cleaning the physical plant and for pest control. ...

Research to policy and practice change: is capacity building in operational research delivering the goods?

PubMed

Zachariah, Rony; Guillerm, Nathalie; Berger, Selma; Kumar, Ajay M V; Satyanarayana, Srinath; Bissell, Karen; Edginton, Mary; Hinderaker, Sven Gudmund; Tayler-Smith, Katie; Van den Bergh, Rafael; Khogali, Mohammed; Manzi, Marcel; Reid, Anthony J; Ramsay, Andrew; Reeder, John C; Harries, Anthony D

2014-09-01

Between 2009 and 2012, eight operational research capacity building courses were completed in Paris (3), Luxembourg (1), India (1), Nepal (1), Kenya (1) and Fiji (1). Courses had strict milestones that were subsequently adopted by the Structured Operational Research and Training InitiaTive (SORT IT) of the World Health Organization. We report on the numbers of enrolled participants who successfully completed courses, the number of papers published and their reported effect on policy and/or practice. Retrospective cohort study including a survey. Participant selection criteria ensured that only those proposing specific programme-related and relevant operational research questions were selected. Effects on policy and/or practice were assessed in a standardised manner by two independent reviewers. Of 93 enrolled participants from 31 countries (14 in Africa, 13 in Asia, two in Latin America and two in South Pacific), 83 (89%) completed their courses. A total of 96 papers were submitted to scientific journals of which 89 (93%) were published and 88 assessed for effect on policy and practice. There was a reported effect in 65 (74%) studies including changes to programme implementation (27), adaptation of monitoring tools (24) and changes to existing guidelines (20). Three quarters of published operational research studies from these structured courses had reported effects on policy and/or practice. It is important that this type of tracking becomes a standard component of operational research and research in general. © 2014 John Wiley & Sons Ltd.

Articulating current service development practices: a qualitative analysis of eleven mental health projects

PubMed Central

2014-01-01

Background The utilisation of good design practices in the development of complex health services is essential to improving quality. Healthcare organisations, however, are often seriously out of step with modern design thinking and practice. As a starting point to encourage the uptake of good design practices, it is important to understand the context of their intended use. This study aims to do that by articulating current health service development practices. Methods Eleven service development projects carried out in a large mental health service were investigated through in-depth interviews with six operation managers. The critical decision method in conjunction with diagrammatic elicitation was used to capture descriptions of these projects. Stage-gate design models were then formed to visually articulate, classify and characterise different service development practices. Results Projects were grouped into three categories according to design process patterns: new service introduction and service integration; service improvement; service closure. Three common design stages: problem exploration, idea generation and solution evaluation - were then compared across the design process patterns. Consistent across projects were a top-down, policy-driven approach to exploration, underexploited idea generation and implementation-based evaluation. Conclusions This study provides insight into where and how good design practices can contribute to the improvement of current service development practices. Specifically, the following suggestions for future service development practices are made: genuine user needs analysis for exploration; divergent thinking and innovative culture for idea generation; and fail-safe evaluation prior to implementation. Better training for managers through partnership working with design experts and researchers could be beneficial. PMID:24438471

Articulating current service development practices: a qualitative analysis of eleven mental health projects.

PubMed

Jun, Gyuchan Thomas; Morrison, Cecily; Clarkson, P John

2014-01-17

The utilisation of good design practices in the development of complex health services is essential to improving quality. Healthcare organisations, however, are often seriously out of step with modern design thinking and practice. As a starting point to encourage the uptake of good design practices, it is important to understand the context of their intended use. This study aims to do that by articulating current health service development practices. Eleven service development projects carried out in a large mental health service were investigated through in-depth interviews with six operation managers. The critical decision method in conjunction with diagrammatic elicitation was used to capture descriptions of these projects. Stage-gate design models were then formed to visually articulate, classify and characterise different service development practices. Projects were grouped into three categories according to design process patterns: new service introduction and service integration; service improvement; service closure. Three common design stages: problem exploration, idea generation and solution evaluation - were then compared across the design process patterns. Consistent across projects were a top-down, policy-driven approach to exploration, underexploited idea generation and implementation-based evaluation. This study provides insight into where and how good design practices can contribute to the improvement of current service development practices. Specifically, the following suggestions for future service development practices are made: genuine user needs analysis for exploration; divergent thinking and innovative culture for idea generation; and fail-safe evaluation prior to implementation. Better training for managers through partnership working with design experts and researchers could be beneficial.

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.

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

21 CFR 111.23 - Under this subpart C, what records must you make and keep?

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical Plant and Grounds... of the written procedures for cleaning the physical plant and for pest control. (c) You must make and...

21 CFR 111.23 - Under this subpart C, what records must you make and keep?

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical Plant and Grounds... of the written procedures for cleaning the physical plant and for pest control. (c) You must make and...

Operating Procedures to Improve Efficiencies of In vitro Exposure Systems at the Air-Liquid Interface

EPA Science Inventory

The expanding use of in vitro exposure systems for toxicity assessments has created regulatory concerns. Many of these same concerns surround the proper conduct of in vivo inhalation toxicology studies that are addressed in guidelines and Good Laboratory Practice (GLPs) regulatio...

21 CFR 111.27 - What requirements apply to the equipment and utensils that you use?

Code of Federal Regulations, 2010 CFR

2010-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Equipment and Utensils § 111... utensils that are of appropriate design, construction, and workmanship to enable them to be suitable for...

75 FR 59266 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-27

...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations... submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork...

75 FR 60463 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-30

...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for... Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax...

Developing GAP Training for Growers: Perspectives from Pennsylvania Supermarkets

ERIC Educational Resources Information Center

Tobin, Daniel; Thomson, Joan; LaBorde, Luke; Bagdonis, Jessica

2011-01-01

Major supermarket chains increasingly are requiring their produce suppliers to provide evidence of compliance with on-farm food safety standards, known as Good Agricultural Practices (GAPs). To develop a relevant GAP training curriculum that meets the needs of Pennsylvania growers, supermarkets that operate in the state were surveyed to determine…

40 CFR 265.1080 - Applicability.

Code of Federal Regulations, 2012 CFR

2012-07-01

... the requirements of paragraph (f)(2) of this section. (i) The Sistersville Plant shall install an air... all air pollution control and monitoring equipment described in paragraphs (f)(2)(i)(A) and (f)(2)(ii... is operated in a manner consistent with good air pollution control practices. (ii) Ensure that the...

40 CFR 264.1080 - Applicability.

Code of Federal Regulations, 2014 CFR

2014-07-01

... requirements of paragraph (f)(2) of this section. (i) The Sistersville Plant shall install an air pollution... all air pollution control and monitoring equipment described in paragraphs (f)(2)(i)(A) and (f)(2)(ii... is operated in a manner consistent with good air pollution control practices. (ii) Ensure that the...

40 CFR 264.1080 - Applicability.

Code of Federal Regulations, 2012 CFR

2012-07-01

... requirements of paragraph (f)(2) of this section. (i) The Sistersville Plant shall install an air pollution... all air pollution control and monitoring equipment described in paragraphs (f)(2)(i)(A) and (f)(2)(ii... is operated in a manner consistent with good air pollution control practices. (ii) Ensure that the...

40 CFR 265.1080 - Applicability.

Code of Federal Regulations, 2013 CFR

2013-07-01

... the requirements of paragraph (f)(2) of this section. (i) The Sistersville Plant shall install an air... all air pollution control and monitoring equipment described in paragraphs (f)(2)(i)(A) and (f)(2)(ii... is operated in a manner consistent with good air pollution control practices. (ii) Ensure that the...

40 CFR 264.1080 - Applicability.

Code of Federal Regulations, 2013 CFR

2013-07-01

... requirements of paragraph (f)(2) of this section. (i) The Sistersville Plant shall install an air pollution... all air pollution control and monitoring equipment described in paragraphs (f)(2)(i)(A) and (f)(2)(ii... is operated in a manner consistent with good air pollution control practices. (ii) Ensure that the...

40 CFR 265.1080 - Applicability.

Code of Federal Regulations, 2014 CFR

2014-07-01

... the requirements of paragraph (f)(2) of this section. (i) The Sistersville Plant shall install an air... all air pollution control and monitoring equipment described in paragraphs (f)(2)(i)(A) and (f)(2)(ii... is operated in a manner consistent with good air pollution control practices. (ii) Ensure that the...

75 FR 78715 - Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0605..., or Holding Operations for Dietary Supplements; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

Texas A&M Texarkana Illustrates Best Practices in PLA

ERIC Educational Resources Information Center

Delleville, Valerie

2017-01-01

Some institutions' prior learning assessment (PLA) programs are far more successful than others. As with any strategic initiative, the best-intentioned policy is only as good as the implementation, operations, and people behind it. Beyond progressing through the change management process, ensuring sustainability is critical to long-term PLA…

21 CFR 110.20 - Plant and grounds.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD Buildings and... operator shall be kept in a condition that will protect against the contamination of food. The methods for..., yards, and parking lots so that they do not constitute a source of contamination in areas where food is...

7 CFR 51.56 - Buildings and structures.

Code of Federal Regulations, 2012 CFR

2012-01-01

... waste disposal and plumbing system maintained in good repair; (d) Each room in which the product is graded or stored shall be designed and constructed as to insure operating conditions of a clean and orderly character and shall be maintained in a clean and sanitary manner; and, (e) Every practical...

7 CFR 51.56 - Buildings and structures.

Code of Federal Regulations, 2011 CFR

2011-01-01

... waste disposal and plumbing system maintained in good repair; (d) Each room in which the product is graded or stored shall be designed and constructed as to insure operating conditions of a clean and orderly character and shall be maintained in a clean and sanitary manner; and, (e) Every practical...

A Scenario-Based Process for Requirements Development: Application to Mission Operations Systems

NASA Technical Reports Server (NTRS)

Bindschadler, Duane L.; Boyles, Carole A.

2008-01-01

The notion of using operational scenarios as part of requirements development during mission formulation (Phases A & B) is widely accepted as good system engineering practice. In the context of developing a Mission Operations System (MOS), there are numerous practical challenges to translating that notion into the cost-effective development of a useful set of requirements. These challenges can include such issues as a lack of Project-level focus on operations issues, insufficient or improper flowdown of requirements, flowdown of immature or poor-quality requirements from Project level, and MOS resource constraints (personnel expertise and/or dollars). System engineering theory must be translated into a practice that provides enough structure and standards to serve as guidance, but that retains sufficient flexibility to be tailored to the needs and constraints of a particular MOS or Project. We describe a detailed, scenario-based process for requirements development. Identifying a set of attributes for high quality requirements, we show how the portions of the process address many of those attributes. We also find that the basic process steps are robust, and can be effective even in challenging Project environments.

Biosafety principles and practices for the veterinary diagnostic laboratory.

PubMed

Kozlovac, Joseph; Schmitt, Beverly

2015-01-01

Good biosafety and biocontainment programs and practices are critical components of the successful operation of any veterinary diagnostic laboratory. In this chapter we provide information and guidance on critical biosafety management program elements, facility requirements, protective equipment, and procedures necessary to ensure that the laboratory worker and the environment are adequately protected in the challenging work environment of the veterinary diagnostic laboratory in general and provide specific guidance for those laboratories employing molecular diagnostic techniques.

Operational Ethics in Coalition Warfare: Whose Ethics Will Prevail? A Philosophical/Theological Conundrum

DTIC Science & Technology

2002-05-13

the identification of reason as the prime human faculty and virtue, i.e., sense of excellence and practical wisdom as the highest good. These are the...Clothes, " National Security Studies Quarterly Spring 2000, Volume VI, Issue 2, pp. 59-71. 43 Glynis Breakwell and Keith Spacie , Pressures Facing...commander to draw upon, then what is the solution to reduce the stressors highlighted by the Breakwell and Spacie study? Can there be operational

Good Data Can Be Better Data - How Data Management Maturity Can Help Repositories Improve Operations, Data Quality, And Usability, Helping Researchers

NASA Astrophysics Data System (ADS)

Stall, S.

2015-12-01

Much earth and space science data and metadata are managed and supported by an infrastructure of repositories, ranging from large agency or instrument facilities, to institutions, to smaller repositories including labs. Scientists face many challenges in this ecosystem both on storing their data and in accessing data from others for new research. Critical for all uses is ensuring the credibility and integrity of the data and conveying that and provenance information now and in the future. Accurate information is essential for future researchers to find (or discover) the data, evaluate the data for use (content, temporal, geolocation, precision) and finally select (or discard) that data as meeting a "fit-for-purpose" criteria. We also need to optimize the effort it takes in describing the data for these determinations, which means making it efficient for the researchers who collect the data. At AGU we are developing a program aimed at helping repositories, and thereby researchers, improve data quality and data usability toward these goals. AGU has partnered with the CMMI Institute to develop their Data Management Maturity (DMM) framework within the Earth and space sciences. The CMMI DMM framework guides best practices in a range of data operations, and the application of the DMM, through an assessment, reveals how repositories and institutions can best optimize efforts to improve operations and functionality throughout the data lifecycle and elevate best practices across a variety of data management operations. Supporting processes like data operations, data governance, and data architecture are included. An assessment involves identifying accomplishment, and weaknesses compared to leading practices for data management. Broad application of the DMM can help improve quality in data and operations, and consistency across the community that will facilitate interoperability, discovery, preservation, and reuse. Good data can be better data. Consistency results in sustainability.

Design features and operational characteristics of the Langley 0.3-meter transonic cryogenic tunnel

NASA Technical Reports Server (NTRS)

Kilgore, R. A.

1976-01-01

Experience with the Langley 0.3 meter transonic cryogenic tunnel, which is fan driven, indicated that such a tunnel presents no unusual design difficulties and is simple to operate. Purging, cooldown, and warmup times were acceptable and were predicted with good accuracy. Cooling with liquid nitrogen was practical over a wide range of operating conditions at power levels required for transonic testing, and good temperature distributions were obtained by using a simple liquid nitrogen injection system. To take full advantage of the unique Reynolds number capabilities of the 0.3 meter transonic tunnel, it was designed to accommodate test sections other than the original, octagonal, three dimensional test section. A 20- by 60-cm two dimensional test section was recently installed and is being calibrated. A two dimensional test section with self-streamlining walls and a test section incorporating a magnetic suspension and balance system are being considered.

Alarms Philosophy

DOE Office of Scientific and Technical Information (OSTI.GOV)

White, Karen S; Kasemir, Kay

2009-01-01

An effective alarm system consists of a mechanism to monitor control points and generate alarm notifications, tools for operators to view, hear, acknowledge and handle alarms and a good configuration. Despite the availability of numerous fully featured tools, accelerator alarm systems continue to be disappointing to operations, frequently to the point of alarms being permanently silenced or totally ignored. This is often due to configurations that produce an excessive number of alarms or fail to communicate the required operator response. Most accelerator controls systems do a good job of monitoring specified points and generating notifications when parameters exceed predefined limits.more » In some cases, improved tools can help, but more often, poor configuration is the root cause of ineffective alarm systems. A SNS, we have invested considerable effort in generating appropriate configurations using a rigorous set of rules based on best practices in the industrial process controls community. This paper will discuss our alarm configuration philosophy and operator response to our new system.« less

[Hygiene in Urological Surgeries - Results of the Health Authority's Visit to all Urological Surgeries in Braunschweig].

PubMed

Buhr-Riehm, B; Lenz, T

2015-07-01

Following a patient complaint, the Health Department carried out a hygiene inspection of a urological practice in Braunschweig in February 2013. The topic of the complaint was that a patient assumed having acquired a resistant pathogen in the practice. In the subsequent visit, significant hygiene defects were found, particularly with regard to the processing of medical devices. This led to a decision to commit all urological practices in Braunschweig to hygiene inspections as part of a priority project. In retrospect, the hygiene surveys were justified. Deficiencies included inadequate preparation of medical products, procedures in practice inconsistent with hygiene plans, poor knowledge of hygiene procedures among assistant staff and doctors, lack of expertise of assistant staff and lack of hygiene risk awareness by doctors. Positive experiences were: open communication in a good atmosphere with the Practice managers, willingness to change, good cooperation between the Health Authority and the Labor Inspectorate and Physicians' Association. The claimed deficits were corrected by spring 2014 by the practice operators. The consulting expertise of the health authorities was made use of continuously. © Georg Thieme Verlag KG Stuttgart · New York.

13 CFR 120.826 - Basic requirements for operating a CDC.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Board of the American Institute of Certified Public Accountants (AICPA). The auditor must be independent.... The audit or review must be conducted by an independent certified public accountant who: (1) Is registered or licensed to practice as a public accountant, and is in good standing, under the laws of the...

Jar Test. Operational Control Tests for Wastewater Treatment Facilities. Instructor's Manual [and] Student Workbook.

ERIC Educational Resources Information Center

Arasmith, E. E.

The jar test is used to determine the proper chemical dosage required for good coagulation and flocculation of water. The test is commonly used in potable water, secondary effluent prior to advanced wastewater treatment, secondary clarifier influent, and sludge conditioning practice. Designed for individuals who have completed National Pollutant…

32 CFR 861.4 - DOD air transportation quality and safety requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... programs and business practices that not only ensure good service but also enhance the safety, operational...) “Equivalent to the services sought by DOD” means service offered to qualify for DOD approval must be... § 861.4 DOD air transportation quality and safety requirements. (a) General. The DOD, as a customer of...

40 CFR 90.317 - Carbon monoxide analyzer calibration.

Code of Federal Regulations, 2013 CFR

2013-07-01

... its initial use and annually thereafter, check the NDIR carbon monoxide analyzer for response to water vapor and CO2. (1) Follow good engineering practices for instrument start-up and operation. Adjust the... CO2 in N2 through water at room temperature and record analyzer response. (4) An analyzer response of...

40 CFR 90.317 - Carbon monoxide analyzer calibration.

Code of Federal Regulations, 2014 CFR

2014-07-01

... its initial use and annually thereafter, check the NDIR carbon monoxide analyzer for response to water vapor and CO2. (1) Follow good engineering practices for instrument start-up and operation. Adjust the... CO2 in N2 through water at room temperature and record analyzer response. (4) An analyzer response of...

40 CFR 90.317 - Carbon monoxide analyzer calibration.

Code of Federal Regulations, 2012 CFR

2012-07-01

... its initial use and annually thereafter, check the NDIR carbon monoxide analyzer for response to water vapor and CO2. (1) Follow good engineering practices for instrument start-up and operation. Adjust the... CO2 in N2 through water at room temperature and record analyzer response. (4) An analyzer response of...

40 CFR 90.317 - Carbon monoxide analyzer calibration.

Code of Federal Regulations, 2011 CFR

2011-07-01

... its initial use and annually thereafter, check the NDIR carbon monoxide analyzer for response to water vapor and CO2. (1) Follow good engineering practices for instrument start-up and operation. Adjust the... CO2 in N2 through water at room temperature and record analyzer response. (4) An analyzer response of...

The Influence of Technology on Communication for School Leaders: Preferences, Beliefs, and Use

ERIC Educational Resources Information Center

Young, Suzanne; Berube, William; Perry, Suzanne

2008-01-01

The value of good communication practices in schools is important to their overall operation and to how efficiently and effectively teachers and students perform (Sobel & Ornstein, 1996). The challenge of communicating as often as needed and with the appropriate method is ever present for the school administrator, in particular. Communication…

Contract Training: Avoiding the Rodney Dangerfield Syndrome by Practicing Good Internal Marketing.

ERIC Educational Resources Information Center

Kothenbeutel, Nancy; Dejardin, Conrad

1994-01-01

Suggests that, although customized training programs are often at the cutting edge of education and technology, they are not always fully integrated into the mainstream of colleges' internal operations. Discusses the role of internal marketing in promoting respect for community and adult education programs within community colleges. (MAB)

77 FR 41709 - Common Crop Insurance Regulations; Florida Citrus Fruit Crop Insurance Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-16

... their farming operation. For instance, all producers are required to submit an application and acreage... provisions published at 7 CFR part 11, or 7 CFR part 400, subpart J for determinations of good farming practices, as applicable, must be exhausted before any action against FCIC for judicial review may be...

78 FR 46249 - Common Crop Insurance Regulations; Arizona-California Citrus Crop Insurance Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-31

... part 11, or 7 CFR part 400, subpart J for determinations of good farming practices, as applicable, must... farming operation. For instance, all producers are required to submit an application and acreage report to... this change will allow policyholders to make farming decisions based on the best interest of their...

Good manufacturing practice and viral safety.

PubMed

Kerner, B

1995-07-01

The concept of virus inactivation during the manufacture of blood products raises questions about possible recontamination of the product by the environment. A strict regime of good manufacturing practice (GMP) is mandatory. The guidelines originally issued by the World Health Organization (WHO), and now law in most countries, are an excellent basis for the operation of a production plant. The following elements of GMP require special concern: (i) All functions shall be defined in a clear organization chart. (ii) Personnel shall be appropriately trained for the job and to perfect hygiene. (iii) Buildings and facilities, as well as supply systems, shall exclude the possibility of recontamination of already virus-inactivated materials. (iv) Equipment shall be easy to clean and fully sterilizable. (v) Production shall follow appropriate written procedures. (vi) The Quality Control Organization shall monitor the process by in-process controls and review the records for possible deviations. All GMP issues are coordinated by a Quality Assurance Organization that also reviews the overall performance of the operation. The maintenance of viral safety of the products basically depends upon the full commitment of all bodies involved to proper and non-negotiable GMP.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sklenka, L.; Rataj, J.; Frybort, J.

Research reactors play an important role in providing key personnel of nuclear power plants a hands-on experience from operation and experiments at nuclear facilities. Training of NPP (Nuclear Power Plant) staff is usually deeply theoretical with an extensive utilisation of simulators and computer visualisation. But a direct sensing of the reactor response to various actions can only improve the personnel awareness of important aspects of reactor operation. Training Reactor VR-1 and its utilization for training of NPP operators and other professionals from Czech Republic and Slovakia is described. Typical experimental exercises and good practices in organization of a training programmore » are demonstrated. (authors)« less

Food safety knowledge, attitude, and practice toward compliance with abattoir laws among the abattoir workers in Malaysia.

PubMed

Abdullahi, Auwalu; Hassan, Azmi; Kadarman, Norizhar; Saleh, Ahmadu; Baraya, Yusha'u Shu'aibu; Lua, Pei Lin

2016-01-01

Foodborne diseases are common in the developing countries due to the predominant poor food handling and sanitation practices, particularly as a result of inadequate food safety laws, weak regulatory structures, and inadequate funding as well as a lack of appropriate education for food-handlers. The most frequently involved foods in disease outbreaks are of animal origin. However, in spite of the adequate legislation and laws governing the abattoir operation in Malaysia, compliance with food safety requirements during meat processing and waste disposal is inadequate. Therefore, the present study was designed to assess the food safety knowledge, attitude, and practice toward compliance with abattoir laws among the workers in Terengganu, Malaysia. A cross-sectional survey was conducted using simple random sampling technique in the six districts of Terengganu: two districts were used for the pilot study and the remaining four were used for the main study. One hundred sixty-five abattoir workers from the selected districts were interviewed using a structured questionnaire. The mean and standard deviation of knowledge, attitude, and practice scores of the workers were 6.02 and 1.954, 45.16 and 4.496, and 18.03 and 3.186, respectively. The majority of the workers (38.8%) had a low level of knowledge and 91.7% had a positive attitude, while 77.7% had a good practice of compliance. Sex had a significant association with the level of knowledge (P<0.001) and practice (P=0.044) among the workers. The females had a higher level of knowledge than the males, while the males had a better practice of compliance than females. Similarly, knowledge also had a significant (P=0.009) association with the level of practice toward compliance with abattoir laws among the workers. The abattoir workers had a positive attitude and good practice, but a low level of knowledge toward compliance with the abattoir laws. Therefore, public awareness, workshops, and seminars relevant to the abattoir operations should be encouraged.

System level airworthiness tool: A comprehensive approach to small unmanned aircraft system airworthiness

NASA Astrophysics Data System (ADS)

Burke, David A.

One of the pillars of aviation safety is assuring sound engineering practices through airworthiness certification. As Unmanned Aircraft Systems (UAS) grow in popularity, the need for airworthiness standards and verification methods tailored for UAS becomes critical. While airworthiness practices for large UAS may be similar to manned aircraft, it is clear that small UAS require a paradigm shift from the airworthiness practices of manned aircraft. Although small in comparison to manned aircraft these aircraft are not merely remote controlled toys. Small UAS may be complex aircraft flying in the National Airspace System (NAS) over populated areas for extended durations and beyond line of sight of the operators. A comprehensive systems engineering framework for certifying small UAS at the system level is needed. This work presents a point based tool that evaluates small UAS by rewarding good engineering practices in design, analysis, and testing. The airworthiness requirements scale with vehicle size and operational area, while allowing flexibility for new technologies and unique configurations.

A practical guide to the design and construction of a single wire beverage antenna

NASA Astrophysics Data System (ADS)

Spong, H. L.

1980-09-01

Theoretical results are presented which show the performance likely to result from using differing antenna heights, lengths and wire sizes and from operating with different ground conductivities. These studies were undertaken to provide practical advice for constructors and operators. Design parameters can be easily obtained with the aid of computer programs and an antenna can be rapidly constructed from readily available materials. Directivity can be increased by adding more elements, either in parallel or on a radial basis. A particular performance can be achieved with great latitude in the parameters. Good low angle performance can be achieved without large ground screens. A directional array can be made by switching between a number of elements set up on different bearings.

Establishing powder-handling workflow practices and standard operating procedures: compounding pharmacy and safety.

PubMed

Prince, Bryan; Lundevall, Jeremy

2014-01-01

This is an ongoing discussion and analysis of powder-handling safety in the compounding pharmacy laboratory that started in the November/December 2013 issue of the International Journal of Pharmaceutical Compounding. In the previous technical article, we established that most chemical powders handled during compounding procedures have an established occupational exposure limits and that powders are micronized during manipulation. All micronized powders handled on an open bench create health hazards to the technicians and create a potential for cross-contamination to the lab environment. Proper identification of the chemical hazard and established standard operating procedures in direct correlation to Good Lab Practices when working inside a powder hood will positively improve the compounding pharmacy's work environment.

Reduction of Conflicts in Mining Development Using "Good Neighbor Agreements"

NASA Astrophysics Data System (ADS)

Masaitis, A.

2013-05-01

New environmental and social challenges for the mining industry in both developed and developing countries show the obvious need to implement "responsible" mining practices that include improved community involvement. Good Neighbor Agreements (GNA's) are a relatively new mechanism for improving communication and trust between a mining company and the community. The focus of a GNA will be to provide a written and enforceable agreement, negotiated between the concerned public and the respective mining company to respond to concerns from the public, and also provide a mechanism for conflict resolution, when there is mutual benefit to maintain a working relationship. Development of GNA's, a recently evolving process that promotes environmentally sound relationships between mines and the surrounding communities. Modify and apply the resulting GNA formulas to the developing countries and countries with transitional economies. This is particularly important for countries that have poorly functioning regulatory systems that cannot guarantee a healthy and safe environment for the communities. The fundamental questions addressed by this research. 1. This is a three-year research project started in August 2012 at the University of Nevada, Reno (UNR) to develop a Good Neighbor Agreements standards as well as to investigate the details of mine development. 2. Identify spheres of possible cooperation between mining companies, government organizations, and the Non-Governmental Organizations (NGO's). Use this cooperation to develop international standards for the GNA, to promote exchange of environmental information, and exchange of successful environmental, health, and safety practices between mining operations from different countries. Discussion: The Good Neighbor Agreement currently evolving will address the following: 1. 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. 2. Increase the diversity of people benefiting from the results of this research by providing standards that could be adopted in developing countries. The goal of the GNA is to have open access for the public to the safety, health, and environmental information pertaining to the mining operation, as well as to educate the local communities about safe and sustainable mining practices that promote mutual acknowledgment of the need to build a relationship amenable to each other's needs. Frequent conflicts between mining companies and surrounding communities lead to work disruptions or even mine closures and show the necessity of a less confrontational approach to environmental and social justice. Because of the higher quality environmental standards already in place, this new approach perhaps should first be established in developed countries and then applied to other countries with less developed economies. The Good Neighbor Agreement is a unique way to provide the benefits for the both mining operations and local community to provide a mechanism for development of trust and communication that offer the potential to protect both mining and community interests, and can possibly reduce conflicts in resource development projects.

Halal Logistics Implementation in Malaysia: A Practical View

NASA Astrophysics Data System (ADS)

Sham, Rohana; Zuraidah Rasi, Raja; Abdamia, Noranita; Mohamed, Suhana; Thahira Bibi, TKM

2017-08-01

Concept of halal is not only acceptable world wide by the Muslim society but also to the non Muslim. However, the implementing of halal logistics in daily operation experience a few difficulties especially on the implementation part. Although there are many academic research paper that highlight the issue of halal logistics and the critical success factor, until today, halal logistics in Malaysia is still experiencing a hiccup. This paper try to highlight a few simple ways of implementation of halal logistics that could enhance the total implementation concept at the very least cost to create benefit to all society. The Paper deals with a few aspect of possible implementation and practice to facilitate the halal logistics approach in daily operation. The main objective is to look at the possible method of implementation and critical success factors towards the implementation of halal logistics operation in daily goods movement in Malaysia.

77 FR 21795 - Notice of Submission of Proposed Information Collection to OMB Public Housing Agency Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork... comprehensive guide to PHA policies, programs, operations, and strategies for meeting local housing needs and... proposals. It is expected that Qualified PHAs, as a matter of good business practice, continue to keep their...

75 FR 15777 - Common Crop Insurance Regulations, Basic Provisions; and Various Crop Insurance Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-30

..., according to the recent Good Farming Practices Bulletin, there is a need in the field for unbiased and... farming operation. For instance, all producers are required to submit an application and acreage report to... excessive loss (bad farming, fraud, or bad luck), those policies should pay a recapture premium. The...

77 FR 22467 - Common Crop Insurance Regulations; Fresh Market Tomato (Dollar Plan) Crop Provisions

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-16

... farming operation. For instance, all producers are required to submit an application and acreage report to... part 11, or 7 CFR part 400, subpart J for the informal administrative review process of good farming practices as applicable, must be exhausted before any action against FCIC for judicial review may be brought...

Item Pool Design for an Operational Variable-Length Computerized Adaptive Test

ERIC Educational Resources Information Center

He, Wei; Reckase, Mark D.

2014-01-01

For computerized adaptive tests (CATs) to work well, they must have an item pool with sufficient numbers of good quality items. Many researchers have pointed out that, in developing item pools for CATs, not only is the item pool size important but also the distribution of item parameters and practical considerations such as content distribution…

Using MSD prevention for cultural change in mining: Queensland Government/Anglo Coal Industry partnership.

PubMed

Tilbury, Trudy; Sanderson, Liz

2012-01-01

Queensland Mining has a strong focus on safety performance, but risk management of health, including Musculoskeletal Disorders (MSDs) continues to have a lower priority. The reliance on individual screening of workers and lower level approaches such as manual handling training is part of the coal mining 'culture'. Initiatives such as the New South Wales and Queensland Mining joint project to develop good practice guidance for mining has allowed for a more consistent message on participatory ergonomics and prevention of MSD. An evidence based practice approach, including the introduction of participatory ergonomics and safe design principles, was proposed to Anglo American Coal operations in Queensland. The project consisted of a skills analysis of current health personnel, design of a facilitated participatory ergonomics training program, site visits to identify good practice and champions, and a graduated mentoring program for health personnel. Early results demonstrate a number of sites are benefiting from site taskforces with a focus on positive performance outcomes.

Avoiding Human Error in Mission Operations: Cassini Flight Experience

NASA Technical Reports Server (NTRS)

Burk, Thomas A.

2012-01-01

Operating spacecraft is a never-ending challenge and the risk of human error is ever- present. Many missions have been significantly affected by human error on the part of ground controllers. The Cassini mission at Saturn has not been immune to human error, but Cassini operations engineers use tools and follow processes that find and correct most human errors before they reach the spacecraft. What is needed are skilled engineers with good technical knowledge, good interpersonal communications, quality ground software, regular peer reviews, up-to-date procedures, as well as careful attention to detail and the discipline to test and verify all commands that will be sent to the spacecraft. Two areas of special concern are changes to flight software and response to in-flight anomalies. The Cassini team has a lot of practical experience in all these areas and they have found that well-trained engineers with good tools who follow clear procedures can catch most errors before they get into command sequences to be sent to the spacecraft. Finally, having a robust and fault-tolerant spacecraft that allows ground controllers excellent visibility of its condition is the most important way to ensure human error does not compromise the mission.

Do we need animal hands-on courses for transplantation surgery?

PubMed

Golriz, Mohammad; Hafezi, Mohammadreza; Garoussi, Camelia; Fard, Nassim; Arvin, Jalal; Fonouni, Hamidreza; Nickkholgh, Arash; Kulu, Yakob; Frongia, Giovani; Schemmer, Peter; Mehrabi, Arianeb

2013-01-01

Transplantation surgery requires many years of training. This study evaluates and presents the results of our recent four-yr animal hands-on courses of transplantation surgery on participants' training. Since 2008, five two-d hands-on courses of transplantation surgery were performed on swine models at our department. Sixty-one participants were asked to answer three questionnaires (pre-course, immediate post-course, subsequent post-course). The questions pertained to their past education, expectations, and evaluation of our courses, as well as our course's effectiveness in advancing their surgical abilities. The results were analyzed, compared and are presented herein. On average, 1.8 multiorgan procurements, 2.3 kidney, 1.5 liver, and 0.7 pancreas transplantations were performed by each participant. 41.7% of participants considered their previous practical training only satisfactory; 85% hoped for more opportunities to practice surgery; 73.3% evaluated our courses as very good; and 95.8% believed that our courses had fulfilled their expectations. 66% found the effectiveness of our course in advancing their surgical abilities very good; 30% good, and 4% satisfactory. Animal hands-on courses of transplantation surgery are one of the best options to learn and practice different operations and techniques in a near to clinical simulated model. Regular participation in such courses with a focus on practical issues can provide optimal opportunities for trainees with the advantage of direct mentoring and feedback. © 2013 John Wiley & Sons A/S.

Best practice guidelines for the operation of a donor human milk bank in an Australian NICU.

PubMed

Hartmann, B T; Pang, W W; Keil, A D; Hartmann, P E; Simmer, K

2007-10-01

Until the establishment of the PREM Bank (Perron Rotary Express Milk Bank) donor human milk banking had not occurred in Australia for the past 20 years. In re-establishing donor human milk banking in Australia, the focus of the PREM Bank has been to develop a formal and consistent approach to safety and quality in processing during the operation of the human milk bank. There is currently no existing legislation in Australia that specifically regulates the operation of donor human milk banks. For this reason the PREM Bank has utilised existing and internationally recognised management practices for managing hazards during food production. These tools (specifically HACCP) have been used to guide the development of Standard Operating Procedures and Good Manufacturing Practice for the screening of donors and processing of donor human milk. Donor screening procedures are consistent with those recommended by other human milk banks operating internationally, and also consistent with the requirements for blood and tissue donation in Australia. Controlled documentation and record keep requirements have also been developed that allow complete traceability from individual donation to individual feed dispensed to recipient and maintain a record of all processing and storage conditions. These operational requirements have been developed to reduce any risk associated with feeding pasteurised donor human milk to hospitalised preterm or ill infants to acceptable levels.

Oral health knowledge and practices of dentists practicing in a teaching hospital in Nigeria.

PubMed

Jegede, Akinlolu Tolulope; Oyedele, Titus Ayodeji; Sodipo, Babasola Olufemi; Folayan, Morenike Oluwatoyin

2016-01-01

To assess the oral health practices and knowledge of practicing dentists at a tertiary health institution in Nigeria, and the possible association of age and sex with caries prevention practices. A cross-sectional study was conducted. All practicing dentists in the institution were eligible to participate in the study. A questionnaire that assessed oral health practices and knowledge was administered. Respondents were expected to select the most appropriate responses that reflected their knowledge of oral health practices and caries prevention practices. Questions included assessment of knowledge and practice of tooth brushing, flossing, refined carbohydrate intake, and dental service utilization. Participants' responses were scored and dichotomized to poor and good knowledge, and poor and good practices, using the median scores. Bivariate analysis was conducted to identify factors associated with good and poor oral health practices, and good and poor knowledge. Fifty-two eligible study participants were accessible at the time of questionnaire administration. Only 46 respondents returned the filled questionnaire giving a response rate of 88.5%. The age of respondents ranged between 25 and 48 years. The majority of respondents had good oral health practices (65.2%) and good oral health knowledge (85%). However, few respondents had good caries prevention practices: 39.2% brushed at least twice daily, 45.7% took refined carbohydrate less than once daily, 36.9% used dental floss at least once daily, and 60.9% undertook preventive dental care. The correlation between the dentists' oral health knowledge score and oral health practices score was insignificant (0.90; P = 0.55). A large number of dentists practicing in the tertiary hospital had good oral health practices and good oral health knowledge. However, the proportion of dentists with good caries prevention practices was low.

Evaluating operational vacuum for landfill biogas extraction.

PubMed

Fabbricino, Massimiliano

2007-01-01

This manuscript proposes a practical methodology for estimating the operational vacuum for landfill biogas extraction from municipal landfills. The procedure is based on two sub-models which simulate landfill gas production from organic waste decomposition and distribution of gas pressure and gas movement induced by suction at a blower station. The two models are coupled in a single mass balance equation, obtaining a relationship between the operational vacuum and the amount of landfill gas that can be extracted from an assigned system of vertical wells. To better illustrate the procedure, it is applied to a case study, where a good agreement between simulated and measured data, within +/- 30%, is obtained.

A review of the International Atomic Energy Agency (IAEA) international standards for tissue banks.

PubMed

Morales Pedraza, Jorge; Lobo Gajiwala, Astrid; Martinez Pardo, María Esther

2012-03-01

The IAEA International Standards for Tissue Banks published in 2003 were based on the Standards then currently in use in the USA and the European Union, among others, and reflect the best practices associated with the operation of a tissue bank. They cover legal, ethical and regulatory controls as well as requirements and procedures from donor selection and tissue retrieval to processing and distribution of finished tissue for clinical use. The application of these standards allows tissue banks to operate with the current good tissue practice, thereby providing grafts of high quality that satisfy the national and international demand for safe and biologically useful grafts. The objective of this article is to review the IAEA Standards and recommend new topics that could improve the current version.

National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities.

PubMed

Ricordi, Camillo; Goldstein, Julia S; Balamurugan, A N; Szot, Gregory L; Kin, Tatsuya; Liu, Chengyang; Czarniecki, Christine W; Barbaro, Barbara; Bridges, Nancy D; Cano, Jose; Clarke, William R; Eggerman, Thomas L; Hunsicker, Lawrence G; Kaufman, Dixon B; Khan, Aisha; Lafontant, David-Erick; Linetsky, Elina; Luo, Xunrong; Markmann, James F; Naji, Ali; Korsgren, Olle; Oberholzer, Jose; Turgeon, Nicole A; Brandhorst, Daniel; Chen, Xiaojuan; Friberg, Andrew S; Lei, Ji; Wang, Ling-Jia; Wilhelm, Joshua J; Willits, Jamie; Zhang, Xiaomin; Hering, Bernhard J; Posselt, Andrew M; Stock, Peter G; Shapiro, A M James; Chen, Xiaojuan

2016-11-01

Eight manufacturing facilities participating in the National Institutes of Health-sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed. © 2016 by the American Diabetes Association.

National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities

PubMed Central

Balamurugan, A.N.; Szot, Gregory L.; Kin, Tatsuya; Liu, Chengyang; Czarniecki, Christine W.; Barbaro, Barbara; Bridges, Nancy D.; Cano, Jose; Clarke, William R.; Eggerman, Thomas L.; Hunsicker, Lawrence G.; Kaufman, Dixon B.; Khan, Aisha; Lafontant, David-Erick; Linetsky, Elina; Luo, Xunrong; Markmann, James F.; Naji, Ali; Korsgren, Olle; Oberholzer, Jose; Turgeon, Nicole A.; Brandhorst, Daniel; Chen, Xiaojuan; Friberg, Andrew S.; Lei, Ji; Wang, Ling-jia; Wilhelm, Joshua J.; Willits, Jamie; Zhang, Xiaomin; Hering, Bernhard J.; Posselt, Andrew M.; Stock, Peter G.; Shapiro, A.M. James

2016-01-01

Eight manufacturing facilities participating in the National Institutes of Health–sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed. PMID:27465220

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 and...

Exploration and practice of the cultivation of optoelectronic innovative talents based on the Students Innovation Training Program

NASA Astrophysics Data System (ADS)

Lei, Bing; Liu, Wei; Shi, Jianhua; Yao, Tianfu; Wang, Wei; Hu, Haojun

2017-08-01

The Students Innovation Training Program (SITP) has become an effective method to impel the teaching reform and improve undergraduate's innovative practical ability in Chinese colleges and universities, which is quite helpful for students to understand the social requirement, to grasp the basic means of scientific research and to improve their innovative practical ability and team work spirit. In this paper, three problems have been analyzed and discussed based on our organizing and instructing experience of SITP in recent years. Firstly, the SITP is a synthetically training project, and it is quite suitable to cultivate the students' innovative practical ability. Because SITP is similar to the real scientific research activity, and both of them include the steps of project application, solution design, research implementation and project summary etc. By making great efforts to these basic training steps, the undergraduates' innovative practical ability has been improved systemically. Secondly, a new talents cultivation system has been constructed based on SITP by integrating the subject competitions, graduation design and other conventional training activities, which is quite good to improve the training quality and decrease the total training class hours. Thirdly, a series of long-term effective operation and management guidelines have been established to ensure the SITP work normally, including doing a good job of project evaluation, setting up a reward and punishment system and creating a good atmosphere for innovation. In conclusion, great efforts have been made to enhance undergraduates' innovative ability, and the research results will provide useful reference for improving the training effects and reforming talents cultivating mode further.

Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force

PubMed Central

Powers, John H.; Patrick, Donald L.; Walton, Marc K.; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B.

2017-01-01

A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients’ health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient’s health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of ClinRO assessments used as end points in clinical trials. Applying good measurement practices to ClinRO assessment development and evaluation will lead to more efficient and accurate measurement of treatment effects. This is important beyond regulatory approval in that it provides evidence for the uptake of new interventions into clinical practice and provides justification to payers for reimbursement on the basis of the clearly demonstrated added value of the new intervention. PMID:28212963

Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.

PubMed

Powers, John H; Patrick, Donald L; Walton, Marc K; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B

2017-01-01

A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of ClinRO assessments used as end points in clinical trials. Applying good measurement practices to ClinRO assessment development and evaluation will lead to more efficient and accurate measurement of treatment effects. This is important beyond regulatory approval in that it provides evidence for the uptake of new interventions into clinical practice and provides justification to payers for reimbursement on the basis of the clearly demonstrated added value of the new intervention. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Secondary Containment Design for the LLNL B801 Diala Oil Tank

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mertesdorf, E.

2016-12-14

Design is to add an extension to the secondary containment of tank T1-A3 at building 801. Piping from the inner tank penetrates the secondary containment tank below the liquid level of the primary tank. To meet Oil Pollution Prevention Regulation 40 CFR 120.7 the single wall piping needs to be provided with secondary containment. Steel Tank Institute (STI) conference publication states: §112.3(d)(1)(iii) –SPCC Plan requirements- Systems shall be designed in accordance with good engineering practice, including consideration of applicable industry standards and that procedures for required inspections and testing have been established. Section 112.7(a)(2) allows for deviations from specific rulemore » requirements, provided the Owner/operator responsible to select, document and implement alternate measure and a PE certifies the SPCC Plan in accordance with good engineering practices, including consideration of industry standards« less

Guidelines on Good Clinical Laboratory Practice

PubMed Central

Ezzelle, J.; Rodriguez-Chavez, I. R.; Darden, J. M.; Stirewalt, M.; Kunwar, N.; Hitchcock, R.; Walter, T.; D’Souza, M. P.

2008-01-01

A set of Good Clinical Laboratory Practice (GCLP) standards that embraces both the research and clinical aspects of GLP were developed utilizing a variety of collected regulatory and guidance material. We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. These GCLP standards provide guidance on implementing GLP requirements that are critical for laboratory operations, such as performance of protocol-mandated safety assays, peripheral blood mononuclear cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials. The expectation is that compliance with the GCLP standards, monitored annually by external audits, will allow research and development laboratories to maintain data integrity and to provide immunogenicity, safety, and product efficacy data that is repeatable, reliable, auditable and that can be easily reconstructed in a research setting. PMID:18037599

Electronic business model for small- and medium-sized manufacturing enterprises (SME): a case study

NASA Astrophysics Data System (ADS)

Yuen, Karina; Chung, Walter W.

2001-10-01

This paper identifies three essential factors (information infrastructure, executive information system and a new manufacturing paradigm) that are used to support the development of a new business model for competitiveness. They facilitate changes in organization structure in support of business transformation. A SME can source a good manufacturing practice using a model of academic-university collaboration to gain competitive advantage in the e-business world. The collaboration facilitates the change agents to use information systems development as a vehicle to increase the capability of executives in using information and knowledge management to gain higher responsiveness and customer satisfaction. The case company is used to illustrate the application of a web-based executive information system to interface internal communications with external operation. It explains where a good manufacturing practice may be re-applied by other SMEs to acquire skills as a learning organization grows in an extended enterprise setting.

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

...] Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission... entitled ``PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.'' FDA has... consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency...

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 Act...

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 regulations...

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, inclusive...

Practices in security and confidentiality of HIV/AIDS patients' information: A national survey among staff at HIV outpatient clinics in Vietnam.

PubMed

Khac Hai, Nguyen; Lawpoolsri, Saranath; Jittamala, Podjanee; Thi Thu Huong, Phan; Kaewkungwal, Jaranit

2017-01-01

Breach of confidentiality or invasion of privacy from the collection and use of medical records, particularly those of patients with HIV/AIDS or other diseases sensitive to stigmatization, should be prevented by all related stakeholders in healthcare settings. The main focus of this study was to assess practices regarding security and confidentiality of HIV-related information among staff at HIV outpatient clinics (HIV-OPCs) in Vietnam. A descriptive cross-sectional study was conducted at all 312 HIV-OPCs across the country using an online survey technique. In general, the staff practices for securing and protecting patient information were at acceptable levels. Most staff had proper measures and practices for maintaining data security; however, the protection of patient confidentiality, particularly for data access, sharing, and transfer still required improvement. Most HIV-OPC staff had good or moderate knowledge and positive perceptions towards security and confidentiality issues. Staff who were not trained in the practice of security measures differed significantly from those who were trained (OR: 3.74; 95%CI: 1.44-9.67); staff needing improved knowledge levels differed significantly from those with good (OR: 5.20; 95%CI: 2.39-11.32) and moderate knowledge levels (OR: 5.10; 95%CI: 2.36-11.00); and staff needing improved perception levels differed significantly from those with good (i.e., with 100% proper practices) and moderate perception levels (OR: 5.67; 95%CI: 2.93-10.95). Staff who were not trained in the protection of data confidentiality differed significantly from those who were trained (OR: 2.18; 95%CI: 1.29-3.65). Training is an important factor to help raise the levels of proper practices regarding confidentiality and security, to improve knowledge and raise awareness about change among staff. The operation and management of HIV treatment and care in Vietnam are currently transitioning from separate healthcare clinics (HIV-OPC) into units integrated into general hospitals/healthcare facilities. The findings of this study highlight topics that could be used for improving management and operation of information system and revising guidelines and regulations on protection measures/strategies for data security and confidentiality of HIV/AIDS patients by Vietnam health authorities or other countries facing similar situations. Secure infrastructure and secure measures for data access and use are very important, worthwhile investments. The provision of continuous training and active enforcement and monitoring of the practices of healthcare personnel might lead to an improved understanding and acknowledegement of the importance of national policies/guidelines regarding HIV-related patient information.

Food safety knowledge, attitude, and practice toward compliance with abattoir laws among the abattoir workers in Malaysia

PubMed Central

Abdullahi, Auwalu; Hassan, Azmi; Kadarman, Norizhar; Saleh, Ahmadu; Baraya, Yusha’u Shu’aibu; Lua, Pei Lin

2016-01-01

Purpose Foodborne diseases are common in the developing countries due to the predominant poor food handling and sanitation practices, particularly as a result of inadequate food safety laws, weak regulatory structures, and inadequate funding as well as a lack of appropriate education for food-handlers. The most frequently involved foods in disease outbreaks are of animal origin. However, in spite of the adequate legislation and laws governing the abattoir operation in Malaysia, compliance with food safety requirements during meat processing and waste disposal is inadequate. Therefore, the present study was designed to assess the food safety knowledge, attitude, and practice toward compliance with abattoir laws among the workers in Terengganu, Malaysia. Materials and methods A cross-sectional survey was conducted using simple random sampling technique in the six districts of Terengganu: two districts were used for the pilot study and the remaining four were used for the main study. One hundred sixty-five abattoir workers from the selected districts were interviewed using a structured questionnaire. Results The mean and standard deviation of knowledge, attitude, and practice scores of the workers were 6.02 and 1.954, 45.16 and 4.496, and 18.03 and 3.186, respectively. The majority of the workers (38.8%) had a low level of knowledge and 91.7% had a positive attitude, while 77.7% had a good practice of compliance. Sex had a significant association with the level of knowledge (P<0.001) and practice (P=0.044) among the workers. The females had a higher level of knowledge than the males, while the males had a better practice of compliance than females. Similarly, knowledge also had a significant (P=0.009) association with the level of practice toward compliance with abattoir laws among the workers. Conclusion The abattoir workers had a positive attitude and good practice, but a low level of knowledge toward compliance with the abattoir laws. Therefore, public awareness, workshops, and seminars relevant to the abattoir operations should be encouraged. PMID:27110137

The quality of operative note taking: an audit using the Royal College of Surgeons Guidelines as the gold standard.

PubMed

Shayah, A; Agada, F O; Gunasekaran, S; Jassar, P; England, R J A

2007-04-01

To assess the quality of operative note keeping and compare the results with the Royal College of Surgeons (RCS) of England guidelines 'Good Surgical Practice' as the gold standard. ENT Department at Hull Royal Infirmary, University Hospital. A hundred consecutive operative notes were selected between November 2005 and January 2006. The documentation of the operative notes in each case was compared with the RCS of England guidelines. All surgeons were made aware of the results of the first cycle and the guidelines were made available in all ENT theatres in the form of a printed aide-memoir. A second audit cycle was then carried out prospectively between April and June 2006. The results demonstrated a change in practice in key areas. The 1st cycle results showed the documentation of patient identification (94%), name of surgeon (98%) and clearly written postoperative instructions (94%). However, surgeons performed suboptimally at recording the name of assistant (82%), operative diagnosis (46%), the incision type (87%) and the type of wound closure (83%). After introducing the aide-memoir, the second cycle demonstrated a change in practice with 100% documentation in most of the assessed parameters except that the time of surgery and the type of surgery (emergency or elective) were not adequately recorded. We recommend that all surgical departments should have the RCS guidelines as an aide-memoir in theatres to enhance the quality and standardise operative note recording.

Challenges in Preparing Veterinarians for Global Animal Health: Understanding the Public Sector.

PubMed

Hollier, Paul J; Quinn, Kaylee A; Brown, Corrie C

Understanding of global systems is essential for veterinarians seeking to work in realms outside of their national domain. In the global system, emphasis remains on the public sector, and the current curricular emphasis in developed countries is on private clinical practice for the domestic employment market. There is a resulting lack of competency at graduation for effective engagement internationally. The World Organisation for Animal Health (OIE) has created standards for public sector operations in animal health, which must be functional to allow for sustainable development. This public sector, known as the Veterinary Services, or VS, serves to control public good diseases, and once effectively built and fully operational, allows for the evolution of a functional private sector, focused on private good diseases. Until the VS is fully functional, support of private good services is non-sustainable and any efforts delivered are not long lasting. As new graduates opt for careers working in the international development sector, it is essential that they understand the OIE guidelines to help support continuing improvement. Developing global veterinarians by inserting content into the veterinary curriculum on how public systems can operate effectively could markedly increase the potential of our professional contributions globally, and particularly in the areas most in need.

Creating Impact with Operations Research in Health: Making Room for Practice in Academia

PubMed Central

Brandeau, Margaret L.

2015-01-01

Operations research (OR)-based analyses have the potential to improve decision making for many important, real-world health care problems. However, junior scholars often avoid working on practical applications in health because promotion and tenure processes tend to value theoretical studies more highly than applied studies. This paper discusses the author's experiences in using OR to inform and influence decisions in health and provides a blueprint for junior researchers who wish to find success by taking a similar path. This involves selecting good problems to study, forming productive collaborations with domain experts, developing appropriate models, identifying the most salient results from an analysis, and effectively disseminating findings to decision makers. The paper then suggests how journals, funding agencies, and senior academics can encourage such work by taking a broader and more informed view of the potential role and contributions of OR to solving health care problems. Making room in academia for the application of OR in health follows in the tradition begun by the founders of operations research: to work on important real-world problems where operations research can contribute to better decision making. PMID:26003321

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 for...

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 set...

[Biosafety in laboratories concerning exposure to biological agents].

PubMed

Vonesch, N; Tomao, P; Di Renzi, S; Vita, S; Signorini, S

2006-01-01

Laboratory workers are exposed to a variety of potential occupational health hazards including those deriving from infectious materials and cultures, radiations, toxic and flammable chemicals, as well as mechanical and electrical hazard. Although all of them are significant, this paper will focus on biological hazards present in clinical and research laboratories. In fact, in spite of numerous publications, guidelines and regulations, laboratory workers are still subject to infections acquired in the course of their researches. This paper describes some aspects that include good microbiological practices (GMPs), appropriate containment equipment, practices and operational procedures to minimize workers' risk of injury or illness.

Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines.

PubMed

Ravinetto, Raffaella; De Nys, Katelijne; Boelaert, Marleen; Diro, Ermias; Meintjes, Graeme; Adoke, Yeka; Tagbor, Harry; Casteels, Minne

2015-12-30

Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period. One organisation (the sponsor) designs and carries out the trial in collaboration with research partners, and is ultimately responsible for the trial's scientific, ethical, regulatory and legal aspects, while another organization, generally in the North (the funder), provides the external funding and sets funding conditions. Even if external funding mechanisms are key for most non-commercial research, the dependence on an external funder's policies may heavily influence the choices of a sponsor. In addition, the competition for accessing the available external funds is great, and non-commercial sponsors may not be in a position to discuss or refuse standard conditions set by a funder. To see whether the current definitions adequately address the intricacies of sponsorship in externally-funded trials, we looked at how a "sponsor" of clinical trials is defined in selected international guidelines, with particular focus on international Good Clinical Practices codes, and in selected European and African regulations/legislations. Our limited analysis suggests that the sponsors definition from the 1995 WHO Good Clinical Practices code has been integrated as such into many legislations, guidelines and regulations, and that it is not adequate to cover today's reality of funding arrangements in global health, where the legal responsibility and the funding source are de facto split. In agreement with other groups, we suggest that the international Good Clinical Practices codes should be updated to reflect the reality of non-commercial clinical research. In particular, they should explicitly include the distinction between commercial and non-commercial sponsors, and provide guidance to non-commercial sponsors for negotiating with external funding agencies and other research counterparts. Non-commercial sponsors of clinical trials should surely invest in the development of adequate legal, administrative and management skills. By acknowledging their role and specificities, and by providing them with adapted guidance, the international Good Clinical Practices codes would provide valuable guidance and support to non-commercial clinical research, whose relevance for global health is increasingly evident.

Supporting good practice in the provision of services to people with comorbid mental health and alcohol and other drug problems in Australia: describing key elements of good service models.

PubMed

Merkes, Monika; Lewis, Virginia; Canaway, Rachel

2010-12-03

The co-occurrence of mental illness and substance use problems (referred to as "comorbidity" in this paper) is common, and is often reported by service providers as the expectation rather than the exception. Despite this, many different treatment service models are being used in the alcohol and other drugs (AOD) and mental health (MH) sectors to treat this complex client group. While there is abundant literature in the area of comorbidity treatment, no agreed overarching framework to describe the range of service delivery models is apparent internationally or at the national level. The aims of the current research were to identify and describe elements of good practice in current service models of treatment of comorbidity in Australia. The focus of the research was on models of service delivery. The research did not aim to measure the client outcomes achieved by individual treatment services, but sought to identify elements of good practice in services. Australian treatment services were identified to take part in the study through a process of expert consultation. The intent was to look for similarities in the delivery models being implemented across a diverse set of services that were perceived to be providing good quality treatment for people with comorbidity problems. A survey was designed based on a concept map of service delivery devised from a literature review. Seventeen Australian treatment services participated in the survey, which explored the context in which services operate, inputs such as organisational philosophy and service structure, policies and procedures that guide the way in which treatment is delivered by the service, practices that reflect the way treatment is provided to clients, and client impacts. The treatment of people with comorbidity of mental health and substance use disorders presents complex problems that require strong but flexible service models. While the treatment services included in this study reflected the diversity of settings and approaches described in the literature, the research found that they shared a range of common characteristics. These referred to: service linkages; workforce; policies, procedures and practices; and treatment.

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.

Emerging Good Practices for Transforming Value Assessment: Patients' Voices, Patients' Values.

PubMed

Perfetto, Eleanor M; Harris, Jason; Mullins, C Daniel; dosReis, Susan

2018-04-01

Patient engagement is a transformative strategy for improving value assessment. US value framework developers have increased engagement activities, but more needs to be learned about how to best achieve meaningful patient engagement in value assessment. The objective was to glean good practices in patient engagement emerging from patient community experiences, to be used in value assessment. The National Health Council Value Workgroup conducted a survey and held a focus group with its member advocacy organizations to gather experiences with value framework developers and views on emerging good practices. Ten of 13 organizations completed the survey; reporting 13 interactions with four framework developers. Most rated experiences as "good" to "very good." Emerging good practices included (1) engage early; (2) engage a range of patients; (3) leverage patient-provided information, data resources, and outreach mechanisms; (4) be transparent; and (5) appreciate and accommodate resource constraints. Twelve of 13 organizations participated in the focus group, and this produced 30 emerging good practices in four areas: (1) timing; (2) methodology and data; (3) partnering; and (4) characterizing engagement. Patient engagement was limited in early development of value frameworks but has increased in the past few years. Patient groups report positive experiences that can serve as emerging good practices. These groups also reported experienced challenges in their interactions and recommended good practices to mitigate those challenges. The growing pool of patient engagement experiences can be translated into good practices to advance a patient-centered, value-driven health care ecosystem. Lessons learned from these early experiences can help establish recommend emerging good practices that can eventually result in best practices and standards in the field. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

The Application of Voltage Transformer Simulator in Electrical Test Training

NASA Astrophysics Data System (ADS)

Li, Nan; Zhang, Jun; Chai, Ziqi; Wang, Jingpeng; Yang, Baowei

2018-02-01

The voltage transformer test is an important means to monitor its operating state. The accuracy and reliability of the test data is directly related to the test skill level of the operator. However, the risk of test instruments damage, equipment being tested damage and electric shock in operator is caused by improper operation when training the transformer test. In this paper, a simulation device of voltage transformer is set up, and a simulation model is built for the most common 500kV capacitor voltage transformer (CVT), the simulation model can realize several test items of CVT by combing with teaching guidance platform, simulation instrument, complete set of system software and auxiliary equipment in Changchun. Many successful applications show that the simulation device has good practical value and wide application prospect.

Good practices in Local Government - A first overview of Portuguese reality

NASA Astrophysics Data System (ADS)

Carvalhosa, P.; Portela, F.; Machado, J.; Santos, M. F.; Abelha, A.

2017-03-01

Good practices in eGov are being increasingly used by Local Governments being that it is considered by them as an advantage. The main goal is providing to the town hall a differentiation point and approximate their services to the citizens. For this, it is necessary to define and apply innovative strategies in order to increase the use of services by the citizens. This paper is framed in a research work and it presents a first overview of the existing good practices in eGov, taking in consideration the Portuguese’s reality. The good practices identified were distinguished with many awards and with a positive response from the target audience. The use of digital marketing strategies aims to increase their membership and coming closer the municipalities of its citizens through the dissemination of the good practices. At this moment the data collected are almost exclusively of good practice in Portugal, however some international practices were also identified. As a result of this study the community has a list of good practices that can be applied in their municipalities.

Good practice in reviewing and publishing studies on herbal medicine, with special emphasis on traditional Chinese medicine and Chinese materia medica.

PubMed

Chan, Kelvin; Shaw, Debbie; Simmonds, Monique S J; Leon, Christine J; Xu, Qihe; Lu, Aiping; Sutherland, Ian; Ignatova, Svetlana; Zhu, You-Ping; Verpoorte, Rob; Williamson, Elizabeth M; Duez, Pierre

2012-04-10

Studies on traditional Chinese medicine (TCM), like those of other systems of traditional medicine (TM), are very variable in their quality, content and focus, resulting in issues around their acceptability to the global scientific community. In an attempt to address these issues, an European Union funded FP7 consortium, composed of both Chinese and European scientists and named "Good practice in traditional Chinese medicine" (GP-TCM), has devised a series of guidelines and technical notes to facilitate good practice in collecting, assessing and publishing TCM literature as well as highlighting the scope of information that should be in future publications on TMs. This paper summarises these guidelines, together with what has been learned through GP-TCM collaborations, focusing on some common problems and proposing solutions. The recommendations also provide a template for the evaluation of other types of traditional medicine such as Ayurveda, Kampo and Unani. GP-TCM provided a means by which experts in different areas relating to TCM were able to collaborate in forming a literature review good practice panel which operated through e-mail exchanges, teleconferences and focused discussions at annual meetings. The panel involved coordinators and representatives of each GP-TCM work package (WP) with the latter managing the testing and refining of such guidelines within the context of their respective WPs and providing feedback. A Good Practice Handbook for Scientific Publications on TCM was drafted during the three years of the consortium, showing the value of such networks. A "deliverable - central questions - labour division" model had been established to guide the literature evaluation studies of each WP. The model investigated various scoring systems and their ability to provide consistent and reliable semi-quantitative assessments of the literature, notably in respect of the botanical ingredients involved and the scientific quality of the work described. This resulted in the compilation of (i) a robust scoring system and (ii) a set of minimum standards for publishing in the herbal medicines field, based on an analysis of the main problems identified in published TCM literature. Good quality, peer-reviewed literature is crucial in maintaining the integrity and the reputation of the herbal scientific community and promoting good research in TCM. These guidelines provide a clear starting point for this important endeavour. They also provide a platform for adaptation, as appropriate, to other systems of traditional medicine. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Securing the Adoption of Good Practice in Scotland's Colleges. A Report by HM Inspectors of Education for the Scottish Funding Council

ERIC Educational Resources Information Center

Her Majesty's Inspectorate of Education, 2006

2006-01-01

The purpose of this report is to describe the main mechanisms currently in use in Scotland's colleges to ensure that the adoption of good practice actually happens. It investigates how colleges identify and promote good practice in their own institutions; how they develop strategies and processes to ensure good practice is shared, adopted and…

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2014 CFR

2014-04-01

... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient... levels not to exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this...

The virtuous pathologist. An ethical basis for laboratory medicine.

PubMed

Stempsey, W E

1989-06-01

The profession of pathology is a practice in the technical sense used by many philosophers. Such practices have internal goods, which, it is hoped, lead to the attainment of a certain end. The ultimate end of the practice of pathology must be the good of the patient in terms of restoring health. Key internal goods in pathology are technical competence, the proper pathologist-patient relationship, and the proper pathologist-clinician relationship. Virtues are predispositions to act so as to attain the end of the practice and further the internal goods. Technical growth in the practice of pathology must be accompanied by continued attempts to articulate the goals and internal goods of the practice. Only if pathologists are predisposed to act in accordance with proper goals will an ethical practice be assured.

[Good drug distribution practice and its implementation in drug distribution companies].

PubMed

Draksiene, Gailute

2002-01-01

Good Distribution Practice is based on the Directive of the Board of the European Community 92/25/EEC regarding the wholesale distribution of drugs for human consumption. It is stated in the Directive that the whole drug distribution channel is to be controlled from the point of drug production or import down to the supplies to the end user. In order to reach the goal, the drug distribution company must create the quality assurance system and facilitate its correct functioning. This aim requires development of the rules of the Good Distribution Practice. Those rules set the general requirements of the Good Distribution Practice for distribution companies that they must conduct. The article explains main requirements postulated in the rules of the Good Distribution Practice and implementation of the Good Distribution Practice requirements in drug distribution companies.

An assessment of maintainability of elevator system to improve facilities management knowledge-base

NASA Astrophysics Data System (ADS)

Siti, N. A.; Asmone, A. S.; Chew, M. Y. L.

2018-02-01

Elevator system is a highly specialized machinery that requires technicians that have a wider array of knowledge in maintaining the system to be safe and reliable. While attaining reliable data of elevator malfunction become challenges, this study has filled the gap by gathering the management-maintenance issues and operational defects of elevator system. Forty-three types of operation defects were found and the consequence defects and their possible causes of occurrences were discussed. To respond to the prime challenges of maintaining elevator system provided by the industry players’ perspective, a theoretical framework is established as a recommendation to improve knowledge base of defects in elevator system which comprises good practices, and solutions to rectify each defects found. Hence, this research paper has theoretically improved the knowledge base of maintainability of elevator system and provide meaningful guidelines in practical senses to the industry professionals.

Surgical ethics: surgical virtue and more.

PubMed

Vercler, Christian J

2015-01-01

The encounter between a patient and her surgeon is unique for several reasons. The surgeon inflicts pain upon a patient for the patient's own good. An operative intervention is irreducibly personal, such that the decisions about and performance of operations are inseparable from the idiosyncrasies of the individual surgeon. Furthermore, there is a chasm of knowledge between the patient and surgeon that is difficult to cross. Hence, training in the discipline of surgery includes the inculcation of certain virtues and practices to safeguard against abuses of this relationship and to make sure that the best interests of the patient are prioritized. The stories in this issue are evidence that in contemporary practice this is not quite enough, as surgeons reflect on instances they felt were ethically challenging. Common themes include the difficulty in communicating surgical uncertainty, patient-surgeon relationships, ethical issues in surgical training, and the impact of the technological imperative on caring for dying patients.

[Identification of Good-Practice Projects in Promoting Physical Activity - Methods, Pitfalls and Sampled Outcomes].

PubMed

Henn, Annette; Karger, Claudia; Wöhlken, Katrin; Meier, Diana; Ungerer-Röhrich, Ulrike; Graf, Christine; Woll, Alexander

2017-03-01

The aim of this paper is to identify and show examples of good practice of public health promotion. For this, uniform quality criteria were worked out under consideration of national and international scientific literature.For the identification of examples of good practice, a comparison of different quality criteria was carried out and combined with each other in a first step. In the following step, examples of good practice were identified after a comprehensive search. The choice of the "good-practice" projects is exemplary and lays no claim to completeness.6 main quality criteria (QC) of programs promoting physical activity could be identified in the national and international context. The analysis showed altogether 10 projects which can exemplarily be classified as examples of good practice of the target groups of children and teenagers, adults, older people and people with pre-existing illnesses. These projects, however, show major differences in their (methodological) quality.The analysis reports a lack of "Good-Practice" examples. Deficits lie mainly in documentation and sustainability. Because of incomplete documentation, an assessment as a "Good-Practice" example is only possible to a limited extent; a lot of information, particularly in the evaluation, is missing. © Georg Thieme Verlag KG Stuttgart · New York.

Good manufacturing practices production of a purification-free oral cholera vaccine expressed in transgenic rice plants.

PubMed

Kashima, Koji; Yuki, Yoshikazu; Mejima, Mio; Kurokawa, Shiho; Suzuki, Yuji; Minakawa, Satomi; Takeyama, Natsumi; Fukuyama, Yoshiko; Azegami, Tatsuhiko; Tanimoto, Takeshi; Kuroda, Masaharu; Tamura, Minoru; Gomi, Yasuyuki; Kiyono, Hiroshi

2016-03-01

The first Good Manufacturing Practices production of a purification-free rice-based oral cholera vaccine (MucoRice-CTB) from transgenic plants in a closed cultivation system yielded a product meeting regulatory requirements. Despite our knowledge of their advantages, plant-based vaccines remain unavailable for human use in both developing and industrialized countries. A leading, practical obstacle to their widespread use is producing plant-based vaccines that meet governmental regulatory requirements. Here, we report the first production according to current Good Manufacturing Practices of a rice-based vaccine, the cholera vaccine MucoRice-CTB, at an academic institution. To this end, we established specifications and methods for the master seed bank (MSB) of MucoRice-CTB, which was previously generated as a selection-marker-free line, evaluated its propagation, and given that the stored seeds must be renewed periodically. The production of MucoRice-CTB incorporated a closed hydroponic system for cultivating the transgenic plants, to minimize variations in expression and quality during vaccine manufacture. This type of molecular farming factory can be operated year-round, generating three harvests annually, and is cost- and production-effective. Rice was polished to a ratio of 95 % and then powdered to produce the MucoRice-CTB drug substance, and the identity, potency, and safety of the MucoRice-CTB product met pre-established release requirements. The formulation of MucoRice-CTB made by fine-powdering of drug substance and packaged in an aluminum pouch is being evaluated in a physician-initiated phase I study.

Sanitary conditions of food vending sites and food handling practices of street food vendors in Benin City, Nigeria: implication for food hygiene and safety.

PubMed

Okojie, P W; Isah, E C

2014-01-01

To determine the sanitary conditions of vending sites as well as food handling practices of street food vendors in Benin City, Nigeria. A descriptive cross-sectional study was done using an observational checklist and researcher-administered questionnaire. 286 randomly selected vending units were surveyed, and their operators interviewed on their food handling practices. A higher proportion, 259 (90.5%), of the observed vending sites appeared clean. The following sanitary facilities were observed in and around the respective food premises of the respondents: waste bin, 124 (43.4%), refuse dumpsite, 41 (14.3%), wash hand basin, 201 (71.2%), hand towel, 210 (73.4%), and soap, 220 (76.9%). There were also the presence of flies 118, (41.3%), and the presence of rats/cockroaches, 7 (2.4%). Respondents with tertiary education, 5 (38.5%), vended foods in environment with good hygiene status compared to those with secondary, 45 (31.7%), and primary education, 33 (27.3%). There was no statistically significant association between educational status and the hygiene status of food premise (P = 0.362). This study showed that street food vending sites in Benin City were sanitary and that food vendors had good food handling practices.

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..., methods, practices, and controls used in the processing, bottling, holding, and shipping of bottled...

Teleworking: Guidelines for Good Practice. IES Report 329.

ERIC Educational Resources Information Center

Huws, Ursula; And Others

Because teleworking presents major new challenges to human resource managers, trade unions, and others involved in the development of good employment practices, this book provides practical guidelines for good practice in regard to teleworkers that recognize that teleworking is not a single category, but covers at least five distinct groups with…

Data Sharing to Improve Close Approach Monitoring and Safety of Flight

NASA Astrophysics Data System (ADS)

Chan, Joseph; DalBello, Richard; Hope, Dean; Wauthier, Pascal; Douglas, Tim; Inghram, Travis

2009-03-01

Individual satellite operators have done a good job of developing the internal protocols and procedures to ensure the safe operation of their fleets. However, data sharing among operators for close approach monitoring is conducted in an ad-hoc manner during relocations, and there is currently no standardized agreement among operators on the content, format, and distribution protocol for data sharing. Crowding in geostationary orbit, participation by new commercial actors, government interest in satellite constellations, and highly maneuverable spacecraft all suggest that satellite operators will need to begin a dialogue on standard communication protocols and procedure to improve situation awareness. We will give an overview of the current best practices among different operators for close approach monitoring and discuss the concept of an active data center to improve data sharing, conjunction monitoring, and avoidance among satellite operators. We will also report on the progress and lessons learned from a Data Center prototype conducted by several operators over a one year period.

21 CFR 184.1101 - Diacetyl tartaric acid esters of mono- and diglycerides.

Code of Federal Regulations, 2010 CFR

2010-04-01

... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used in food as an... levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in...

21 CFR 184.1101 - Diacetyl tartaric acid esters of mono- and diglycerides.

Code of Federal Regulations, 2011 CFR

2011-04-01

... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used in food as an... levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in...

Protection of people and environment from radiation risk through good regulatory practice

NASA Astrophysics Data System (ADS)

Jais, Azlina Mohammad; Hassan, Najwa

2017-01-01

The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be considered by nuclear regulatory authority and the necessary criteria of an "ideal" how nuclear regulatory authority should implement the "good regulatory practice" approach.

Preoperative Site Marking: Are We Adhering to Good Surgical Practice?

PubMed

Bathla, Sonia; Chadwick, Michael; Nevins, Edward J; Seward, Joanna

2017-06-29

Wrong-site surgery is a never event and a serious, preventable patient safety incident. Within the United Kingdom, national guidance has been issued to minimize the risk of such events. The mandate includes preoperative marking of all surgical patients. This study aimed to quantify regional variation in practice within general surgery and opinions of the surgeons, to help guide the formulation and implementation of a regional general surgery preoperative marking protocol. A SurveyMonkey questionnaire was designed and distributed to 120 surgeons within the Mersey region, United Kingdom. This included all surgical trainees in Mersey (47 registrars, 56 core trainees), 15 consultants, and 2 surgical care practitioners. This sought to ascertain their routine practice and how they would choose to mark for 12 index procedures in general surgery, if mandated to do so. A total of 72 responses (60%) were obtained to the SurveyMonkey questionnaire. Only 26 (36.1%) said that they routinely marked all of their patients preoperatively. The operating surgeon marked the patient in 69% of responses, with the remainder delegating this task. Markings were visible after draping in only 55.6% of marked cases. Based on our findings, surgeons may not be adhering to "Good Surgical Practice"; practice is widely variable and surgeons are largely opposed and resistant to marking patients unless laterality is involved. We suggest that all surgeons need to be actively engaged in the design of local marking protocols to gain support, change practice, and reduce errors.

Control banding assessment of workers' exposure to indium and its compounds in 13 Japanese indium plants.

PubMed

Higashikubo, Ichiro; Arito, Heihachiro; Ando, Kenji; Araki, Akihiro; Shimizu, Hidesuke; Sakurai, Haruhiko

2018-05-25

This study aimed to assess workers' exposure to indium and its compounds in 55 indium-handling operations among 13 Japanese plants. The surveyed plants were selected from indium-manufacturing plants whose annual indium production exceeded 500 kg. The Control of Substances Hazardous to Health (COSHH) Essentials control banding toolkit, which contains simple scales for hazard levels, quantities in daily use, and "dustiness" characteristics, was used to assess generic risks of indium-handling operations. The operations were then classified into one of four Control Approaches (CAs). There were 35 indium-handling operations classified into CA4 (requires expert advice) and 16 grouped into CA3 (requires containment). There were three operations classified into CA2 (requires engineering controls) and only one into CA1 (requires good general ventilation (GV) and working practices). Of the 51 operations classified as CA4 and CA3, 36 were found to be improperly equipped with local exhaust ventilation, and the remaining 15 operations solely relied on GV practices. Respiratory protective equipment (RPE) used in the 13 indium plants was examined with reference to the recommendations of the COSHH Essentials and Japan's Technical Guidelines. Our findings suggest that stringent engineering control measures and respiratory protection from indium dust are needed to improve indium-handling operations. Our results show that the most common control approach for Japanese indium-handling operations is to require expert advice, including worker health checks for respiratory diseases and exposure measurement by air sampling.

Practices in security and confidentiality of HIV/AIDS patients’ information: A national survey among staff at HIV outpatient clinics in Vietnam

PubMed Central

Khac Hai, Nguyen; Lawpoolsri, Saranath; Jittamala, Podjanee; Thi Thu Huong, Phan

2017-01-01

Introduction Breach of confidentiality or invasion of privacy from the collection and use of medical records, particularly those of patients with HIV/AIDS or other diseases sensitive to stigmatization, should be prevented by all related stakeholders in healthcare settings. The main focus of this study was to assess practices regarding security and confidentiality of HIV-related information among staff at HIV outpatient clinics (HIV-OPCs) in Vietnam. Methods A descriptive cross-sectional study was conducted at all 312 HIV-OPCs across the country using an online survey technique. Results In general, the staff practices for securing and protecting patient information were at acceptable levels. Most staff had proper measures and practices for maintaining data security; however, the protection of patient confidentiality, particularly for data access, sharing, and transfer still required improvement. Most HIV-OPC staff had good or moderate knowledge and positive perceptions towards security and confidentiality issues. Staff who were not trained in the practice of security measures differed significantly from those who were trained (OR: 3.74; 95%CI: 1.44–9.67); staff needing improved knowledge levels differed significantly from those with good (OR: 5.20; 95%CI: 2.39–11.32) and moderate knowledge levels (OR: 5.10; 95%CI: 2.36–11.00); and staff needing improved perception levels differed significantly from those with good (i.e., with 100% proper practices) and moderate perception levels (OR: 5.67; 95%CI: 2.93–10.95). Staff who were not trained in the protection of data confidentiality differed significantly from those who were trained (OR: 2.18; 95%CI: 1.29–3.65). Conclusions Training is an important factor to help raise the levels of proper practices regarding confidentiality and security, to improve knowledge and raise awareness about change among staff. The operation and management of HIV treatment and care in Vietnam are currently transitioning from separate healthcare clinics (HIV-OPC) into units integrated into general hospitals/healthcare facilities. The findings of this study highlight topics that could be used for improving management and operation of information system and revising guidelines and regulations on protection measures/strategies for data security and confidentiality of HIV/AIDS patients by Vietnam health authorities or other countries facing similar situations. Secure infrastructure and secure measures for data access and use are very important, worthwhile investments. The provision of continuous training and active enforcement and monitoring of the practices of healthcare personnel might lead to an improved understanding and acknowledegement of the importance of national policies/guidelines regarding HIV-related patient information. PMID:29136017

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... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10, 113.40..., methods, practices, and controls used by the commercial processor in the manufacture, processing, or...

Screening the use of informed consent forms prior to procedures involving operative dentistry: ethical aspects

PubMed Central

Graziele Rodrigues, Livia; De Souza, João Batista; De Torres, Erica Miranda; Ferreira Silva, Rhonan

2017-01-01

Background. The present study aimed to screen the knowledge and attitudes of dentists toward the use of informed consent forms prior to procedures involving operative dentistry. Methods. A research tool containing questions (questionnaire) regarding the use of informed consent forms was developed. The questionnaire consisted of seven questions structured to screen the current practice in operative dentistry towards the use of informed consent forms. Results. The questionnaires were distributed among 731 dentists, of which 179 returned them with answers. Sixty-seven dentists reported not using informed consent forms. The main reasons for not using informed consent forms were: having a complete dental record signed by the patient (67.2%) and having a good relation with patients (43.6%). The dentists who reported using informed consent forms revealed that they obtained them from other dentists and made their own modifications (35.9%). Few dentists revealed contacting lawyers (1.7%) and experts in legal dentistry (0.9%) for the development of their informed consent forms. Conclusion. A high number of dentists working in the field of operative dentistry behave according to the ethical standards in the clinical practice, becoming unprotected against ethical and legal actions. PMID:28413600

Research requirements to reduce maintenance costs of civil helicopters

NASA Technical Reports Server (NTRS)

Million, D. J.; Waters, K. T.

1978-01-01

The maintenance problems faced by the operators of civil helicopters that result in high costs are documented. Existing technology that can be applied to reduce maintenance costs and research that should be carried out were identified. Good design practice and application of existing technology were described as having a significant impact on reducing maintenance costs immediately. The research and development that have potential for long range reduction of maintenance costs are presented.

Top 10 metrics for life science software good practices.

PubMed

Artaza, Haydee; Chue Hong, Neil; Corpas, Manuel; Corpuz, Angel; Hooft, Rob; Jimenez, Rafael C; Leskošek, Brane; Olivier, Brett G; Stourac, Jan; Svobodová Vařeková, Radka; Van Parys, Thomas; Vaughan, Daniel

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.

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. PMID:27635232

NIOSH testimony to DOL on the Occupational Safety And Health Administration's proposed rule on occupational exposure to asbestos, tremolite, anthophyllite, and actinolite by J. D. Millar, January 24, 1991

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1991-01-24

The testimony contains the comments of NIOSH regarding the proposed rule on occupational exposure to asbestos (1332214), tremolite (14567738), anthophyllite (17068789) and actinolite (77536664) exposures. NIOSH supports OSHA in proposing changes to the existing asbestos standard to minimize the risk of asbestos related diseases in workers. The current standard is insufficient to protect the health of workers exposed to asbestos, and the proposed changes represent a prudent and necessary approach to accomplish this goal. Specific topics addressed in the testimony include exposure limits for asbestos; methods for sampling and analysis of airborne fibers; use of time weighted averages to measuremore » exposure; use of engineering controls, good work practices and personal protective equipment; use of engineering controls and work practices for brake and clutch repair and service; required use of specific work practices during maintenance of vinyl asbestos floor tile; housekeeping; definitions of small scale and short duration operations; exemption of roofing operations from the requirement for negative pressure enclosures; communication among employers and owners; regulated areas for asbestos removal, maintenance, demolition, and renovation operations; use of glove bags; definition of competent person; and notification to OSHA and method of notification.« less

From skin biopsy to neurons through a pluripotent intermediate under Good Manufacturing Practice protocols.

PubMed

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; Lowry, William E

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.

Ordering competition: the interactional accomplishment of the sale of art and antiques at auction.

PubMed

Heath, Christian; Luff, Paul

2007-03-01

Auctions provide an institutional solution to a social problem; they enable the legitimate pricing and exchange of goods where those goods are of uncertain value. In turn, auctions raise a number of social and organizational issues that are resolved within the interaction that arise in sales by auction. In this paper, we examine sales of fine art, antiques and objets d'art and explore the ways in which auctioneers mediate competition between buyers and establish a value for goods. In particular, we explore how bids are elicited, co-ordinated and revealed so as to rapidly escalate the price of goods in a transparent manner that enables the legitimate valuation and exchange of goods. In directing attention towards the significance of the social interaction, including talk, visual and material conduct, the paper contributes to the growing corpus of ethnographic studies of markets. It suggests that to understand the operation of markets and their outcomes, and to unpack issues of agency, trust and practice, we need to place the 'interaction order' at the heart of analytic agenda.

Good practices in transportation evacuation preparedness and response : results of the FHWA workshop series.

DOT National Transportation Integrated Search

2009-08-01

This document provides an overview of the good practices identified during a series of multi-state workshops on Transportation Evacuation Preparedness and Response in four regions across the United States. Good practices are not presented in priority...

Good practices in transportation evacuation preparedness and response : results of the FHWA Workshop Series

DOT National Transportation Integrated Search

2009-08-01

This document provides an overview of the good practices identified during a series of multi-state workshops on Transportation Evacuation Preparedness and Response in four regions across the United States. Good practices are not presented in priority...

[Software for illustrating a cost-quality balance carried out by clinical laboratory practice].

PubMed

Nishibori, Masahiro; Asayama, Hitoshi; Kimura, Satoshi; Takagi, Yasushi; Hagihara, Michio; Fujiwara, Mutsunori; Yoneyama, Akiko; Watanabe, Takashi

2010-09-01

We have no proper reference indicating the quality of clinical laboratory practice, which should clearly illustrates that better medical tests require more expenses. Japanese Society of Laboratory Medicine was concerned about recent difficult medical economy and issued a committee report proposing a guideline to evaluate the good laboratory practice. According to the guideline, we developed software that illustrate a cost-quality balance carried out by clinical laboratory practice. We encountered a number of controversial problems, for example, how to measure and weight each quality-related factor, how to calculate costs of a laboratory test and how to consider characteristics of a clinical laboratory. Consequently we finished only prototype software within the given period and the budget. In this paper, software implementation of the guideline and the above-mentioned problems are summarized. Aiming to stimulate these discussions, the operative software will be put on the Society's homepage for trial

WHO Expert Committee on specifications for pharmaceutical preparations.

PubMed

2010-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: good practices for pharmaceutical quality control laboratories; supplementary guidelines for active pharmaceutical ingredients; good manufacturing practices for pharmaceutical products containing hazardous substances; good manufacturing practices for sterile pharmaceutical products; good distribution practices for pharmaceutical products; guidelines on the requalification of prequalified dossiers: and guidelines for the preparation of a contract research organization master file.

Narrative Practice and the Signs of Safety Approach: Engaging Adolescents in Building Rigorous Safety Plans

ERIC Educational Resources Information Center

Gibson, Matthew

2014-01-01

The Signs of Safety approach to child protection has been gaining prominence around the world and this approach has developed through learning from good practice. Generally, examples of good practice are derived from adults who pose a risk to children, while this paper outlines an example of good practice that engages an adolescent in building a…

Perceptions of Science Teachers on Implementation of Seven Principles for Good Practice in Education by Chickering and Gamson in Courses

ERIC Educational Resources Information Center

Ugras, Mustafa; Asiltürk, Erol

2018-01-01

The present study aimed to determine the perceptions of science teachers on the implementation of the seven principles for good practice in education by Chickering and Gamson in their courses. Seven principles for good science education were used as a data collection tool in the survey. "The seven principles for good practice in science…

Factors associated with good TB infection control practices among primary healthcare workers in the Free State Province, South Africa.

PubMed

Engelbrecht, Michelle; Janse van Rensburg, André; Kigozi, Gladys; van Rensburg, Hcj Dingie

2016-11-04

Despite the availability of TB infection control guidelines, and good levels of healthcare worker knowledge about infection control, often these measures are not well implemented. This study sought to determine the factors associated with healthcare workers' good TB infection control practices in primary health care facilities in the Free State Province, South Africa. A cross-sectional self-administered survey among nurses (n = 202) and facility-based community healthcare workers (n = 34) as well as facility observations were undertaken at all 41 primary health care facilities in a selected district of the Free State Province. The majority of respondents were female (n = 200; 87.7 %) and the average age was 44.19 years (standard deviation ±10.82). Good levels of knowledge were recorded, with 42.8 % (n = 101) having an average score (i.e. 65-79 %) and 31.8 % (n = 75) a good score (i.e. ≥ 80 %). Most respondents (n = 189; 80.4 %) had positive attitudes towards TB infection control practices (i.e. ≥ 80 %). While good TB infection control practices were reported by 72.9 % (n = 161) of the respondents (i.e. ≥75 %), observations revealed this to not necessarily be the case. For every unit increase in attitudes, good practices increased 1.090 times (CI:1.016-1.169). Respondents with high levels of knowledge (≥80 %) were 4.029 (CI: 1.550-10.469) times more likely to have good practices when compared to respondents with poor levels of knowledge (<65 %). The study did not find TB/HIV-related training to be a predictor of good practices. Positive attitudes and good levels of knowledge regarding TB infection control were the main factors associated with good infection control practices. Although many respondents reported good infection control practices - which was somewhat countered by the observations - there are areas that require attention, particularly those related to administrative controls and the use of personal protective equipment.

Improving Strength-Ductility Balance of High Strength Dual-Phase Steels by Addition of Vanadium

NASA Astrophysics Data System (ADS)

Gong, Yu; Hua, M.; Uusitalo, J.; DeArdo, A. J.

For galvanized or galvannealed steels to be commercially successful, they must exhibit several attributes: (i) easy and inexpensive processing in the hot mill, cold mill and on the coating line, (ii) high strength with good formability and spot weldability, and (iii) good corrosion resistance, especially after cold forming. For good corrosion resistance, the coating must have sufficient coverage, be of uniform thickness, and most importantly, the coating must survive the cold stamping or forming operation. The purpose of this paper is to present research aiming at improving the steel substrate, such that high strength can be obtained while maintaining good global formability (tensile ductility), local formability (sheared-edge ductility), and good spot weldability. It is well-known that the strength of DP steels is controlled by several factors, including the amount of martensite found in the final microstructure. Recent research has revealed that the amount of austenite formed during intercritical annealing can be strongly influenced by the annealing temperature and the pre-annealing conditions of the hot band (coiling temperature) and cold band (% cold reduction). Current experiments have explored the combination of pre-annealing conditions and four annealing practices to help define the best practice to optimize the strength-formability balance in these higher strength DP steels. The steels used in these experiments contained (i) low carbon content for good spot weldability, (ii) the hardenability additions Mo and Cr for strength, and (iii) V for grain refinement, precipitation hardening and temper resistance. When processed correctly, these steels exhibited UTS levels up to 1000MPa, total elongation to 25%, reduction in area to 45%, and Hole Expansion Ratios to 50%. The results of this program will be presented and discussed.

The promise--and peril--of integrated cost systems.

PubMed

Cooper, R; Kaplan, R S

1998-01-01

Recent advances in managerial accounting have helped executives get the information they need to make good strategic decisions. But today's enterprise resource planning systems promise even greater benefits--the chance to integrate activity-based costing, operational-control, and financial reporting systems. But managers need to approach integration very thoughtfully, or they could end up with a system that drives decision making in the wrong direction. Operational-control and ABC systems have fundamentally different purposes. Their requirements for accuracy, timeliness, and aggregation are so different that no single, fully integrated approach can be adequate for both purposes. If an integrated system used real-time cost data instead of standard rates in its ABC subsystem, for example, the result would be dangerously distorted messages about individual product profitability--and that's precisely the problem ABC systems were originally designed to address. Proper linkage and feedback between the two systems is possible, however. Through activity-based budgeting, the ABC system is linked directly to operations control: managers can determine the supply and practical capacity of resources in forthcoming periods. Linking operational control to ABC is also possible. The activity-based portion of an operational control system collects information that, while it mustn't be fed directly into the activity-based strategic cost system, can be extremely useful once it's been properly analyzed. Finally, ABC and operational control can be linked to financial reporting to generate cost of goods sold and inventory valuations--but again, with precautions.

Auditing radiation sterilization facilities

NASA Astrophysics Data System (ADS)

Beck, Jeffrey A.

The diversity of radiation sterilization systems available today places renewed emphasis on the need for thorough Quality Assurance audits of these facilities. Evaluating compliance with Good Manufacturing Practices is an obvious requirement, but an effective audit must also evaluate installation and performance qualification programs (validation_, and process control and monitoring procedures in detail. The present paper describes general standards that radiation sterilization operations should meet in each of these key areas, and provides basic guidance for conducting QA audits of these facilities.

[Design of a miniaturized blood temperature-varying system based on computer distributed control].

PubMed

Xu, Qiang; Zhou, Zhaoying; Peng, Jiegang; Zhu, Junhua

2007-10-01

Blood temperature-varying has been widely applied in clinical practice such as extracorporeal circulation for whole-body perfusion hyperthermia (WBPH), body rewarming and blood temperature-varying in organ transplantation. This paper reports a novel DCS (Computer distributed control)-based blood temperature-varying system which includes therapy management function and whose hardware and software can be extended easily. Simulation results illustrate that this system provides precise temperature control with good performance in various operation conditions.

Good Seeing: Best Practices for Sustainable Operations at the Air Force Maui Optical and Supercomputing Site

DTIC Science & Technology

2016-01-01

supportive of this work from the start . This research would not have been possible without the contributions made by a number of individuals throughout...and funding structures. We started with these questions in particular based on the primary concerns at AMOS identified in the results of Phase I...from the start . Keck maintains connections with a series of other sites within a remote observing network. Remote observing from the mainland

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...

Establishment and operation of a Good Manufacturing Practice-compliant allogeneic Epstein-Barr virus (EBV)-specific cytotoxic cell bank for the treatment of EBV-associated lymphoproliferative disease

PubMed Central

Vickers, Mark A; Wilkie, Gwen M; Robinson, Nicolas; Rivera, Nadja; Haque, Tanzina; Crawford, Dorothy H; Barry, Jacqueline; Fraser, Neil; Turner, David M; Robertson, Victoria; Dyer, Phil; Flanagan, Peter; Newlands, Helen R; Campbell, John; Turner, Marc L

2014-01-01

Epstein-Barr virus (EBV) is associated with several malignancies, including post-transplant lymphoproliferative disorder (PTLD). Conventional treatments for PTLD are often successful, but risk organ rejection and cause significant side effects. EBV-specific cytotoxic T lymphocytes (CTLs) generated in vitro from peripheral blood lymphocytes provide an alternative treatment modality with few side effects, but autologous CTLs are difficult to use in clinical practice. Here we report the establishment and operation of a bank of EBV-specific CTLs derived from 25 blood donors with human leucocyte antigen (HLA) types found at high frequency in European populations. Since licensure, there have been enquiries about 37 patients, who shared a median of three class I and two class II HLA types with these donors. Cells have been infused into ten patients with lymphoproliferative disease, eight of whom achieved complete remission. Neither patient with refractory disease was matched for HLA class II. Both cases of EBV-associated non-haematopoietic sarcoma receiving cells failed to achieve complete remission. Thirteen patients died before any cells could be issued, emphasizing that the bank should be contacted before patients become pre-terminal. Thus, this third party donor-derived EBV-specific CTL cell bank can supply most patients with appropriately matched cells and most recipients have good outcomes. PMID:25066775

Hazard Analysis and Critical Control Points among Chinese Food Business Operators.

PubMed

Saccares, Stefano; Amadei, Paolo; Masotti, Gianfranco; Condoleo, Roberto; Guidi, Alessandra

2014-08-28

The purpose of the present paper is to highlight some critical situations emerged during the implementation of long-term projects locally managed by Prevention Services, to control some manufacturing companies in Rome and Prato, Central Italy. In particular, some critical issues on the application of self-control in marketing and catering held by Chinese operators are underlined. The study showed serious flaws in preparing and controlling of manuals for good hygiene practice, participating of the consultants among food business operators (FBOs) to the control of the procedures. Only after regular actions by the Prevention Services, there have been satisfying results. This confirms the need to have qualified and expert partners able to promptly act among FBOs and to give adequate support to authorities in charge in order to guarantee food safety.

Using the Nine Common Themes of Good Practice checklist as a tool for evaluating the research priority setting process of a provincial research and program evaluation program.

PubMed

Mador, Rebecca L; Kornas, Kathy; Simard, Anne; Haroun, Vinita

2016-03-23

Given the context-specific nature of health research prioritization and the obligation to effectively allocate resources to initiatives that will achieve the greatest impact, evaluation of priority setting processes can refine and strengthen such exercises and their outcomes. However, guidance is needed on evaluation tools that can be applied to research priority setting. This paper describes the adaption and application of a conceptual framework to evaluate a research priority setting exercise operating within the public health sector in Ontario, Canada. The Nine Common Themes of Good Practice checklist, described by Viergever et al. (Health Res Policy Syst 8:36, 2010) was used as the conceptual framework to evaluate the research priority setting process developed for the Locally Driven Collaborative Projects (LDCP) program in Ontario, Canada. Multiple data sources were used to inform the evaluation, including a review of selected priority setting approaches, surveys with priority setting participants, document review, and consultation with the program advisory committee. The evaluation assisted in identifying improvements to six elements of the LDCP priority setting process. The modifications were aimed at improving inclusiveness, information gathering practices, planning for project implementation, and evaluation. In addition, the findings identified that the timing of priority setting activities and level of control over the process were key factors that influenced the ability to effectively implement changes. The findings demonstrate the novel adaptation and application of the 'Nine Common Themes of Good Practice checklist' as a tool for evaluating a research priority setting exercise. The tool can guide the development of evaluation questions and enables the assessment of key constructs related to the design and delivery of a research priority setting process.

Proposal on a sustainable strategy to avoid point source pollution of water with plant protection products.

PubMed

Mestdagh, Inge; Bonicelli, Bernard; Laplana, Ramon; Roettele, Manfred

2009-01-01

Based on the results and lessons learned from the TOPPS project (Training the Operators to prevent Pollution from Point Sources), a proposal on a sustainable strategy to avoid point source pollution from Plant Protection Products (PPPs) was made. Within this TOPPS project (2005-2008), stakeholders were interviewed and research and analysis were done in 6 pilot catchment areas (BE, FR, DE, DK, IT, PL). Next, there was a repeated survey on operators' perception and opinion to measure changes resulting from TOPPS activities and good and bad practices were defined based on the Best Management Practices (risk analysis). Aim of the proposal is to suggest a strategy considering the differences between countries which can be implemented on Member State level in order to avoid PPP pollution of water through point sources. The methodology used for the up-scaLing proposal consists of the analysis of the current situation, a gap analysis, a consistency analysis and organisational structures for implementation. The up-scaling proposal focuses on the behaviour of the operators, on the equipment and infrastructure available with the operators. The proposal defines implementation structures to support correct behaviour through the development and updating of Best Management Practices (BMPs) and through the transfer and the implementation of these BMPs. Next, the proposal also defines requirements for the improvement of equipment and infrastructure based on the defined key factors related to point source pollution. It also contains cost estimates for technical and infrastructure upgrades to comply with BMPs.

Risk factors and monitoring for water quality to determine best management practices for splash parks.

PubMed

de Man, H; Leenen, E J T M; van Knapen, F; de Roda Husman, A M

2014-09-01

Splash parks have been associated with infectious disease outbreaks as a result of exposure to poor water quality. To be able to protect public health, risk factors were identified that determine poor water quality. Samples were taken at seven splash parks where operators were willing to participate in the study. Higher concentrations of Escherichia coli were measured in water of splash parks filled with rainwater or surface water as compared with sites filled with tap water, independent of routine inspection intervals and employed disinfection. Management practices to prevent fecal contamination and guarantee maintaining good water quality at splash parks should include selection of source water of acceptable quality.

Static and transient performance prediction for CFB boilers using a Bayesian-Gaussian Neural Network

NASA Astrophysics Data System (ADS)

Ye, Haiwen; Ni, Weidou

1997-06-01

A Bayesian-Gaussian Neural Network (BGNN) is put forward in this paper to predict the static and transient performance of Circulating Fluidized Bed (CFB) boilers. The advantages of this network over Back-Propagation Neural Networks (BPNNs), easier determination of topology, simpler and time saving in training process as well as self-organizing ability, make this network more practical in on-line performance prediction for complicated processes. Simulation shows that this network is comparable to the BPNNs in predicting the performance of CFB boilers. Good and practical on-line performance predictions are essential for operation guide and model predictive control of CFB boilers, which are under research by the authors.

Soldering and brazing safety guide: A handbook on space practice for those involved in soldering and brazing

NASA Astrophysics Data System (ADS)

This manual provides those involved in welding and brazing with effective safety procedures for use in performance of their jobs. Hazards exist in four types of general soldering and brazing processes: (1) cleaning; (2) application of flux; (3) application of heat and filler metal; and (4) residue cleaning. Most hazards during those operations can be avoided by using care, proper ventilation, protective clothing and equipment. Specific process hazards for various methods of brazing and soldering are treated. Methods to check ventilation are presented as well as a check of personal hygiene and good maintenance practices are stressed. Several emergency first aid treatments are described.

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, methods...

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 practice regulations. 210.2 Section 210.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...

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…

77 FR 71804 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-04

... Representatives on the Device Good Manufacturing Practice Advisory Committee AGENCY: Food and Drug Administration... Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological... regarding good manufacturing practices governing the methods used in, and the facilities and controls used...

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…

78 FR 16824 - Tobacco Product Manufacturing Practice; Establishment of a Public Docket

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-19

... recommendations for regulations on good manufacturing practice for tobacco products that were submitted to FDA by... performance of a tobacco product), packing, and storage of a tobacco product conform to current good... group of 13 tobacco companies submitted to FDA: (1) Recommendations for good manufacturing practice...

Training or non-surgical factors-what determines a good surgical performance? A randomised controlled trial.

PubMed

Lindlohr, Cornelia; Lefering, R; Saad, S; Heiss, M M; Pape-Köhler, C

2017-06-01

Acquiring laparoscopic skills is a necessity for every young surgeon. Whether it is a talent or a non-surgical skill that determines the surgical performance of an endoscopic operation has been discussed for years. In other disciplines aptitude testing has become the norm. Airlines, for example, have implemented assessments to test the natural aptitude of future pilots to predict their performance later on. In the medical field, especially surgery, there are no similar comparable tests implemented or even available. This study investigates the influence of potential factors that may predict the successful performance of a complex laparoscopic operation, such as the surgeon's age, gender or learning method. This study focussed 70 surgical trainees. It was designed as a secondary analysis of data derived from a 2 × 2 factorial randomised controlled trial of practical training and/or multimedia training (four groups) in an experimental exercise. Both before and then after the training sessions, the participating trainees performed a laparoscopic cholecystectomy in a pelvitrainer. Surgical performance was then evaluated using a modified objective structured assessment of technical skills (OSATS). Participants were classified as 'Skilled' (high score in the pre-test), 'Good Learner' (increase from pre- to post-test) or 'Others' based on the OSATS results. Based on the results of the recorded performance, the training methods as well as non-surgical skills were eventually evaluated in a univariate and in a multivariate analysis. In the pre-training performance 11 candidates were categorised as 'Skilled' (15.7%), 35 participants as 'Good Learners' (50.0%) and 24 participants were classified as 'Others'. The univariate analysis showed that the age, a residency in visceral surgery, and participation in a multimedia training were significantly associated with this grouping. Multivariate analyses revealed that residency in visceral surgery was the most predictive factor for the 'Skilled' participants (p = 0.059), and multimedia training was most predictive for the 'Good Learner' (p = 0.006). Participants in the group of 'Others' who were neither 'Skilled' nor improved in the training phase were younger (p = 0.011) and did not receive multimedia (p < 0.001) or practical (p = 0.025) training. The type of learning method has been shown to be the most effective factor to improve laparoscopic skills, with multimedia training proving to be more effective than practical training.

Perceptions of good medical practice in the NHS: a survey of senior health professionals.

PubMed

Hutchinson, A; Williams, M; Meadows, K; Barbour, R S; Jones, R

1999-12-01

To categorize senior health professionals' experience with poor medical practice in hospitals and in general practice, to describe perceptions which senior NHS staff have of good medical practice, and to describe how problems of poor medical practice are currently managed. A postal questionnaire survey. The questionnaire sought perceptions of good medical practice, asked participants to characterise deviations from good practice, and to describe experience with managing poor performance at the time of the introduction of the General Medical Council (GMC) performance procedures. A range of NHS settings in the UK: hospital trusts, health authorities/boards, local medical committees, community health councils. Senior health professionals involved in the management of medical professional performance. Perceptions of what constitutes good medical practice. Most respondents considered that persistent problems related to clinical practice (diagnosis, management, and outcome and prescribing) would require local management and, possibly, referral to the GMC performance procedures. Informal mechanisms, including informal discussion, education, training, and work shifting, were the most usual means of handling a doctor whose performance was poor. Many took a less serious view of deficiencies in performance on manner and attitude and communication, although consultation skills rather than technical skills comprised the greatest number of complaints about doctors. Senior NHS professionals seem reluctant to consider persistently poor consultation skills in the same critical light as they do persistently poor technical practice. These attitudes may need to change with the implementation of clinical governance and updated guidance from the GMC on what constitutes good medical practice.

Evaluation of a training program for device operators in the Australian Government's Point of Care Testing in General Practice Trial: issues and implications for rural and remote practices.

PubMed

Shephard, Mark D; Mazzachi, Beryl C; Watkinson, Les; Shephard, Anne K; Laurence, Caroline; Gialamas, Angela; Bubner, Tanya

2009-01-01

From September 2005 to February 2007 the Australian Government funded the Point of Care Testing (PoCT) in General Practice Trial, a multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost-effectiveness and satisfaction of PoCT in General Practice. In total, 53 practices (23 control and 30 intervention) based in urban, rural or remote locations across three states (South Australia [SA], New South Wales [NSW] and Victoria [VIC]) participated in the Trial. Control practices had pathology testing performed by their local laboratory, while intervention practices conducted pathology testing by PoCT. In total, 4968 patients (1958 control and 3010 intervention) participated in the Trial. The point-of-care (PoC) tests performed by intervention practices were: haemoglobin A1c (HbA1c) and urine albumin:creatinine ratio (ACR) on patients with diabetes, total cholesterol, triglyceride and high density lipoprotein (HDL) cholesterol on patients with hyperlipidaemia, and international normalised ratio (INR) on patients on anticoagulant therapy. Three PoCT devices measured these tests: the Siemens DCA 2000 (Siemens HealthCare Diagnostics, Melbourne, VIC, Australia) for HbA1c and urine ACR; Point of Care Diagnostics Cholestech LDX analyser (Point of Care Diagnostics; Sydney, NSW, Australia) for lipids; and the Roche CoaguChek S (Roche Diagnostics; Sydney, NSW, Australia) for INR. Point-of-care testing in the General Practice Trial was underpinned by a quality management framework which included an on-going training and competency program for PoCT device operators. This article describes the design, implementation and results of the training and competency program. An education and training resource package was developed for the Trial consisting of a training manual, a set of A3 laminated posters and a CD ROM. Five initial training workshops were held for intervention practices from each geographic region between August and October 2005 at three centres - Adelaide (SA), Bendigo (VIC) and Dubbo (NSW). These workshops combined theoretical training in the principles and practice of PoCT with 'hands on' practical training delivered in interactive small group sessions. At the completion of training, practice staff undertook a written and practical competency assessment and received a certificate of competency as a qualified device operator. Following each initial training workshop, practice staff completed a short satisfaction survey. Five refresher training workshops covering all geographic regions were delivered during late August 2006, coinciding with the 12 month point of the live phase of the Trial. At the completion of the Trial in February 2007, device operators completed a further questionnaire. Sixty device operators from 31 practices completed training and competency assessment as part of the Initial Training Workshop series. A further 20 device operators from 12 of the practices were trained in the 12 month period after the initial workshops; 19 of these staff were from rural or remote practices. In total 80 device operators comprising 74 practice staff and six GPs from 31 practices were trained and received competency certificates as part of Trial. In all, 19 device operators left the Trial either through personal resignation from an existing practice or because their practice withdrew from the Trial; the majority (84%) were from rural and remote practices. A total of 42 device operators from 25 practices attended refresher training in the second half of 2006. Results from the satisfaction questionnaire completed by device operators following the initial training workshops showed there was unanimous agreement that the posters were useful for the conduct of daily PoCT and practical training in small groups was satisfactory as a training method. The quality and appropriateness of the PoCT training resources and the workshop overall was rated as either good or excellent by all respondents (100% and 78%, respectively). The responses by device operators to the post-Trial satisfaction questionnaire found a high level of satisfaction with PoCT across all geographic regions. Device operators from remote practices had the highest satisfaction levels for quality of training, usefulness of the training manual, ease of use of devices, confidence in the accuracy of PoCT results and preference for PoCT over laboratory testing. The usefulness of the posters for conducting PoCT achieved the highest satisfaction rating among operators from all three geographic regions. However the highest staff turnover rates and the highest number of requests for training of additional staff were from rural and remote practices. The methods established for the implementation and delivery of training and competency assessment for the PoCT in General Practice Trial were appropriate and effective. Results of the evaluation showed rural and remote practices have a greater need for training and support compared to their urban counterparts and may require more flexible training options to cater for much higher rates of staff turnover.

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…

Good Practices for Transforming Education

ERIC Educational Resources Information Center

Benavente, Ana; Panchaud, Christine

2008-01-01

This text is a guide to the reading and interpretation of the "good practices" that are developing in the countries participating in this project and elsewhere. A systematic approach to the factors making up a "good practice" has enabled us to share our analyses in a more structured manner and to reflect on their potential for…

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 PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION...

40 CFR 86.098-23 - Required data.

Code of Federal Regulations, 2010 CFR

2010-07-01

... accordance with good engineering practice to assure that the engines covered by a certificate issued under... and conducted in accordance with good engineering practice to assure that the vehicles covered by a... systems are designed, using good engineering practice, to meet the standards of § 86.096-10 or § 86.098-11...

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…

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2012 CFR

2012-04-01

... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2010 CFR

2010-04-01

... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2011 CFR

2011-04-01

... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2013 CFR

2013-04-01

... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

Cytomegalovirus (CMV) and Pregnancy

MedlinePlus

... way to prevent infection is to practice good hygiene, particularly proper hand washing. An interventional study in ... a CMV infection found that teaching about good hygiene (and practicing good hygiene) reduced the risk of ...

Compact sensitive instrument for direct ultrasonic visualization of defects.

PubMed

Bar-Cohen, Y; Ben-Joseph, B; Harnik, E

1978-12-01

A simple ultrasonic imaging cell based on the confocal combination of a plano-concave lens and a concave spherical mirror is described. When used in conjunction with a stroboscopic schlieren visualization system, it has the main attributes of a practical nondestructive testing instrument: it is compact, relatively inexpensive, and simple to operate; its sensitivity is fair, resolution and fidelity are good; it has a fairly large field of view and a test piece can be readily scanned. The scope of its applicability is described and discussed.

Advanced Operational Aviation Medicine Course, (4th), held at Royal Air Force Institute of Aviation Medicine, Farnborough, Hampshire on 17-26 June 1975

DTIC Science & Technology

1976-05-01

possible. A life raft with an inflatable floor and a canopy provides good protection against -i chill. Frequent practice drills and experience of the...and equLpeant that will protect him from the coldl but military experience has shown that succems In such adverse onditions depends far nor* upon the...under such extreme conditions comes mainly from experience and training in that particular environmant and inKprovevents in mental and manual

Strategies for Maximizing Successful Drug Substance Technology Transfer Using Engineering, Shake-Down, and Wet Test Runs.

PubMed

Abraham, Sushil; Bain, David; Bowers, John; Larivee, Victor; Leira, Francisco; Xie, Jasmina

2015-01-01

The technology transfer of biological products is a complex process requiring control of multiple unit operations and parameters to ensure product quality and process performance. To achieve product commercialization, the technology transfer sending unit must successfully transfer knowledge about both the product and the process to the receiving unit. A key strategy for maximizing successful scale-up and transfer efforts is the effective use of engineering and shake-down runs to confirm operational performance and product quality prior to embarking on good manufacturing practice runs such as process performance qualification runs. We consider key factors to consider in making the decision to perform shake-down or engineering runs. We also present industry benchmarking results of how engineering runs are used in drug substance technology transfers alongside the main themes and best practices that have emerged. Our goal is to provide companies with a framework for ensuring the "right first time" technology transfers with effective deployment of resources within increasingly aggressive timeline constraints. © PDA, Inc. 2015.

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 manufacturing...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-01

.... FDA-1999-N-3539] (formerly Docket No. 1999N-4783) Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule... Subjects in 21 CFR Part 10 Administrative practice and procedure, News media. 0 Therefore, under the...

Monitoring clinical standards in a chronic peritoneal dialysis program.

PubMed

Leung, Dora K C

2009-02-01

Multiple factors may influence the effectiveness of a chronic peritoneal dialysis program. Continuous monitoring of various aspects of clinical standards with reviews enhances opportunities for bridging the gap between existing practice and good practice, and good practice to best practice.

16 CFR 453.4 - Required purchase of funeral goods or funeral services.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Required purchase of funeral goods or funeral services. 453.4 Section 453.4 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES FUNERAL INDUSTRY PRACTICES § 453.4 Required purchase of funeral goods or funeral services. (a) Casket for cremation provisions—(1) Unfair or...

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...) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good manufacturing practice. The criteria in §§ 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the criteria in part...

The Future of HPT Depends on Whether Practitioners Focus on Foundations or Fads

ERIC Educational Resources Information Center

Brethower, Dale M.

2012-01-01

The future of human performance technology (HPT) will be bright or dismal depending on how well HPT practitioners focus on careful and practical answers to three pivotal questions: What is good practice in human performance technology? What are the differences between good practice and bad? What are the connections between good research and…

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

Code of Federal Regulations, 2013 CFR

2013-04-01

... 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 used...

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

Code of Federal Regulations, 2014 CFR

2014-04-01

... 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 used...

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 used...

Implementing Good Practices Programs to Encourage Production of High-Quality, Safer Produce in Mississippi

ERIC Educational Resources Information Center

Mahmoud, Barakat S. M.; Stafne, Eric T.; Coker, Christine H.; Bachman, Gary R.; Bell, Nicole

2016-01-01

Fifty-four growers/producers attended four 1-day good agricultural practices (GAP) and good handling practices (GHP) workshops at four locations in Mississippi. Pre- and post workshop survey data indicated that the participants' food safety knowledge increased by 15%. Furthermore, the workshops helped producers develop their own food safety plans.…

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fiftieth report.

PubMed

2016-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Good pharmacopoeial practices; FIP-WHO technical guidelines: points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products; Guidance on good manufacturing practices for biological products; Guidance on good manufacturing practices: inspection report, including Appendix 1: Model inspection report; Guidance on good data and record management practices; Good trade and distribution practices for starting materials; Guidelines on the conduct of surveys of the quality of medicines; Collaborative procedure between the World Health Organization (WHO) prequalification team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines; Guidance for organizations performing in vivo bioequivalence studies; and World Health Organization (WHO) general guidance on variations to multisource pharmaceutical products.

Impact of the plant protection practices on the operators' exposure: survey by the communes and ministry of equipment and transport (MET-RW).

PubMed

Godeaux, D; Schiffers, B; Culot, M

2008-01-01

In order to gain a better understanding of non-agricultural pesticide use and to prepare the legislative and technical dossiers required under the Water Framework Directive, between October 2006 and March 2007, two surveys were conducted of 97 Walloon communes and 65 districts of the Walloon Ministry of Public Works and Transport (MET) (General Directorates for Motorways and Roads and for Waterway Infrastructure). The questionnaire (26 questions on six topics) was sent by e-mail or fax, with a response rate of 60 out of 97 communes and 33 out of 65 districts. This article describes the health-related aspects of the surveys (environmental aspects are the subject of separate article). The surveys have brought to light a number of bad practices and a growing awareness of the non-agricultural users with respect to health risks. However, bad habits, legislation infringements and a failure to follow good plant protection practice are still a problem and pose major health risks (which endanger the operator and the public). Information, awareness-raising and, especially, training of people therefore remain a priority for non-agricultural users.

Good governance in national solid waste management policy (NSWMP) implementation: A case study of Malaysia

NASA Astrophysics Data System (ADS)

Wee, Seow Ta; Abas, Muhamad Azahar; Mohamed, Sulzakimin; Chen, Goh Kai; Zainal, Rozlin

2017-10-01

The National Solid Waste Management Policy (NSWMP) was introduced in 2007 under the Act 672. The execution of NSWMP involves stakeholders from various government agencies and a collaboration with the private sectors. Despite the initiatives taken by the stakeholders, the objectives of NSWMP failed to materialise. One of the major constraints is weak governance among stakeholders with regards to the NSWMP implementation. This paper will explore the good governance practices implemented by the stakeholders. Identifying the current good governance practices implemented by the stakeholders is crucial as it will serve as a guideline to improve good governance practice in the future. An exploratory research approach is applied in this study through in-depth interviews with several government agencies and concessionaires involved in the NSWMP implementation. A total of six respondents took part in this study. The findings of this study show that there are several good governance practices implemented in policy promotion, participation of stakeholders, and capacity enhancement programme for the staff. This study also proposed some points on good governance practices in the context of policy promotion and staff development. A paradigm shift by the stakeholders is imperative so as to enhance the good governance practice in NSWMP implementation towards an efficient solid waste management in Malaysia.

Knowledge and Preventive Practices related to Avian Influenza among Poultry Workers of Kamalamai Municipality, Sindhuli, Nepal.

PubMed

Shrestha, R; Shrestha, K B; Ghimire, S; Shrestha, N

2016-01-01

Avian influenza (AI) is currently a threat to global health. Prevention and control of AI depends on the knowledge and preventive practices of the poultry workers as well as of general population. This study aims to assess knowledge and preventive practices related to AI among poultry workers. Cross-sectional study was carried out among poultry workers of Kamalamai Municipality, Sindhuli. Data was collected from randomly selected 122 respondents through face-to-face interview. The collected data was entered in Epi-data version 3.1 and analyzed in terms of descriptive statistics (proportion, 95% CI, mean and standard deviation) by using SPSS, version 20. A scoring system was used to assess knowledge and preventive practices. Out of total, 93.4% (95% CI, 87.6- 96.6%) of the respondents had heard about AI. More than half (54.9%) of the respondents had poor knowledge on AI. Only 5.3% of respondents had good preventive practice against AI. 30.3% respondents had good knowledge and good practice and 24.6% had poor knowledge as well as poor practice. 20.5% of the respondents had good practice but poor knowledge, whereas, 24.6% had good knowledge but poor practice towards prevention. The knowledge and practice of AI among poultry workers were low. The groups should be targeted for appropriate intervention based on whether they lack knowledge or practice or both.

Potential sources of microbial contamination in unpasteurized apple cider.

PubMed

Garcia, Luis; Henderson, John; Fabri, Martha; Oke, Moustapha

2006-01-01

A study was conducted to identify possible sources of microbial contamination and to assess the effect of good cleaning and sanitation practices on the microbial quality and safety of unpasteurized apple cider. Raw unwashed apples, washed apples, cleaning water, fresh cider, and finished cider samples were collected from five Ontario producers over 4 months and microbiologically tested. Total coliforms were found in 31, 71 and 38% of the unwashed apple, water, and washed apple samples, respectively. Escherichia coli was found in 40% of the water samples from one producer alone. The washing step was identified as a potential source of contamination, possibly due to water in the dump tanks seldom being refreshed, and because scrubbers, spray nozzles, and conveyors were not properly cleaned and sanitized. Higher total coliform counts (P < 0.0001) and prevalence (P < 0.0001) in fresh cider compared with those in unwashed apples and washed apples indicated considerable microbial buildup along the process, possibly explained by the lack of appropriate equipment sanitation procedures. Results showed that producers who had better sanitary practices in place had lower (P < 0.001) total coliform prevalence than the rest of the producers. Overall results show that good sanitation procedures are associated with improved microbial quality of fresh cider in terms of total coliforms and that operators who pasteurize and/or UV treat their product should still be required to have a sound good manufacturing practices program in place to prevent recontamination. Cryptosporidium parvum, an important pathogen for this industry, was found in different sample types, including washed apples, water, and fresh and finished cider.

[New approach for managing microbial risks in food].

PubMed

Augustin, Jean-Christophe

2015-01-01

The aim of the food legislation is to ensure the protection of human health. Traditionally, the food legislation requires food business operators to apply good hygiene practices and specific procedures to control foodborne pathogens. These regulations allowed reaching a high level of health protection. The improvement of the system will require risk-based approaches. Firstly, risk assessment should allow the identification of high-risk situations where resources should be allocated for a better targeting of risk management. Then, management measures should be adapted to the health objective. In this approach, the appropriate level of protection is converted intofood safety and performance objectives on the food chain, i.e., maximum microbial contamination to fulfil the acceptable risk level. When objectives are defined, the food business operators and competent authorities can identify control options to comply with the objectives and establish microbiological criteria to verify compliance with these objectives. This approach, described for approximately 10 years, operative thanks to the development of quantitative risk assessment techniques, is still difficult to use in practical terms since it requires a commitment of competent authorities to define the acceptable risk and needs also the implementation of sometimes complex risk models.

Good Practice and Recommendations for Research Team Leadership

DTIC Science & Technology

2017-05-01

ARL-SR-0372 ● MAY 2017 US Army Research Laboratory Good Practice and Recommendations for Research Team Leadership by Mark L...Do not return it to the originator. ARL-SR-0372 ● MAY 2017 US Army Research Laboratory Good Practice and Recommendations for...information, including suggestions for reducing the burden, to Department of Defense, Washington Headquarters Services , Directorate for Information

Impacts of Good Practices on Cognitive Development, Learning Orientations, and Graduate Degree Plans during the First Year of College

ERIC Educational Resources Information Center

Cruce, Ty M.; Wolniak, Gregory C.; Seifert, Tricia A.; Pascarella, Ernest T.

2006-01-01

This study estimated separately the unique effects of three dimensions of good practice and the global effects of a composite measure of good practices on the cognitive development, orientations to learning, and educational aspirations of students during their first year of college. Analyses of longitudinal data from a representative sample of…

Knowledge for the good of the individual and society: linking philosophy, disciplinary goals, theory, and practice.

PubMed

McCurry, Mary K; Revell, Susan M Hunter; Roy, Sr Callista

2010-01-01

Nursing as a profession has a social mandate to contribute to the good of society through knowledge-based practice. Knowledge is built upon theories, and theories, together with their philosophical bases and disciplinary goals, are the guiding frameworks for practice. This article explores a philosophical perspective of nursing's social mandate, the disciplinary goals for the good of the individual and society, and one approach for translating knowledge into practice through the use of a middle-range theory. It is anticipated that the integration of the philosophical perspective and model into nursing practice will strengthen the philosophy, disciplinary goal, theory, and practice links and expand knowledge within the discipline. With the focus on humanization, we propose that nursing knowledge for social good will embrace a synthesis of the individual and the common good. This approach converges vital and agency needs described by Hamilton and the primacy of maintaining the heritage of the good within the human species as outlined by Maritain. Further, by embedding knowledge development in a changing social and health care context, nursing focuses on the goals of clinical reasoning and action. McCubbin and Patterson's Double ABCX Model of Family Adaptation was used as an example of a theory that can guide practice at the community and global level. Using the theory-practice link as a foundation, the Double ABCX model provides practising nurses with one approach to meet the needs of individuals and society. The integration of theory into nursing practice provides a guide to achieve nursing's disciplinary goals of promoting health and preventing illness across the globe. When nursing goals are directed at the synthesis of the good of the individual and society, nursing's social and moral mandate may be achieved.

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

PubMed

Sivris, Kelly C; Leka, Stavroula

2015-12-01

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. 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. 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. 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.

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

12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 1780.7 - Good faith certification.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 7 2011-01-01 2011-01-01 false Good faith certification. 1780.7 Section 1780.7... DEVELOPMENT RULES OF PRACTICE AND PROCEDURE RULES OF PRACTICE AND PROCEDURE General Rules § 1780.7 Good faith... record is well-grounded in fact and is warranted by existing law or a good faith, nonfrivolous argument...

12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 4 2014-01-01 2014-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 3 2011-01-01 2011-01-01 false Good faith certification. 263.7 Section 263.7... RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith certification... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 4 2013-01-01 2013-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 5 2012-01-01 2012-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 4 2012-01-01 2012-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 4 2011-01-01 2011-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 308.7 - Good faith certification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

12 CFR 1780.7 - Good faith certification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Good faith certification. 1780.7 Section 1780.7... DEVELOPMENT RULES OF PRACTICE AND PROCEDURE RULES OF PRACTICE AND PROCEDURE General Rules § 1780.7 Good faith... record is well-grounded in fact and is warranted by existing law or a good faith, nonfrivolous argument...

12 CFR 263.7 - Good faith certification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Good faith certification. 263.7 Section 263.7... RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith certification... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

"Co-operation in All Human Endeavour": quarantine and immigrant disease vectors in the 1918-1919 influenza pandemic in Winnipeg.

PubMed

Jones, Esyllt W

2005-01-01

Unlike occurrences of other contagious diseases such as cholera and smallpox, the 1918-19 influenza pandemic did not lead to anti-immigrant backlash, the stigmatization of newcomers as disease carriers, or aggressive quarantine measures focused against immigrant groups. During influenza outbreaks in several major Canadian cities, quarantine was either rejected or was a low-priority containment measure, reluctantly and sceptically employed. Blaming immigrants during the epidemic was not considered enlightened public health practice or good disease containment strategy. Retrospective evaluation of the successes and failures of the fight against influenza concluded that coercive measures such as quarantine did more harm than good. The experience with influenza contributed to new notions of immigrant inclusion in the social body.

Simulation of changes on the psychosocial risk in the nursing personnel after implementing the policy of good practices on the risk treatment.

PubMed

Bolívar Murcia, María Paula; Cruz González, Joan Paola; Rodríguez Bello, Luz Angélica

2018-02-01

Evaluate the change over time of psychosocial risk management for the nursing personnel of an intermediate complexity clinic of Bogota (Colombia). Descriptive and correlational research performed under the approach of risk management (identification, analysis, assessment and treatment). The psychosocial risk of the nursing personnel was studied through 10-year system dynamics models (with and without the implementation of the policy of good practices on the risk treatment) in two scenarios: when the nursing personnel works shifts of 6 hours (morning or afternoon) and when they work over 12 hours (double shift or night shift). When implementing a policy of good practices on the risk treatment, the double shift scenario shows an improvement among 25% to 88% in the variables of: health, labor motivation, burnout, service level and productivity; as well as in the variables of the organization associated to number of patients, nursing personnel and profit. Likewise, the single shift scenario with good practices improves in all the above-mentioned variables and generates stability on the variables of absenteeism and resignations. The best scenario is the single shift scenario with the application of good practices of risk treatment in comparison with the double shift scenario with good practices, which allows concluding that the good practices have a positive effect on the variables of nursing personnel and on those associated to the organization. Copyright© by the Universidad de Antioquia.

European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of multifocal motor neuropathy.

PubMed

van Schaik, I N; Bouche, P; Illa, I; Léger, J-M; Van den Bergh, P; Cornblath, D R; Evers, E M A; Hadden, R D M; Hughes, R A C; Koski, C L; Nobile-Orazio, E; Pollard, J; Sommer, C; van Doorn, P A

2006-08-01

Several diagnostic criteria for multifocal motor neuropathy have been proposed in recent years and a beneficial effect of intravenous immunoglobulin (IVIg) and various other immunomodulatory drugs has been suggested in several trials and uncontrolled studies. The objectives were to prepare consensus guidelines on the definition, investigation and treatment of multifocal motor neuropathy. Disease experts and a patient representative considered references retrieved from MEDLINE and the Cochrane Library in July 2004 and prepared statements which were agreed in an iterative fashion. The Task Force agreed good practice points to define clinical and electrophysiological diagnostic criteria for multifocal motor neuropathy and investigations to be considered. The principal recommendations and good practice points were: (i) IVIg (2 g/kg given over 2-5 days) should be considered as the first line treatment (level A recommendation) when disability is sufficiently severe to warrant treatment. (ii) Corticosteroids are not recommended (good practice point). (iii) If initial treatment with IVIg is effective, repeated IVIg treatment should be considered (level C recommendation). The frequency of IVIg maintenance therapy should be guided by the individual response (good practice point). Typical treatment regimens are 1 g/kg every 2-4 weeks or 2 g/kg every 4-8 weeks (good practice point). (iv) If IVIg is not or not sufficiently effective then immunosuppressive treatment may be considered. Cyclophosphamide, ciclosporin, azathioprine, interferon beta1a, or rituximab are possible agents (good practice point). (v) Toxicity makes cyclophosphamide a less desirable option (good practice point).

7 CFR 1437.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... (including ornamental fish), and floriculture, an environment in which everything that can practicably be..., as determined by CCC. Good farming practices means the cultural practices generally used for the crop... good farming practices. T-Yield means the yield which is based on the county expected yield of the crop...

Enterobacteriaceae Antibiotic Resistance in Ready-to-Eat Foods Collected from Hospital and Community Canteens: Analysis of Prevalence.

PubMed

Vincenti, Sara; Raponi, Matteo; Sezzatini, Romina; Giubbini, Gabriele; Laurenti, Patrizia

2018-03-01

Foodborne diseases and antibiotic resistance are serious widespread health problems in the contemporary world. In this study, we compared the microbiological quality of ready-to-eat (RTE) foods found in community canteens versus hospital canteens in Rome, Italy, focusing on detection and quantification of Enterobacteriaceae and the antibiotic resistance of these bacteria. Our findings show a remarkable difference in Enterobacteriaceae contamination between RTE foods distributed in community canteens (33.5% of samples) and those distributed in hospital canteens (5.3% of samples). This result highlights greater attention to good manufacturing practices and good hygiene practices by the food operators in hospitals compared with food operators in community canteens. As expected, a higher percentage of cold food samples (70.9%) than of hot food samples (10.8%) were positive for these bacteria. Excluding the intrinsic resistance of each bacterial strain, 92.3% of the isolated strains were resistant to at least one antibiotic, and about half of the isolated strains were classified as multidrug resistant. The prevalence of multidrug-resistant strains was 50% in the community samples and 33.3% in hospital canteens. Our results indicate that approximately 38% of RTE foods provided in community canteens is not compliant with microbiological food safety criteria and could be a special risk for consumers through spread of antibiotic-resistant strains. Hygienic processing and handling of foods is necessary for both hospital and community canteens.

Establishment and operation of a Good Manufacturing Practice-compliant allogeneic Epstein-Barr virus (EBV)-specific cytotoxic cell bank for the treatment of EBV-associated lymphoproliferative disease.

PubMed

Vickers, Mark A; Wilkie, Gwen M; Robinson, Nicolas; Rivera, Nadja; Haque, Tanzina; Crawford, Dorothy H; Barry, Jacqueline; Fraser, Neil; Turner, David M; Robertson, Victoria; Dyer, Phil; Flanagan, Peter; Newlands, Helen R; Campbell, John; Turner, Marc L

2014-11-01

Epstein-Barr virus (EBV) is associated with several malignancies, including post-transplant lymphoproliferative disorder (PTLD). Conventional treatments for PTLD are often successful, but risk organ rejection and cause significant side effects. EBV-specific cytotoxic T lymphocytes (CTLs) generated in vitro from peripheral blood lymphocytes provide an alternative treatment modality with few side effects, but autologous CTLs are difficult to use in clinical practice. Here we report the establishment and operation of a bank of EBV-specific CTLs derived from 25 blood donors with human leucocyte antigen (HLA) types found at high frequency in European populations. Since licensure, there have been enquiries about 37 patients, who shared a median of three class I and two class II HLA types with these donors. Cells have been infused into ten patients with lymphoproliferative disease, eight of whom achieved complete remission. Neither patient with refractory disease was matched for HLA class II. Both cases of EBV-associated non-haematopoietic sarcoma receiving cells failed to achieve complete remission. Thirteen patients died before any cells could be issued, emphasizing that the bank should be contacted before patients become pre-terminal. Thus, this third party donor-derived EBV-specific CTL cell bank can supply most patients with appropriately matched cells and most recipients have good outcomes. © 2014 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.

Solvent-free enzymatic synthesis of 1, 3-Diacylglycerols by direct esterification of glycerol with saturated fatty acids

PubMed Central

2013-01-01

Background Pure 1, 3-diacylglycerols (1, 3-DAG) have been considered to be significant surfactants in food, cosmetics and pharmaceutical industries, as well as the effect on obesity prevention. Methods In this study, a vacuum-driven air bubbling operation mode was developed and evaluated for the enzymatic synthesis of 1, 3-DAG of saturated fatty acids, by direct esterification of glycerol with fatty acids in a solvent-free system. The employed vacuum-driven air bubbling operation mode was comparable to vacuum-driven N2 bubbling protocol, in terms of lauric acid conversion and 1, 3-dilaurin content. Results Some operation parameters were optimized, and 95.3% of lauric acid conversion and 80.3% of 1, 3-dilaurin content was obtained after 3-h reaction at 50°C, with 5 wt% of Lipozyme RM IM (based on reactants) amount. Of the lipases studied, both Lipozyme RM IM and Novozym 435 exhibited good performance in terms of lauric acid conversion. Lipozyme TL IM, however, showed low activity. Lipozyme RM IM showed good operational stability in this operation protocol, 80.2% of the original catalytic activity remained after 10 consecutive batch applications. Some other 1, 3-DAG were prepared and high content was obtained after purification: 98.5% for 1, 3-dicaprylin, 99.2% for 1, 3-dicaprin, 99.1% for 1, 3-dilaurin, 99.5 for 1, 3-dipalmitin and 99.4% for 1, 3-disterin. Conclusion The established vacuum-driven air bubbling operation protocol had been demonstrated to be a simple-operating, cost-effective, application practical and efficient methodology for 1, 3-DAG preparation. PMID:23656739

Laboratory considerations of United States Pharmacopeia Chapter <71> sterility tests and its application to pharmaceutical compounding.

PubMed

Hyde, Tiffany D

2014-01-01

The purpose of this article is to describe United States Pharmacopeia Chapter <71> Sterility Tests from the perspective of Current Good Manufacturing Practices in order to aid compounding pharmacists in understanding the details and complexities that are required. Compounding pharmacists face a unique challenge in the industry today, with their compounding practice and the U.S. Food and Drug Administration trying to impose Current Good Manufacturing Practices guidelines. Naturally, this becomes a challenge to contract testing laboratories as well, as they are caught between the testing for non-Current Good Manufacturing Practices compounding standards and Current Good Manufacturing Practices manufacturing. It is important that the compounding pharmacist and their partner testing laboratory work closely together to ensure appropriate requirements are being met.

Estimation of pollutant loads considering dam operation in Han River Basin by BASINS/Hydrological Simulation Program-FORTRAN.

PubMed

Jung, Kwang-Wook; Yoon, Choon-G; Jang, Jae-Ho; Kong, Dong-Soo

2008-01-01

Effective watershed management often demands qualitative and quantitative predictions of the effect of future management activities as arguments for policy makers and administration. The BASINS geographic information system was developed to compute total maximum daily loads, which are helpful to establish hydrological process and water quality modeling system. In this paper the BASINS toolkit HSPF model is applied in 20,271 km(2) large watershed of the Han River Basin is used for applicability of HSPF and BMPs scenarios. For proper evaluation of watershed and stream water quality, comprehensive estimation methods are necessary to assess large amounts of point source and nonpoint-source (NPS) pollution based on the total watershed area. In this study, The Hydrological Simulation Program-FORTRAN (HSPF) was estimated to simulate watershed pollutant loads containing dam operation and applied BMPs scenarios for control NPS pollution. The 8-day monitoring data (about three years) were used in the calibration and verification processes. Model performance was in the range of "very good" and "good" based on percent difference. The water-quality simulation results were encouraging for this large sizable watershed with dam operation practice and mixed land uses; HSPF proved adequate, and its application is recommended to simulate watershed processes and BMPs evaluation. IWA Publishing 2008.

[What everybody should know about good clinical practices].

PubMed

Osorio, Lyda

2015-01-01

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.

16 CFR 301.48a - Guaranties not received in good faith.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Guaranties not received in good faith. 301.48a Section 301.48a Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF... received in good faith. A guaranty shall not be deemed to have been received in good faith within the...

16 CFR 301.48a - Guaranties not received in good faith.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Guaranties not received in good faith. 301.48a Section 301.48a Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF... received in good faith. A guaranty shall not be deemed to have been received in good faith within the...

16 CFR 301.48a - Guaranties not received in good faith.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Guaranties not received in good faith. 301.48a Section 301.48a Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF... received in good faith. A guaranty shall not be deemed to have been received in good faith within the...

16 CFR 301.48a - Guaranties not received in good faith.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Guaranties not received in good faith. 301.48a Section 301.48a Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF... received in good faith. A guaranty shall not be deemed to have been received in good faith within the...

Design of sewage treatment system by applying fuzzy adaptive PID controller

NASA Astrophysics Data System (ADS)

Jin, Liang-Ping; Li, Hong-Chan

2013-03-01

In the sewage treatment system, the dissolved oxygen concentration control, due to its nonlinear, time-varying, large time delay and uncertainty, is difficult to establish the exact mathematical model. While the conventional PID controller only works with good linear not far from its operating point, it is difficult to realize the system control when the operating point far off. In order to solve the above problems, the paper proposed a method which combine fuzzy control with PID methods and designed a fuzzy adaptive PID controller based on S7-300 PLC .It employs fuzzy inference method to achieve the online tuning for PID parameters. The control algorithm by simulation and practical application show that the system has stronger robustness and better adaptability.

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

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2011-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

Variable implementation of good practice recommendations for the assessment and management of UK children with neurodisability.

PubMed

Gray, L; Gibbs, J; Jolleff, N; Williams, J; McConachie, H; Parr, J R

2015-11-01

The aims of this study were to determine whether UK child development teams (CDTs) have implemented good practice recommendations for the co-ordinated assessment and support of children with neurodisability and to explore some of the factors associated with variations in good practice implementation. Surveys were sent to every UK CDT in 2009/2010. Responses about CDT provision and ways of working were compared with good practice recommendations from national policy documents and professional organizations. The extent to which CDTs in England and Wales met 11 selected good practice recommendations was scored; teams in Scotland and Northern Ireland were given a score out of 9 to reflect the optional use of the common assessment framework and early support materials in these countries. Responses were received from 225/240 (94%) UK CDTs. Thirty-seven per cent of CDTs in England and Wales had implemented nine or more of the 11 recommendations. Fifty-nine per cent of teams in Scotland and 78% of teams in Northern Ireland met between six and nine recommendations of good working practice. Higher levels of implementation of recommendations were found when the CDT had a Child Development Centre base and for teams who had received increased funding in the 5 years preceding the survey. There was considerable variability in the degree to which CDTs implemented good practice recommendations for the diagnosis and management of children with neurodisability. Evidence about child and parent satisfaction, and the effectiveness of CDT practices and provision, is required, so policymakers, healthcare commissioners and clinicians can provide the most appropriate services to children with neurodisability and their families. © 2015 John Wiley & Sons Ltd.

9 CFR 149.1 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... generates a written record documenting a pork production site's adherence to the required good production... production site for compliance with good production practices and other program requirements of the Trichinae... or higher, based on adherence to good production practices and other program requirements as provided...

9 CFR 149.1 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... generates a written record documenting a pork production site's adherence to the required good production... production site for compliance with good production practices and other program requirements of the Trichinae... or higher, based on adherence to good production practices and other program requirements as provided...

Diabetes and Diabetic Retinopathy: Knowledge, Attitude, Practice (KAP) among Diabetic Patients in A Tertiary Eye Care Centre

PubMed Central

Srinivasan, Nithin Keshav; John, Deepa; Rebekah, Grace; Kujur, Evon Selina; Paul, Padma

2017-01-01

Introduction Diabetic retinopathy is becoming an increasingly important cause of visual impairment in India. Many diabetic patients who come to our centre have undetected, advanced diabetic retinopathy. If diabetic retinopathy had been detected earlier in these patients, irreversible visual impairment could have been prevented. Aim To document Knowledge, Attitude and Practice (KAP) patterns of diabetic patients regarding diabetes and diabetic retinopathy, to determine association between them, and to identify barriers to compliance with follow up and treatment regimes. Materials and Methods This was a hospital-based, cross-sectional study, conducted at the Department of Ophthalmology at Christian Medical College, Vellore, Tamil Nadu, India, over a six-month period from June 2013 to November 2013. Two hundred and eighty eight diabetic patients, who fulfilled the eligibility criteria, were included in the study. KAP of patients was assessed using a 45-point, verbally administered questionnaire. Patients were placed in different categories, such as, ‘good/ poor’ knowledge, ‘positive/negative’ attitude and ‘good/poor’ practice. Data were analysed using Chi-square test and binary logistic regression, as appropriate. The proportion of patients with ‘good/poor’ knowledge, ‘positive/negative’ attitude and ‘good/poor’ practice, and the association between KAP were studied. Barriers to compliance with follow up/treatment regimes were identified. Results Out of the 288 patients in the study, 42% had good knowledge about diabetes, but only 4.5% had good knowledge about retinopathy. Good knowledge about diabetes was significantly associated with positive attitude towards diabetes and good practice patterns regarding retinopathy; awareness of retinopathy was also significantly associated with good practice. A total of 61.1% of patients did not have periodic eye examination; most common barrier identified was lack of awareness about the necessity for this (38.5%). Conclusion Good knowledge about the disease was significantly associated with positive attitude and good practice patterns. Knowledge about diabetic retinopathy was poor among the patients in our study. Lack of awareness concerning the need for screening for retinopathy was a major barrier to regular screening. There is an urgent need to educate diabetic patients about this potentially blinding complication of diabetes. PMID:28892947

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…

CHRODIS criteria applied to the MASK (MACVIA-ARIA Sentinel NetworK) Good Practice in allergic rhinitis: a SUNFRAIL report.

PubMed

Bousquet, J; Onorato, G L; Bachert, C; Barbolini, M; Bedbrook, A; Bjermer, L; de Sousa, J Correia; Chavannes, N H; Cruz, A A; De Manuel Keenoy, E; Devillier, P; Fonseca, J; Hun, S; Kostka, T; Hellings, P W; Illario, M; Ivancevich, J C; Larenas-Linnemann, D; Millot-Keurinck, J; Ryan, D; Samolinski, B; Sheikh, A; Yorgancioglu, A; Agache, I; Arnavielhe, S; Bewick, M; Annesi-Maesano, I; Anto, J M; Bergmann, K C; Bindslev-Jensen, C; Bosnic-Anticevich, S; Bouchard, J; Caimmi, D P; Camargos, P; Canonica, G W; Cardona, V; Carriazo, A M; Cingi, C; Colgan, E; Custovic, A; Dahl, R; Demoly, P; De Vries, G; Fokkens, W J; Fontaine, J F; Gemicioğlu, B; Guldemond, N; Gutter, Z; Haahtela, T; Hellqvist-Dahl, B; Jares, E; Joos, G; Just, J; Khaltaev, N; Keil, T; Klimek, L; Kowalski, M L; Kull, I; Kuna, P; Kvedariene, V; Laune, D; Louis, R; Magnan, A; Malva, J; Mathieu-Dupas, E; Melén, E; Menditto, E; Morais-Almeida, M; Mösges, R; Mullol, J; Murray, R; Neffen, H; O'Hehir, R; Palkonen, S; Papadopoulos, N G; Passalacqua, G; Pépin, J L; Portejoie, F; Price, D; Pugin, B; Raciborski, F; Simons, F E R; Sova, M; Spranger, O; Stellato, C; Todo Bom, A; Tomazic, P V; Triggiani, M; Valero, A; Valovirta, E; VandenPlas, O; Valiulis, A; van Eerd, M; Ventura, M T; Wickman, M; Young, I; Zuberbier, T; Zurkuhlen, A; Senn, A

2017-01-01

A Good Practice is a practice that works well, produces good results, and is recommended as a model. MACVIA-ARIA Sentinel Network (MASK), the new Allergic Rhinitis and its Impact on Asthma (ARIA) initiative, is an example of a Good Practice focusing on the implementation of multi-sectoral care pathways using emerging technologies with real life data in rhinitis and asthma multi-morbidity. The European Union Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS) has developed a checklist of 28 items for the evaluation of Good Practices. SUNFRAIL (Reference Sites Network for Prevention and Care of Frailty and Chronic Conditions in community dwelling persons of EU Countries), a European Union project, assessed whether MASK is in line with the 28 items of JA-CHRODIS. A short summary was proposed for each item and 18 experts, all members of ARIA and SUNFRAIL from 12 countries, assessed the 28 items using a Survey Monkey-based questionnaire. A visual analogue scale (VAS) from 0 (strongly disagree) to 100 (strongly agree) was used. Agreement equal or over 75% was observed for 14 items (50%). MASK is following the JA-CHRODIS recommendations for the evaluation of Good Practices.

Tools to share good chairside teaching practice: a clinical scenario and appreciative questionnaire.

PubMed

Sweet, J; Wilson, J; Pugsley, L; Schofield, M

2008-12-13

This article provides a scenario for analysis of good chairside teaching practice to serve as a starting point for continued discussion in this complex field. Documented issues of good chairside teaching practice are cross-referenced to a clinical scenario with explanations in the form of a commentary. This provided the context for generating a set of questions that are provided as tools to support good chairside practice. These tools are designed to be used with 'Appreciative Inquiry', which claims that there is much to be gained by discovering where excellence is possible and elaborating upon this. Although this process can be carried out in single units or departments, it is proposed that collaboration between institutions would allow sharing of valuable innovations and greater understanding of educational training, production of good practice guidance and professional development of staff. This article is the third in a series of three and provides a scaffold for a scenario and questions to encourage collaboration in evolving and sharing good chairside teaching practice. The first article investigated the perceptions of stakeholders in chairside teaching at a single dental school and the second evaluated chairside teaching on a UK wide scale. A further accompanying article reviews some of the educational methodology and innovations in teaching and learning that may be applied to dentistry.

76 FR 24291 - Proposed National Marketing Agreement Regulating Leafy Green Vegetables; Recommended Decision and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-29

... Practices (GAPs) and Good Manufacturing Practices (GMPs), and United States Department of Agriculture (USDA) Good Handling Practices (GHPs). The program would be voluntary, and cover both United States and... referred to as the ``Act'', and the applicable rules of practice and procedure governing the formulation of...

Operating room myths: what is the evidence for common practices.

PubMed

Pada, Surinder; Perl, Trish M

2015-08-01

In order to ensure patient safety and prevent surgical site infections (SSIs), operating theaters/rooms have evolved into complex, highly technical environments. Prevention of healthcare-associated infections, and strategies to limit patient harm, have gained momentum over the last decade. This article aims to examine and dispute some commonly held beliefs with specific reference to: laminar airflow, noise and operating theater door openings and how these impact SSI. Laminar airflow may not be necessary for prosthetic implant surgery. Some recent data suggest that there may be patient harm. With the development of better surgical techniques and perioperative care, such costly systems may not be needed. Operating rooms with a high number of door openings have also been shown to experience higher SSI rates, as have operating rooms with high noise levels. These may serve as surrogate markers for operating room discipline. Initiatives which target these areas may be worth considering when devising strategies to reduce SSIs. Improved surveillance systems for SSIs are needed and should include operating theater airflow type. This will allow further analysis of the effect of laminar air flow on SSIs and provide evidence for a decisive recommendation. Cultivating a culture of good operating theater discipline may also reduce SSIs.

Quality Interaction Between Mission Assurance and Project Team Members

NASA Technical Reports Server (NTRS)

Kwong-Fu, Helenann H.; Wilson, Robert K.

2006-01-01

Mission Assurance independent assessments started during the development cycle and continued through post launch operations. In operations, Health and Safety of the Observatory is of utmost importance. Therefore, Mission Assurance must ensure requirements compliance and focus on process improvements required across the operational systems including new/modified products, tools, and procedures. The deployment of the interactive model involves three objectives: Team member Interaction, Good Root Cause Analysis Practices, and Risk Assessment to avoid reoccurrences. In applying this model, we use a metric based measurement process and was found to have the most significant effect, which points to the importance of focuses on a combination of root cause analysis and risk approaches allowing the engineers the ability to prioritize and quantify their corrective actions based on a well-defined set of root cause definitions (i.e. closure criteria for problem reports), success criteria and risk rating definitions.

Surviving self-employment: a personal case history.

PubMed

Kasnot, K

1993-01-01

In the popular perception of what determines one's success as a free-lance illustrator, issues other than natural talent or artistic ability are seldom emphasized. In addition to a firm philosophical foundation and a good work ethic, the organization and management of practical concerns play significant roles in the successful operation of any free-lance business. Presented as a personal history, this article discusses some of the most important, yet most neglected, issues that are essential to the economic security and survival of anyone considering a career as a free-lance illustrator.

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

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.

Long-Wavelength 640 x 486 GaAs/AlGaAs Quantum Well Infrared Photodetector Snap-Shot Camera

NASA Technical Reports Server (NTRS)

Gunapala, Sarath D.; Bandara, Sumith V.; Liu, John K.; Hong, Winn; Sundaram, Mani; Maker, Paul D.; Muller, Richard E.; Shott, Craig A.; Carralejo, Ronald

1998-01-01

A 9-micrometer cutoff 640 x 486 snap-shot quantum well infrared photodetector (QWIP) camera has been demonstrated. The performance of this QWIP camera is reported including indoor and outdoor imaging. The noise equivalent differential temperature (NE.deltaT) of 36 mK has been achieved at 300 K background with f/2 optics. This is in good agreement with expected focal plane array sensitivity due to the practical limitations on charge handling capacity of the multiplexer, read noise, bias voltage, and operating temperature.

NEUTRON RADIATION DAMAGE IN CCD CAMERAS AT JOINT EUROPEAN TORUS (JET).

PubMed

Milocco, Alberto; Conroy, Sean; Popovichev, Sergey; Sergienko, Gennady; Huber, Alexander

2017-10-26

The neutron and gamma radiations in large fusion reactors are responsible for damage to charged couple device (CCD) cameras deployed for applied diagnostics. Based on the ASTM guide E722-09, the 'equivalent 1 MeV neutron fluence in silicon' was calculated for a set of CCD cameras at the Joint European Torus. Such evaluations would be useful to good practice in the operation of the video systems. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2012 CFR

2012-04-01

....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2013 CFR

2013-04-01

....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2011 CFR

2011-04-01

....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

21 CFR 184.1452 - Manganese gluconate.

Code of Federal Regulations, 2010 CFR

2010-04-01

....1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

Knowledge and practice of tuberculosis infection control among health professionals in Northwest Ethiopia; 2011.

PubMed

Temesgen, Chanie; Demissie, Meaza

2014-11-19

Tuberculosis (TB) is highly prevalent in sub-Saharan Africa, making the risk of infection transmission high in these countries. Despite high prevalence of TB and expected high probability of nosocomial transmission in Ethiopia, a rapid assessment done in 2008 revealed that most health facilities in Ethiopia do not use tuberculosis infection control (TBIC) practices. Patients and providers are therefore at risk of exposure to TB, especially at high case load facilities. The purpose of this study was to assess TBIC knowledge and practices among health professionals working in hospitals in the Amhara region of Northwest Ethiopia. An institution-based hybrid study was implemented form August 2010 to January 2011. The subjects were health professionals who were proportionally selected from each hospital. Subjects self-administered a questionnaire that contained sections on socio-demographics and on TBIC knowledge and practice. Those answering ≥60% of knowledge questions correctly and ≥50% of practice questions correctly were considered to have good knowledge and practice, respectively. A total of 313 healthcare professionals were enrolled from four healthcare facilities. The response rate was 96%. Only 18.8% received in-service training. Among those who were trained, 74.4%, 95% CI (69.6, 79.3%) were found to have good knowledge and 63.2%, 95% CI (57.9, 68.6%) good practice on TBIC. Training was found to be a predictor of TBIC knowledge, AOR* 3.386 and 95% CI (1.377, 8.330) while knowledge of TBIC was a strong predictor of good TBIC practice, AOR* 10.667 and 95% CI (5.769, 19.721). Though the majority of the respondents had good TBIC knowledge and practice, a considerable proportion of healthcare professionals were not trained on TBIC. Respondents trained on TBIC were found to be more knowledgeable than those not trained. Similarly, respondents with good TBIC knowledge were 10 times more likely to have good TBIC practice compared to those with poor TBIC knowledge. Training was not found to have an effect on TBIC practice. *Adjusted Odds Ratio.

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…

Operational effectiveness of blended e-learning program for nursing research ethics.

PubMed

Cho, Kap-Chul; Shin, Gisoo

2014-06-01

Since 2006, the Korean Ministry of Education, Science and Technology, and the National Research Foundation of Korea have taken the lead in developing an institutional guideline for research ethics. The purpose was to identify the effectiveness of the Good Research Practice program, developed on a fund granted by the National Research Foundation of Korea, for nurses and nursing students whose knowledge and perception of research ethics were compared before and after the implementation of the Good Research Practice program. This study was conducted to compare the levels of knowledge and perception of research ethics in the participants before and after the program was implemented. The participants included 45 nurses and 69 nursing students from hospitals, colleges of nursing, and the Korean Nurses Association, located in Seoul, Korea. This study was approved by the Institutional Research Board in Korea. Based on the Analysis, Design, Development, Implementation, and Evaluation model, the Good Research Practice program was made up of a total of 30 h of the blended learning both online and off-line. The results of this study showed that there were statistically significant differences in both knowledge and perception of research ethics in nursing students and nurses before and after the program had been implemented. The concepts of professional nursing ethics, moral issues, and bioethics were often confused with one another and not clearly defined. Therefore, the concept and scope of bioethics, moral judgment, and overall nursing ethics should be well defined and conceptualized in the future. This study suggested integrating research ethics education in the nursing curriculum as a required course of study for nursing students and as part of the in-service training program for nurses in order to improve research ethics in nursing research in Korea. © The Author(s) 2013.

40 CFR 792.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) GOOD LABORATORY PRACTICE STANDARDS General Provisions § 792.1 Scope. (a) This part prescribes good laboratory practices for conducting studies relating to health effects, environmental effects, and chemical...

40 CFR 792.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) GOOD LABORATORY PRACTICE STANDARDS General Provisions § 792.1 Scope. (a) This part prescribes good laboratory practices for conducting studies relating to health effects, environmental effects, and chemical...

Good Policy, Good Practice II. Improving Outcomes and Productivity in Higher Education: A Guide for Policymakers

ERIC Educational Resources Information Center

Brenneman, Meghan Wilson; Callan, Patrick M.; Ewell, Peter T.; Finney, Joni E.; Jones, Dennis P.; Zis, Stacey

2010-01-01

This new edition of "Good Policy, Good Practice II" revises and updates the authors' 2007 publication. Like the earlier edition, it responds to one of the questions that is raised most frequently in the authors' work with public policy and education leaders as they begin to address the national and state imperatives to increase the proportion of…

The ethical dimensions of wildlife disease management in an evolutionary context.

PubMed

Crozier, Gkd; Schulte-Hostedde, Albrecht I

2014-08-01

Best practices in wildlife disease management require robust evolutionary ecological research (EER). This means not only basing management decisions on evolutionarily sound reasoning, but also conducting management in a way that actively contributes to the on-going development of that research. Because good management requires good science, and good science is 'good' science (i.e., effective science is often science conducted ethically), good management therefore also requires practices that accord with sound ethical reasoning. To that end, we propose a two-part framework to assist decision makers to identify ethical pitfalls of wildlife disease management. The first part consists of six values - freedom, fairness, well-being, replacement, reduction, and refinement; these values, developed for the ethical evaluation of EER practices, are also well suited for evaluating the ethics of wildlife disease management. The second part consists of a decision tree to help identify the ethically salient dimensions of wildlife disease management and to guide managers toward ethically responsible practices in complex situations. While ethical reasoning cannot be used to deduce from first principles what practices should be undertaken in every given set of circumstances, it can establish parameters that bound what sorts of practices will be acceptable or unacceptable in certain types of scenarios.

76 FR 49509 - Records Schedules; Availability and Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-10

... Agency (N1-258-09-3, 1 item, 1 temporary item). Good Farming Practice Documentation, including producer... reconsideration of adverse good farming practice determinations. 3. Department of Agriculture, Risk Management... materials, legislation files, negotiation files, review files, unfair trade practices files, and...

76 FR 55067 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-06

... Pharmaceutical Current Good Manufacturing Practice AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Good Manufacturing Practice--(OMB Control Number 0910-0563)--Extension The guidance is intended to... products, on how to resolve disputes of scientific and technical issues relating to current good...

21 CFR 184.1449 - Manganese citrate.

Code of Federal Regulations, 2014 CFR

2014-04-01

... § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing... ingredient is based upon the following current good manufacturing practice conditions of use: (1) The... is used in the following foods at levels not to exceed current good manufacturing practice: baked...

I Am Mentor, I Am Coach

ERIC Educational Resources Information Center

Augustine-Shaw, Donna; Reilly, Marceta

2017-01-01

Preparing good leaders depends not only on providing good initial professional learning, but also on creating a strong support structure during the early years of practice. However, what good mentoring looks and sounds like varies widely in practice. Many mentoring programs for education leaders consist of buddy-like relationships that provide…

Nonlinear differential equations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dresner, L.

1988-01-01

This report is the text of a graduate course on nonlinear differential equations given by the author at the University of Wisconsin-Madison during the summer of 1987. The topics covered are: direction fields of first-order differential equations; the Lie (group) theory of ordinary differential equations; similarity solutions of second-order partial differential equations; maximum principles and differential inequalities; monotone operators and iteration; complementary variational principles; and stability of numerical methods. The report should be of interest to graduate students, faculty, and practicing scientists and engineers. No prior knowledge is required beyond a good working knowledge of the calculus. The emphasis ismore » on practical results. Most of the illustrative examples are taken from the fields of nonlinear diffusion, heat and mass transfer, applied superconductivity, and helium cryogenics.« less

Images of otoscopy: rate and extent of non-compliance with good practice standards.

PubMed

Crundwell, G; Harmer, J; Maltby, M; Mills, T; Neumann, C; Walsh, L; Baguley, D

2015-01-01

The British Society of Audiology has produced clear guidelines as to how otoscopy should be undertaken; however, no nationally recognised guidelines exist for the wider clinical community. Images of otoscopy appear in many books, journals, magazines and websites. This study aimed to determine the rate of non-compliance with good practice in images of otoscopy, the seriousness of the breach, and whether this is more common in sites for professionals or the general public. Google Images was searched using the terms 'otoscopy' and 'ear examination'. A total of 200 images were identified and collated. The images were reviewed for compliance with good practice standards. Only 12.75 per cent of the images were graded as having no breach of good practice standards. Professional websites have a responsibility to show best practice. When choosing an image, the source of the image needs to be carefully considered.

Status quo of management of the human tissue banks in Taiwan.

PubMed

Chou, Ching-Pang; Chou, Szu-Cheng; Chen, Ying-Hua; Chen, Yu-Hsuan; Lee, Ming-Shin

2017-03-01

As the technologies associated with transplantation and biological tissue engineering continue to advance, human cells and tissues form an integral part to the practice of regenerative medicine. The patient's use of tissues entails the risk of introducing, transmitting and spreading communicable diseases. To prevent such risk and to ensure that the human organs, tissues and cells remain intact and functional after being handled and processed, the transplanted tissues must be subject to good management standards through all stages of collection, screening, processing, storage and distribution as the safety of the users is of the utmost importance. On February 2009, the government of Taiwan promulgated the Regulations for Administration on Human Organ Bank that requires all human tissues banks to adhere to the Good Tissue Practice for Human Organ, Tissue and Cell in terms of establishment and operation in order to cope with the international management trend and the development and management need of the domestic industry. Six years have passed since the law became effective. This article seeks to introduce the current management mechanism and status quo of management of human tissue banks in Taiwan. We also conducted statistical analysis of the data relating to the tissue banks to identify potential risks and the room for improvement. The study concludes that human tissue banks in Taiwan are on the right track with their management practice, leading to a state of steady development and progress.

Intelligent reservoir operation system based on evolving artificial neural networks

NASA Astrophysics Data System (ADS)

Chaves, Paulo; Chang, Fi-John

2008-06-01

We propose a novel intelligent reservoir operation system based on an evolving artificial neural network (ANN). Evolving means the parameters of the ANN model are identified by the GA evolutionary optimization technique. Accordingly, the ANN model should represent the operational strategies of reservoir operation. The main advantages of the Evolving ANN Intelligent System (ENNIS) are as follows: (i) only a small number of parameters to be optimized even for long optimization horizons, (ii) easy to handle multiple decision variables, and (iii) the straightforward combination of the operation model with other prediction models. The developed intelligent system was applied to the operation of the Shihmen Reservoir in North Taiwan, to investigate its applicability and practicability. The proposed method is first built to a simple formulation for the operation of the Shihmen Reservoir, with single objective and single decision. Its results were compared to those obtained by dynamic programming. The constructed network proved to be a good operational strategy. The method was then built and applied to the reservoir with multiple (five) decision variables. The results demonstrated that the developed evolving neural networks improved the operation performance of the reservoir when compared to its current operational strategy. The system was capable of successfully simultaneously handling various decision variables and provided reasonable and suitable decisions.

Simulation Evaluation of Pilot Inputs for Real Time Modeling During Commercial Flight Operations

NASA Technical Reports Server (NTRS)

Martos, Borja; Ranaudo, Richard; Oltman, Ryan; Myhre, Nick

2017-01-01

Aircraft dynamics characteristics can only be identified from flight data when the aircraft dynamics are excited sufficiently. A preliminary study was conducted into what types and levels of manual piloted control excitation would be required for accurate Real-Time Parameter IDentification (RTPID) results by commercial airline pilots. This includes assessing the practicality for the pilot to provide this excitation when cued, and to further understand if pilot inputs during various phases of flight provide sufficient excitation naturally. An operationally representative task was evaluated by 5 commercial airline pilots using the NASA Ice Contamination Effects Flight Training Device (ICEFTD). Results showed that it is practical to use manual pilot inputs only as a means of achieving good RTPID in all phases of flight and in flight turbulence conditions. All pilots were effective in satisfying excitation requirements when cued. Much of the time, cueing was not even necessary, as just performing the required task provided enough excitation for accurate RTPID estimation. Pilot opinion surveys reported that the additional control inputs required when prompted by the excitation cueing were easy to make, quickly mastered, and required minimal training.

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

Good documentation practice in clinical research.

PubMed

Bargaje, Chitra

2011-04-01

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.

Managing Safety and Operations: The Effect of Joint Management System Practices on Safety and Operational Outcomes.

PubMed

Tompa, Emile; Robson, Lynda; Sarnocinska-Hart, Anna; Klassen, Robert; Shevchenko, Anton; Sharma, Sharvani; Hogg-Johnson, Sheilah; Amick, Benjamin C; Johnston, David A; Veltri, Anthony; Pagell, Mark

2016-03-01

The aim of this study was to determine whether management system practices directed at both occupational health and safety (OHS) and operations (joint management system [JMS] practices) result in better outcomes in both areas than in alternative practices. Separate regressions were estimated for OHS and operational outcomes using data from a survey along with administrative records on injuries and illnesses. Organizations with JMS practices had better operational and safety outcomes than organizations without these practices. They had similar OHS outcomes as those with operations-weak practices, and in some cases, better outcomes than organizations with safety-weak practices. They had similar operational outcomes as those with safety-weak practices, and better outcomes than those with operations-weak practices. Safety and operations appear complementary in organizations with JMS practices in that there is no penalty for either safety or operational outcomes.

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...

Evaluation Instruments and Good Practices in Online Education

ERIC Educational Resources Information Center

Baldwin, Sally J.; Trespalacios, Jesús

2017-01-01

Chickering and Gamson's (1987) "Seven Principles for Good Practice in Undergraduate Education" offers extensively researched and validated tenets for best practices in higher education. After a review of the literature, twenty-eight evaluation instruments currently used to design and review online courses in higher education institutions…

A clinical governance framework for blood services.

PubMed

Williamson, L M; Benjamin, R J; Devine, D V; Katz, L M; Pink, J

2015-05-01

The elements of clinical governance, which ensure excellence in clinical care, can be applied to blood services. In this survey, their application in a range of blood providers was gauged, with the aim of identifying best practice and producing a generalizable framework. The Medical Directors of members of the Alliance of Blood Operators surveyed how different elements of clinical governance operated within their organizations and developed recommendations applicable in the blood service environment. The recommendations that emerged highlighted the importance of an organization's culture, with the delivery of optimal clinical governance being a corporate responsibility. Senior management must agree and promote a set of values to ensure that the system operates with the patient and donor at its heart. All staff should understand how their role fits into the 'journey to the patient', and a culture of openness promoted. Thus, reporting of errors and risks should be actively sought and praised, with penalties applied for concealment. Systems should exist to collect, analyse and escalate clinical outcomes, safety data, clinical risk assessments, incident reports and complaints to inform organizational learning. Clinical governance principles from general health care can be applied within blood services to complement good manufacturing practice. This requires leadership, accountability, an open culture and a drive for continuous improvement and excellence in clinical care. © 2015 International Society of Blood Transfusion.

Knowledge, attitude, and practice regarding dengue virus infection among inhabitants of Aceh, Indonesia: a cross-sectional study.

PubMed

Harapan, Harapan; Rajamoorthy, Yogambigai; Anwar, Samsul; Bustamam, Aslam; Radiansyah, Arsil; Angraini, Pradiba; Fasli, Riny; Salwiyadi, Salwiyadi; Bastian, Reza Akbar; Oktiviyari, Ade; Akmal, Imaduddin; Iqbalamin, Muhammad; Adil, Jamalul; Henrizal, Fenni; Darmayanti, Darmayanti; Pratama, Rovy; Setiawan, Abdul Malik; Mudatsir, Mudatsir; Hadisoemarto, Panji Fortuna; Dhimal, Mandira Lamichhane; Kuch, Ulrich; Groneberg, David Alexander; Imrie, Allison; Dhimal, Meghnath; Müller, Ruth

2018-02-27

The Indonesian region of Aceh was the area most severely affected by the earthquake and tsunami of 26 December 2004. Department of Health data reveal an upward trend of dengue cases in Aceh since the events of the tsunami. Despite the increasing incidence of dengue in the region, there is limited understanding of dengue among the general population of Aceh. The aim of this study was to assess the knowledge, attitude, and practice (KAP) regarding dengue among the people of Aceh, Indonesia in order to design intervention strategies for an effective dengue prevention program. A community-based cross-sectional study was conducted in Aceh between November 2014 and March 2015 with a total of 609 participants living in seven regencies and two municipalities. Information on the socio-demographic characteristics of participants and their KAP regarding dengue was collected using a pre-tested structured questionnaire. The KAP status (good vs. poor) of participants with different socio-demographic characteristics was compared using Chi Square-test, ANOVA or Fisher's exact test as appropriate. Logistic regression analysis was used to determine the predictors of each KAP domain. We found that 45% of participants had good knowledge regarding dengue and only 32% had good attitudes and good dengue preventive practices. There was a significant positive correlation between knowledge and attitudes, knowledge and practice, and attitudes and practice. In addition, people who had good knowledge were 2.7 times more likely to have good attitudes, and people who had good attitudes were 2.2 times more likely to have good practices regarding dengue. The level of education, occupation, marital status, monthly income, socioeconomic status (SES) and living in the city were associated with the knowledge level. Occupation, SES, and having experienced dengue fever were associated with attitudes. Education, occupation, SES and type of residence were associated with preventive practices. Our study suggests that dengue prevention programs are required to increase KAP levels regarding dengue in the communities of Aceh.

An assessment of workplace programmes designed to control inhalation risks using respiratory protective equipment.

PubMed

Bell, Nikki; Vaughan, Nicholas P; Morris, Len; Griffin, Peter

2012-04-01

Few studies have assessed respiratory protective equipment (RPE) failures at the organizational level despite evidence to suggest that compliance with good practice may be low. The aim of this study was to develop an understanding of what current RPE programmes look like across industry and how this compares with good practice. Twenty cross-industry site visits were conducted with companies that had RPE programmes in place. Visits involved management interviews to explore current RPE systems and procedures and the decision making underpinning these. Observations of RPE operatives were included followed by short interviews to discuss the behaviours observed. Post-site assessments jointly undertaken by an RPE scientist and psychologist produced ratings for each site on six critical aspects of RPE programmes (knowledge/awareness, selection, use, training/information, supervision, and storage/cleaning/maintenance). Overall ratings for theoretical competence (i.e. management knowledge of RPE) and practical control (i.e. actual RPE practice on the shop floor) were also given. Qualitative analysis was performed on all interview data. The performance of RPE programmes varied across industry. Fewer than half the companies visited were considered to have an acceptable level of theoretical competence and practical control. Four distinct groups emerged from the 20 sites studied, ranging from Learners (low theoretical competence and practical control--four sites), Developers (acceptable theoretical competence and low practical control--five sites), and Fortuitous (low theoretical competence and acceptable practical control--two sites), to Proficient (acceptable theoretical competence and practical control--nine sites). None of the companies visited were achieving optimal control through the use of RPE. Widespread inadequacies were found with programme implementation, particularly training, supervision, and maintenance. Our taxonomy based on the four groups (Learners, Developers, Fortuitous, and Proficient) provided a useful expert-informed tool for explaining the variation in performance of RPE programmes across industry. Although further research and development are required, this taxonomy offers a useful starting point for the development of practical tools that may assist managers in making the much-needed improvements to all facets of programme implementation, particularly training, supervision, and maintenance.

A knowledge infrastructure for occupational safety and health.

PubMed

van Dijk, Frank J H; Verbeek, Jos H; Hoving, Jan L; Hulshof, Carel T J

2010-12-01

Occupational Safety and Health (OSH) professionals should use scientific evidence to support their decisions in policy and practice. Although examples from practice show that progress has been made in evidence-based decision making, there is a challenge to improve and extend the facilities that support knowledge translation in practice. A knowledge infrastructure that supports OSH practice should include scientific research, systematic reviews, practice guidelines, and other tools for professionals such as well accessible virtual libraries and databases providing knowledge, quality tools, and good learning materials. A good infrastructure connects facilities with each other and with practice. Training and education is needed for OSH professionals in the use of evidence to improve effectiveness and efficiency. New initiatives show that occupational health can profit from intensified international collaboration to establish a good functioning knowledge infrastructure.

W-Sb-Te phase-change material: A candidate for the trade-off between programming speed and data retention

NASA Astrophysics Data System (ADS)

Peng, Cheng; Wu, Liangcai; Rao, Feng; Song, Zhitang; Yang, Pingxiong; Song, Hongjia; Ren, Kun; Zhou, Xilin; Zhu, Min; Liu, Bo; Chu, Junhao

2012-09-01

W-Sb-Te phase-change material has been proposed to improve the performance of phase-change memory (PCM). Crystallization temperature, crystalline resistance, and 10-year data retention of Sb2Te increase markedly by W doping. The Wx(Sb2Te)1-x films crystallize quickly into a stable hexagonal phase with W uniformly distributing in the crystal lattice, which ensures faster SET speed and better operation stability for the application in practical device. PCM device based on W0.07(Sb2Te)0.93 shows ultrafast SET operation (6 ns) and good endurance (1.8 × 105 cycles). W-Sb-Te material is a promising candidate for the trade-off between programming speed and data retention.

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 additional data collection is justified by the benefits of improved resource allocation decisions afforded by the additional evidence generated and the accompanying reduction in uncertainty. The ex post evaluation of a PBRSA should, however, be a multidimensional exercise that assesses many aspects, including not only the impact on long-term cost-effectiveness and whether appropriate evidence was generated but also process indicators, such as whether and how the evidence was used in coverage or reimbursement decisions, whether budget and time were appropriate, and whether the governance arrangements worked well. There is an important gap in the literature of structured ex post evaluation of PBRSAs. As an innovation in and of themselves, PBRSAs should also be evaluated from a long-run societal perspective in terms of their impact on dynamic efficiency (eliciting the optimal amount of innovation). Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

29 CFR 790.18 - “Administrative practice or enforcement policy.”

Code of Federal Regulations, 2011 CFR

2011-07-01

... Faith Reliance on Administrative Regulations, Etc. § 790.18 “Administrative practice or enforcement... employee, because of reliance in good faith on an administrative practice or enforcement policy only (1... acts or omissions led the employer to believe in good faith that such acts or omissions were not...

29 CFR 790.18 - “Administrative practice or enforcement policy.”

Code of Federal Regulations, 2013 CFR

2013-07-01

... Faith Reliance on Administrative Regulations, Etc. § 790.18 “Administrative practice or enforcement... employee, because of reliance in good faith on an administrative practice or enforcement policy only (1... acts or omissions led the employer to believe in good faith that such acts or omissions were not...

29 CFR 790.18 - “Administrative practice or enforcement policy.”

Code of Federal Regulations, 2012 CFR

2012-07-01

... Faith Reliance on Administrative Regulations, Etc. § 790.18 “Administrative practice or enforcement... employee, because of reliance in good faith on an administrative practice or enforcement policy only (1... acts or omissions led the employer to believe in good faith that such acts or omissions were not...

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 procedures...

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 procedures...

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 procedures...

16 CFR 453.3 - Misrepresentations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Misrepresentations. (a) Embalming provisions—(1) Deceptive acts or practices. In selling or offering to sell funeral... practices. In selling or offering to sell funeral goods or funeral services to the public, it is a deceptive... practices. In selling or offering to sell funeral goods and funeral services to the public, it is a...

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

Code of Federal Regulations, 2011 CFR

2011-01-01

... 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 procedures...) Allow no visitors except under controlled conditions to minimize the introduction of Salmonella and...

The constraints of good governance practice in national solid waste management policy (NSWMP) implementation: A case study of Malaysia

NASA Astrophysics Data System (ADS)

Wee, Seow Ta; Abas, Muhamad Azahar; Chen, Goh Kai; Mohamed, Sulzakimin

2017-10-01

Nowadays, international donors have emphasised on the adoption of good governance practices in solid waste management which include policy implementation. In Malaysia, the National Solid Waste Management Policy (NSWMP) was introduced as the main guideline for its solid waste management and the Malaysian government has adopted good governance practice in the NSMWP implementation. However, the good governance practices implemented by the Malaysian government encountered several challenges. This study was conducted to explore the good governance constraints experienced by stakeholders in the NSWMP implementation. An exploratory research approach is applied in this study through in-depth interviews with several government agencies and concessionaires that involved in the NSWMP implementation in Malaysia. A total of six respondents took part in this study. The findings revealed three main good governance constraints in the NSWMP implementation, namely inadequate fund, poor staff's competency, and ambiguity of policy implementation system. Moreover, this study also disclosed that the main constraint influenced the other constraints. Hence, it is crucial to identify the main constraint in order to minimise its impact on the other constraints.

Social support in the practices of informal providers: The case of patent and proprietary medicine vendors in Nigeria.

PubMed

Sieverding, Maia; Liu, Jenny; Beyeler, Naomi

2015-10-01

The social and institutional environments in which informal healthcare providers operate shape their health and business practices, particularly in contexts where regulatory enforcement is weak. In this study, we adopt a social capital perspective to understanding the social networks on which proprietary and patent medicine vendors (PPMVs) in Nigeria rely for support in the operation of their shops. Data are drawn from 70 in-depth interviews with PPMVs in three states, including interviews with local leaders of the PPMV professional association. We find that PPMVs primarily relied on more senior colleagues and formal healthcare professionals for informational support, including information about new medicines and advice on how to treat specific cases of illness. For instrumental support, including finance, start-up assistance, and intervention with regulatory agencies, PPMVs relied on extended family, the PPMVs with whom they apprenticed, and the leaders of their professional association. PPMVs' networks also provided continual reinforcement of what constitutes good PPMV practice through admonishments to follow scope of practice limitations. These informal reminders, as well as monitoring activities conducted by the professional association, served to reinforce PPMVs' concern with avoiding negative customer health outcomes, which were perceived to be detrimental to their business reputations. That PPMVs' networks both encouraged practices to reduce the likelihood of poor health outcomes, and provided advice regarding customers' health conditions, highlights the potential impact of informal providers' access to different forms of social capital on their delivery of health services, as well as their success as microenterprises. Copyright © 2015 Elsevier Ltd. All rights reserved.

Good cell culture practices &in vitro toxicology.

PubMed

Eskes, Chantra; Boström, Ann-Charlotte; Bowe, Gerhard; Coecke, Sandra; Hartung, Thomas; Hendriks, Giel; Pamies, David; Piton, Alain; Rovida, Costanza

2017-12-01

Good Cell Culture Practices (GCCP) is of high relevance to in vitro toxicology. The European Society of Toxicology In Vitro (ESTIV), the Center for Alternatives for Animal Testing (CAAT) and the In Vitro Toxicology Industrial Platform (IVTIP) joined forces to address by means of an ESTIV 2016 pre-congress session the different aspects and applications of GCCP. The covered aspects comprised the current status of the OECD guidance document on Good In Vitro Method Practices, the importance of quality assurance for new technological advances in in vitro toxicology including stem cells, and the optimized implementation of Good Manufacturing Practices and Good Laboratory Practices for regulatory testing purposes. General discussions raised the duality related to the difficulties in implementing GCCP in an academic innovative research framework on one hand, and on the other hand, the need for such GCCP principles in order to ensure reproducibility and robustness of in vitro test methods for toxicity testing. Indeed, if good cell culture principles are critical to take into consideration for all uses of in vitro test methods for toxicity testing, the level of application of such principles may depend on the stage of development of the test method as well as on the applications of the test methods, i.e., academic innovative research vs. regulatory standardized test method. Copyright © 2017 Elsevier Ltd. All rights reserved.

[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 activities depended on "cost", "human resources", "time to perform", and "advisory organization". These results suggest that employer awareness of the relationship between good management and occupational health is essential to the implementation of occupational health and safety practices in small-scale enterprises.

"Inclusive Working Life" in Norway--experience from "Models of Good Practice" enterprises.

PubMed

Lie, Arve

2008-08-01

To determine whether enterprises belonging to the Bank of Models of Good Practice were more successful than average Norwegian enterprises in the reduction of sickness absence, promotion of early return to work, and prevention of early retirement. In 2004 we selected 86 enterprises with a total of approximately 90000 employees from the Inclusive Working Life (IWL) Bank of Models of Good Practice. One representative of workers and one of management from each enterprise received a questionnaire on the aims, organization, and the results of the IWL program by mail. Data on sickness absence, use of early retirement, and disability retirement in the 2000-2004 period were collected from the National Insurance Registry. Data on comparable enterprises were obtained from the National Bureau of Statistics. The response rate was 65%. Although the IWL campaign was directed at reducing sickness absence, preventing early retirement, and promoting employment of the functionally impaired, most attention was paid to reducing sickness absence. Sickness absence rate in Models of Good Practice enterprises (8.2%) was higher than in comparable enterprises that were not part of the Models of Good Practice (6.9%). Implementation of many IWL activities, empowerment and involvement of employees, and good cooperation with the occupational health service were associated with a lower rate of sickness absence. On average, 0.7% new employees per year received disability pension, which is a significantly lower percentage than expected on the basis of the rate of 1.3% per year in comparable enterprises. Frequent use of disability pensioning was associated with high rate of sickness absence and having many employees older than 50 years. On average, 0.4% employees per year received early retirement compensation, which was expected on the basis of national estimates. Frequent use of early retirement was associated with having many employees older than 50 years. Models of Good Practice enterprises had a higher than expected sickness absence rate. This indicates that it is difficult to identify Models of Good Practice enterprises and that they cannot be treated as role model enterprises. Good cooperation with the occupational health service and the empowerment and involvement of the employees is associated with a low sickness absence rate.

Intraoperative radiotherapy in combined treatment of sinonasal malignant tumors

NASA Astrophysics Data System (ADS)

Novikov, V. A.; Gribova, O. V.; Vasiljev, R. V.; Choynzonov, E. L.; Shtin, V. I.; Shiianova, A. A.; Surkova, P. V.; Starceva, Zh. A.; Shilova, O. G.

2017-09-01

Obvious advantage of IORT (intraoperative radiotherapy) is that the radiation source is delivered directly to the bed of the tumor during surgery, thus avoiding the negative impact on the skin, subcutaneous tissue and reducing the risk of fibrosis. Sinonasal tumors—a convenient object for intraoperative radiotherapy application (surface location, relatively small size tumors, good operational access). The surface location and comparatively small size of neoplasms, good operational access provide an efficient and accurate transfer of the electron beam to the postoperative cavity to increase the irradiation dose in the areas of the most probable recurrence, which makes the tumors of this localization a convenient object for the use of the intraoperative radiation therapy. The treatment was conducted using a mobile compact betatron (MIB-6E), 10-12 Gy single dose. IORT session extends surgery period by 30 min. There were no pathological clinical and laboratory reactions on IORT in the early postoperative period. Carrying out the procedure is possible in various standard operating rooms. It does not require special security measures for the patients and the staff. IORT with the help of electron beam allows avoiding post-radiation reactions and achieving a 5-year—disease-free survival of 66% of the patients. IORT session is possible through a minimal incision during organ preservation surgeries. Evident economic feasibility provides the prospects of applying IORT in the clinical practice.

Pay for performance of Estonian family doctors and impact of different practice- and patient-related characteristics on a good outcome: A quantitative assessment.

PubMed

Merilind, Eero; Salupere, Rauno; Västra, Katrin; Kalda, Ruth

2016-01-01

Several practice- and patient-related characteristics are reported to have an influence on a good quality outcome. Estonia started the pay-for-performance (P4P) system for family doctors (FDs) in 2006. Every year the number of FDs participating in P4P has increased, but only half of the FDs achieved good outcome. The aim of this study was to find out which practice- and patient-related characteristics could have an impact on a good outcome. The study was conducted using the database from the Estonian Health Insurance Fund. All working FDs were divided into two groups (with "good" and "poor" outcomes) according their achievements in P4P. We chose characteristics which described structure (practice list size, number of doctors, composition of FDs list: age, number of chronically ill patients) during the observation period 2006-2012. During the observation period 2006-2012, the number of FDs with a good outcome in P4P increased from 6% (2006) to 53% (2012). The high number of FDs in primary care teams, longer experience of participation in P4P and the smaller number of patients on FDs' lists all have an impact on a good outcome. The number of chronically ill patients in FDs lists has no significant effect on an outcome, but P4P increases the number of disease-diagnosed patients. Different practice and patient-related characteristics have an impact on a good outcome. As workload increases, smaller lists of FDs patients or increased staff levels are needed in order to maintain a good outcome. Copyright © 2016 The Lithuanian University of Health Sciences. Production and hosting by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

[Perthes disease--results of a containment-oriented therapy concept].

PubMed

Rühmann, O; Lazović, D; Wirth, C J; Gossé, F; Franke, J

1997-01-01

In a retrospective study a treatment concept for Perthes' disease dependent on the containment was applied. 49 hips of 41 children (9 female, 32 male) were treated between 01. 01. 1990 and 31. 12. 1995. In our concept of treatment a varus femoral osteotomy was performed in 28 cases with not contained hips or less than 4/5 coverage of the femoral head (X-ray/MRI). The other 21 well contained hips with 4/5 coverage or more were treated conservatively with physiotherapy and in case of joint effusion and pain additionally with the use of crutches (partial weight bearing) and anti-inflammatory medication. The average age in the non-operative group at the time of first investigation was 4 years and 9 months (3 y./1 m. to 7 y./1 m.) and 6 years and 3 months (4 y/2 m. to 10 y/0 m.) at our last examination (mean follow up 17.7 months, range of 6 to 72 months). At the time of indication for a varus femoral osteotomy the patients had an average age 6 years and 1 month (3 y./6 m. to 10 y./2 m.), the mean age at the last postoperative examination was 7 years and 11 months (4 y./8 m. to 12 y./5 m.) with an average follow up of 21.5 months (6 to 77 months). For the conservatively treated children we achieved good results (still well contained hips with 4/5 coverage, no decrease of function, no increase of pain) in 85.7% (18 of 21 cases). In 85.7% (24 of 28 cases) we found good results (well contained hips, increase of coverage, no decrease of function, no increase of pain) in the operation group. The presented concept of therapy in Perthes' disease was practicable for all patients and included the possibility of decision for operative or non-operative treatment. In both groups we achieved good results in 85.7% of the cases.

Workplace etiquette for the medical practice employee.

PubMed

Hills, Laura

2010-01-01

Medical practice workplace etiquette is slowly being modified and fine-tuned. New workplace etiquette rules have become necessary because of advances in communications technology, shifting norms, and expectations of what constitutes good manners. Today's medical practice employees must concern themselves with traditional workplace manners but also the manners that come into play when they make or receive cell phone calls, text messages, and e-mails, and when they use social networking media outside of work. This article offers 25 rules for good manners in the medical practice that relate to the ways employees interact with people today, whether face-to-face or when using electronic communications technologies. It offers practical guidelines for making introductions both inside and outside the medical practice. This article also provides a self-quiz to help medical practice employees assess their workplace etiquette intelligence and 12 tips for good workplace table manners.

The "general recognition and acceptance" standard of objectivity for good faith in prescribing: legal and medical implications.

PubMed

Brushwood, David B

2007-01-01

The United States Court of Appeals for the 4th Circuit has ruled that a jury considering charges of drug trafficking against a pain management physician should be instructed that the defendant's good faith is a defense to the charges. The court rejected a subjective standard of good faith, and instead ruled that the good faith of the defendant must be evaluated from an objective perspective. This objective standard requires that the jury determine whether the defendant was practicing in accordance with the standard generally recognized and accepted in the United States. General recognition and acceptance are determined on a case-by-case basis, within the context of a defendant's practice. Simply because a physician's practice is out of the norm for many physicians does not mean it can't be generally recognized and accepted within the standard of medical practice. Expert witness testimony of pain management physicians will assist juries in the application of this standard for good faith in prescribing.

Prone position craniotomy in pregnancy without fetal heart rate monitoring.

PubMed

Jacob, Jean; Alexander, Ashish; Philip, Shoba; Thomas, Anoop

2016-09-01

A pregnant patient in second trimester scheduled for posterior fossa craniotomy in prone position is a challenge for the anesthesiologist. Things to consider are physiological changes during pregnancy, non-obstetric surgery in pregnant patients, neuroanesthetic principles, effects of prone positioning, and need for fetal heart rate (FHR) monitoring. We have described the anesthetic management of this case and discussed intra-operative FHR monitoring including controversies about its role, indications, and various options available as per fetal gestational age. In our case we attempted intermittent intra-operative FHR monitoring to optimize maternal positioning and fetal oxygenation even though the fetus was pre-viable. However the attempt was abandoned due to practical difficulties with prone positioning. Patient made good neurological recovery following the procedure and delivered a healthy term baby 4 months later. Decisions regarding fetal monitoring should be individualized based on viability of the fetus and feasibility of emergency cesarean delivery. Good communication between a multidisciplinary team involving neurosurgeon, anesthesiologist, obstetrician, and neonatologist is important for a successful outcome for mother and fetus. We conclude that prone position neurosurgery can safely be carried out in a pregnant patient with pre-viable fetus without FHR monitoring. Copyright © 2016 Elsevier Inc. All rights reserved.

Solid phase microbial fuel cell (SMFC) for harnessing bioelectricity from composite food waste fermentation: influence of electrode assembly and buffering capacity.

PubMed

Mohan, S Venkata; Chandrasekhar, K

2011-07-01

Solid phase microbial fuel cells (SMFC; graphite electrodes; open-air cathode) were designed to evaluate the potential of bioelectricity production by stabilizing composite canteen based food waste. The performance was evaluated with three variable electrode-membrane assemblies. Experimental data depicted feasibility of bioelectricity generation from solid state fermentation of food waste. Distance between the electrodes and presence of proton exchange membrane (PEM) showed significant influence on the power yields. SMFC-B (anode placed 5 cm from cathode-PEM) depicted good power output (463 mV; 170.81 mW/m(2)) followed by SMFC-C (anode placed 5 cm from cathode; without PEM; 398 mV; 53.41 mW/m(2)). SMFC-A (PEM sandwiched between electrodes) recorded lowest performance (258 mV; 41.8 mW/m(2)). Sodium carbonate amendment documented marked improvement in power yields due to improvement in the system buffering capacity. SMFCs operation also documented good substrate degradation (COD, 76%) along with bio-ethanol production. The operation of SMFC mimicked solid-sate fermentation which might lead to sustainable solid waste management practices. Copyright © 2011 Elsevier Ltd. All rights reserved.

[Assessment of hygiene practices in anaesthesia between 1998 and 2007 in Lorraine].

PubMed

Anselme, S; Boileau, S; Vedel, M; Muller, C; Blech, M-F; Bouaziz, H

2009-01-01

To study the assessment of hygiene practices in anaesthesia in Lorraine between 1998 and 2007, after recommendations from the French Society of Anaesthesia and Reanimation (SFAR) in December 1997, and different local actions. Two surveys performed at a nine-year interval in Lorraine hospitals. Questionnaires about risk infection management and hygiene practices were sent by post to all anaesthetists, nurse anaesthetists and recovery room nurses in 1998 (n=279) and in 2007 (n=259). Between the two surveys multidrug-resistant bacteria signalling, movements of the staff in operating rooms, septic isolation protocol and management of single-use disposable anaesthesia material have been improved (p<0.05). Central venous catheters are less performed in recovery rooms and rings wearing decreased by 16% (p<0.05). Wearing of nonsterile gloves for peripheral venous catheter and intubation is not generalized (p<0.05). About half of the hospitals have cleanup procedures of anaesthesia furniture. Washing of hands by anaesthesia staff is not sometimes respected but it's more frequent for medicine preparation and between two operations. A good skin disinfection (cleaning - rinsing - drying - antiseptic) is more recurrent in 2007 (61.4%) than in 1998 (41.9%) for arterial catheter. Wearing of glasses for intubation is each times rare, about 15%. Hygiene practices in anaesthesia in Lorraine have been improved between the two surveys by recommendations from the Sfar and the work of the Antenne Régional de Lorraine (audits, manuals, formations). Promising progress has been made but some points must still be worked on.

76 FR 2123 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-12

...; Current Good Manufacturing Practice Quality System Regulation AGENCY: Food and Drug Administration, HHS... information entitled ``Current Good Manufacturing Practice Quality System Regulation'' has been approved by...

21 CFR 184.1143 - Ammonium sulfate.

Code of Federal Regulations, 2010 CFR

2010-04-01

... chapter, and processing aid as defined in § 170.3(o)(24) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.15 percent for baked goods as defined in...

Adaptive model training system and method

DOEpatents

Bickford, Randall L; Palnitkar, Rahul M; Lee, Vo

2014-04-15

An adaptive model training system and method for filtering asset operating data values acquired from a monitored asset for selectively choosing asset operating data values that meet at least one predefined criterion of good data quality while rejecting asset operating data values that fail to meet at least the one predefined criterion of good data quality; and recalibrating a previously trained or calibrated model having a learned scope of normal operation of the asset by utilizing the asset operating data values that meet at least the one predefined criterion of good data quality for adjusting the learned scope of normal operation of the asset for defining a recalibrated model having the adjusted learned scope of normal operation of the asset.

Adaptive model training system and method

DOEpatents

Bickford, Randall L; Palnitkar, Rahul M

2014-11-18

An adaptive model training system and method for filtering asset operating data values acquired from a monitored asset for selectively choosing asset operating data values that meet at least one predefined criterion of good data quality while rejecting asset operating data values that fail to meet at least the one predefined criterion of good data quality; and recalibrating a previously trained or calibrated model having a learned scope of normal operation of the asset by utilizing the asset operating data values that meet at least the one predefined criterion of good data quality for adjusting the learned scope of normal operation of the asset for defining a recalibrated model having the adjusted learned scope of normal operation of the asset.

Virtue Ethics, Care Ethics, and "The Good Life of Teaching"

ERIC Educational Resources Information Center

Silverman, Marissa

2012-01-01

In "The Good Life of Teaching: An Ethics of Professional Practice," Chris Higgins (2011) reminds people that "self-interest and altruism, personal freedom and social roles, and practical wisdom and personhood" have been ancient philosophical topics that remain vitally important in the practice of contemporary teaching and learning. One of the most…

Assuring Best Practice in Technology-Enhanced Learning Environments

ERIC Educational Resources Information Center

Keppell, Mike; Suddaby, Gordon; Hard, Natasha

2015-01-01

This paper documents the development and findings of the Good Practice Report on Technology-Enhanced Learning and Teaching funded by the Australian Learning and Teaching Council (ALTC). Developing the Good Practice Report required a meta-analysis of 33 ALTC learning and teaching projects relating to technology funded between 2006 and 2010. This…

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,…

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…

Protecting the public or setting the bar too high? Understanding the causes and consequences of regulatory actions of front-line regulators and specialized drug shop operators in Kenya.

PubMed

Wafula, Francis; Molyneux, Catherine; Mackintosh, Maureen; Goodman, Catherine

2013-11-01

The problem of poor regulatory compliance has been widely reported across private health providers in developing countries. Less known are the underlying reasons for poor compliance, especially with regards to the roles played by front-line regulatory staff, and the regulatory institution as a whole. We designed a qualitative study to address this gap, with the study questions and tools drawing on a conceptual framework informed by theoretical literature on regulation. Data were collected from specialized drug shops (SDSs) in two rural districts in Western Kenya in 2011 through eight focus group discussions, and from regulatory staff from organizations governing the pharmaceutical sector through a total of 24 in-depth interviews. We found that relationships between front-line regulators and SDS operators were a strong influence on regulatory behaviour, often resulting in non-compliance and perverse outcomes such as corruption. It emerged that separate regulatory streams operated in urban and rural locations, based mainly on differing relationships between the front-line regulators and SDS operators, and on broader factors such as the competition environment and community expectations. Effective incentive structures for regulatory staff were either absent, or poorly linked to performance in regulatory organizations, resulting in divergences between the purposes of the regulatory organization and activities of front-line staff. Given the rural-urban differences in the practice environment, the introduction of lower retail practice requirements for rural SDSs could be considered. This would allow illegally operated shops to be brought within the regulatory framework, facilitating good quality provision of essential commodities to marginalized areas, without lowering the practice requirements for the better complying urban SDSs. In addition, regulatory organizations need to devise incentives that better link the level of effort to rewards such as professional advancement of regulatory staff. Copyright © 2013 Elsevier Ltd. All rights reserved.

Protecting the public or setting the bar too high? Understanding the causes and consequences of regulatory actions of front-line regulators and specialized drug shop operators in Kenya

PubMed Central

Wafula, Francis; Molyneux, Catherine; Mackintosh, Maureen; Goodman, Catherine

2013-01-01

The problem of poor regulatory compliance has been widely reported across private health providers in developing countries. Less known are the underlying reasons for poor compliance, especially with regards to the roles played by front-line regulatory staff, and the regulatory institution as a whole. We designed a qualitative study to address this gap, with the study questions and tools drawing on a conceptual framework informed by theoretical literature on regulation. Data were collected from specialized drug shops (SDSs) in two rural districts in Western Kenya in 2011 through eight focus group discussions, and from regulatory staff from organizations governing the pharmaceutical sector through a total of 24 in-depth interviews. We found that relationships between front-line regulators and SDS operators were a strong influence on regulatory behaviour, often resulting in non-compliance and perverse outcomes such as corruption. It emerged that separate regulatory streams operated in urban and rural locations, based mainly on differing relationships between the front-line regulators and SDS operators, and on broader factors such as the competition environment and community expectations. Effective incentive structures for regulatory staff were either absent, or poorly linked to performance in regulatory organizations, resulting in divergences between the purposes of the regulatory organization and activities of front-line staff. Given the rural-urban differences in the practice environment, the introduction of lower retail practice requirements for rural SDSs could be considered. This would allow illegally operated shops to be brought within the regulatory framework, facilitating good quality provision of essential commodities to marginalized areas, without lowering the practice requirements for the better complying urban SDSs. In addition, regulatory organizations need to devise incentives that better link the level of effort to rewards such as professional advancement of regulatory staff. PMID:24016728

Automated Cell Enrichment of Cytomegalovirus-specific T cells for Clinical Applications using the Cytokine-capture System.

PubMed

Kumaresan, Pappanaicken; Figliola, Mathew; Moyes, Judy S; Huls, M Helen; Tewari, Priti; Shpall, Elizabeth J; Champlin, Richard; Cooper, Laurence J N

2015-10-05

The adoptive transfer of pathogen-specific T cells can be used to prevent and treat opportunistic infections such as cytomegalovirus (CMV) infection occurring after allogeneic hematopoietic stem-cell transplantation. Viral-specific T cells from allogeneic donors, including third party donors, can be propagated ex vivo in compliance with current good manufacturing practice (cGMP), employing repeated rounds of antigen-driven stimulation to selectively propagate desired T cells. The identification and isolation of antigen-specific T cells can also be undertaken based upon the cytokine capture system of T cells that have been activated to secrete gamma-interferon (IFN-γ). However, widespread human application of the cytokine capture system (CCS) to help restore immunity has been limited as the production process is time-consuming and requires a skilled operator. The development of a second-generation cell enrichment device such as CliniMACS Prodigy now enables investigators to generate viral-specific T cells using an automated, less labor-intensive system. This device separates magnetically labeled cells from unlabeled cells using magnetic activated cell sorting technology to generate clinical-grade products, is engineered as a closed system and can be accessed and operated on the benchtop. We demonstrate the operation of this new automated cell enrichment device to manufacture CMV pp65-specific T cells obtained from a steady-state apheresis product obtained from a CMV seropositive donor. These isolated T cells can then be directly infused into a patient under institutional and federal regulatory supervision. All the bio-processing steps including removal of red blood cells, stimulation of T cells, separation of antigen-specific T cells, purification, and washing are fully automated. Devices such as this raise the possibility that T cells for human application can be manufactured outside of dedicated good manufacturing practice (GMP) facilities and instead be produced in blood banking facilities where staff can supervise automated protocols to produce multiple products.

'A good shepherd, but with obstructive sleep apnoea syndrome': traditional uvulectomy case series and literature review.

PubMed

Ravesloot, M J L; de Vries, N

2011-09-01

In the West, removal of the uvula is predominantly undertaken as part of palatal surgery, in cases of obstructive sleep apnoea. In the developing world, such as the Middle East and Africa, uvulectomy is a more common practice. The uvula is removed for curative or preventive purposes, or as part of ritual practice. Due to immigration from developing to developed world countries, and to Western doctors working abroad, such doctors are increasingly being confronted with unfamiliar traditional healing practices, within a medical context. The Medline and Embase online databases were systematically searched for literature on traditional uvulectomy. We present a review of this literature. We also present the first report, to our best knowledge, of obstructive sleep apnoea as a late complication of traditional uvulectomy. Traditional uvulectomy may be complicated by post-operative haemorrhage and local infections, among many other problems. We report cases of obstructive sleep apnoea and snoring caused by palatal stenosis resulting from traditional uvulectomy during childhood.

Biocontainment, biosecurity, and security practices in beef feedyards.

PubMed

Brandt, Aric W; Sanderson, Michael W; DeGroot, Brad D; Thomson, Dan U; Hollis, Larry C

2008-01-15

To determine the biocontainment, biosecurity, and security practices at beef feedyards in the Central Plains of the United States. Survey. Managers of feedyards in Colorado, Kansas, Nebraska, Oklahoma, and Texas that feed beef cattle for finish before slaughter; feedyards had to have an active concentrated animal feeding operation permit with a 1-time capacity of >or= 1,000 cattle. A voluntary survey of feedyard personnel was conducted. Identified feedyard personnel were interviewed and responses regarding facility design, security, employees, disease preparedness, feedstuffs, hospital or treatment systems, sanitation, cattle sources, handling of sick cattle, and disposal of carcasses were collected in a database questionnaire. The survey was conducted for 106 feedyards with a 1-time capacity that ranged from 1,300 to 125,000 cattle. Feedyards in general did not have high implementation of biocontainment, biosecurity, or security practices. Smaller feedyards were, in general, less likely to use good practices than were larger feedyards. Results of the survey provided standard practices for biocontainment, biosecurity, and security in feedyards located in Central Plains states. Information gained from the survey results can be used by consulting veterinarians and feedyard managers as a basis for discussion and to target training efforts.

ASSESSMENT OF GOOD PRACTICES IN HOSPITAL FOOD SERVICE BY COMPARING EVALUATION TOOLS.

PubMed

Macedo Gonçalves, Juliana; Lameiro Rodrigues, Kelly; Santiago Almeida, Ângela Teresinha; Pereira, Giselda Maria; Duarte Buchweitz, Márcia Rúbia

2015-10-01

since food service in hospitals complements medical treatment, it should be produced in proper hygienic and sanitary conditions. It is a well-known fact that food-transmitted illnesses affect with greater severity hospitalized and immunosuppressed patients. good practices in hospital food service are evaluated by comparing assessment instruments. good practices were evaluated by a verification list following Resolution of Collegiate Directory n. 216 of the Brazilian Agency for Sanitary Vigilance. Interpretation of listed items followed parameters of RCD 216 and the Brazilian Association of Collective Meals Enterprises (BACME). Fisher's exact test was applied to detect whether there were statistically significant differences. Analysis of data grouping was undertaken with Unweighted Pair-group using Arithmetic Averages, coupled to a correlation study between dissimilarity matrixes to verify disagreement between the two methods. Good Practice was classified with mean total rates above 75% by the two methods. There were statistically significant differences between services and food evaluated by BACME instrument. Hospital Food Services have proved to show conditions of acceptable good practices. the comparison of interpretation tools based on RCD n. 216 and BACME provided similar results for the two classifications. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Improving the transition from medical school to internship - evaluation of a preparation for internship course.

PubMed

Scicluna, Helen A; Grimm, Michael C; Jones, Philip D; Pilotto, Louis S; McNeil, H Patrick

2014-02-03

This study evaluates the impact of a new 'Preparation for Internship' (PRINT) course, which was developed to facilitate the transition of University of New South Wales (UNSW) medical graduates from Medical School to Internship. During a period of major curricular reform, the 2007 (old program) and 2009 (new program) cohorts of UNSW final year students completed the Clinical Capability Questionnaire (CCQ) prior to and after undertaking the PRINT course. Clinical supervisors' ratings and self-ratings of UNSW 2009 medical graduates were obtained from the Hospital-based Prevocational Progress Review Form. Prior to PRINT, students from both cohorts perceived they had good clinical skills, with lower ratings for capability in procedural skills, operational management, and administrative tasks. After completing PRINT, students from both cohorts perceived significant improvement in their capability in procedural skills, operational management, and administrative tasks. Although PRINT also improved student-perceived capability in confidence, interpersonal skills and collaboration in both cohorts, curriculum reform to a new outcomes-based program was far more influential in improving self-perceptions in these facets of preparedness for hospital practice than PRINT. The PRINT course was most effective in improving students' perceptions of their capability in procedural skills, operational management and administrative tasks, indicating that student-to-intern transition courses should be clinically orientated, address relevant skills, use experiential learning, and focus on practical tasks. Other aspects that are important in preparation of medical students for hospital practice cannot be addressed in a PRINT course, but major improvements are achievable by program-wide curriculum reform.

Extended dynamic mode decomposition with dictionary learning: A data-driven adaptive spectral decomposition of the Koopman operator

NASA Astrophysics Data System (ADS)

Li, Qianxiao; Dietrich, Felix; Bollt, Erik M.; Kevrekidis, Ioannis G.

2017-10-01

Numerical approximation methods for the Koopman operator have advanced considerably in the last few years. In particular, data-driven approaches such as dynamic mode decomposition (DMD)51 and its generalization, the extended-DMD (EDMD), are becoming increasingly popular in practical applications. The EDMD improves upon the classical DMD by the inclusion of a flexible choice of dictionary of observables which spans a finite dimensional subspace on which the Koopman operator can be approximated. This enhances the accuracy of the solution reconstruction and broadens the applicability of the Koopman formalism. Although the convergence of the EDMD has been established, applying the method in practice requires a careful choice of the observables to improve convergence with just a finite number of terms. This is especially difficult for high dimensional and highly nonlinear systems. In this paper, we employ ideas from machine learning to improve upon the EDMD method. We develop an iterative approximation algorithm which couples the EDMD with a trainable dictionary represented by an artificial neural network. Using the Duffing oscillator and the Kuramoto Sivashinsky partical differential equation as examples, we show that our algorithm can effectively and efficiently adapt the trainable dictionary to the problem at hand to achieve good reconstruction accuracy without the need to choose a fixed dictionary a priori. Furthermore, to obtain a given accuracy, we require fewer dictionary terms than EDMD with fixed dictionaries. This alleviates an important shortcoming of the EDMD algorithm and enhances the applicability of the Koopman framework to practical problems.

Improving the transition from medical school to internship – evaluation of a preparation for internship course

PubMed Central

2014-01-01

Background This study evaluates the impact of a new 'Preparation for Internship’ (PRINT) course, which was developed to facilitate the transition of University of New South Wales (UNSW) medical graduates from Medical School to Internship. Methods During a period of major curricular reform, the 2007 (old program) and 2009 (new program) cohorts of UNSW final year students completed the Clinical Capability Questionnaire (CCQ) prior to and after undertaking the PRINT course. Clinical supervisors’ ratings and self-ratings of UNSW 2009 medical graduates were obtained from the Hospital-based Prevocational Progress Review Form. Results Prior to PRINT, students from both cohorts perceived they had good clinical skills, with lower ratings for capability in procedural skills, operational management, and administrative tasks. After completing PRINT, students from both cohorts perceived significant improvement in their capability in procedural skills, operational management, and administrative tasks. Although PRINT also improved student-perceived capability in confidence, interpersonal skills and collaboration in both cohorts, curriculum reform to a new outcomes-based program was far more influential in improving self-perceptions in these facets of preparedness for hospital practice than PRINT. Conclusions The PRINT course was most effective in improving students’ perceptions of their capability in procedural skills, operational management and administrative tasks, indicating that student-to-intern transition courses should be clinically orientated, address relevant skills, use experiential learning, and focus on practical tasks. Other aspects that are important in preparation of medical students for hospital practice cannot be addressed in a PRINT course, but major improvements are achievable by program-wide curriculum reform. PMID:24485072

Extended dynamic mode decomposition with dictionary learning: A data-driven adaptive spectral decomposition of the Koopman operator.

PubMed

Li, Qianxiao; Dietrich, Felix; Bollt, Erik M; Kevrekidis, Ioannis G

2017-10-01

Numerical approximation methods for the Koopman operator have advanced considerably in the last few years. In particular, data-driven approaches such as dynamic mode decomposition (DMD) 51 and its generalization, the extended-DMD (EDMD), are becoming increasingly popular in practical applications. The EDMD improves upon the classical DMD by the inclusion of a flexible choice of dictionary of observables which spans a finite dimensional subspace on which the Koopman operator can be approximated. This enhances the accuracy of the solution reconstruction and broadens the applicability of the Koopman formalism. Although the convergence of the EDMD has been established, applying the method in practice requires a careful choice of the observables to improve convergence with just a finite number of terms. This is especially difficult for high dimensional and highly nonlinear systems. In this paper, we employ ideas from machine learning to improve upon the EDMD method. We develop an iterative approximation algorithm which couples the EDMD with a trainable dictionary represented by an artificial neural network. Using the Duffing oscillator and the Kuramoto Sivashinsky partical differential equation as examples, we show that our algorithm can effectively and efficiently adapt the trainable dictionary to the problem at hand to achieve good reconstruction accuracy without the need to choose a fixed dictionary a priori. Furthermore, to obtain a given accuracy, we require fewer dictionary terms than EDMD with fixed dictionaries. This alleviates an important shortcoming of the EDMD algorithm and enhances the applicability of the Koopman framework to practical problems.

21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

21 CFR 225.1 - Current good manufacturing practice.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

21 CFR 26.15 - Monitoring continued equivalence.

Code of Federal Regulations, 2010 CFR

2010-04-01

... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM... COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.15 Monitoring... number of joint inspections; and the conduct of common training sessions. ...

21 CFR 26.15 - Monitoring continued equivalence.

Code of Federal Regulations, 2011 CFR

2011-04-01

... MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM... COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.15 Monitoring... number of joint inspections; and the conduct of common training sessions. ...

Evaluation of high fidelity patient simulator in assessment of performance of anaesthetists.

PubMed

Weller, J M; Bloch, M; Young, S; Maze, M; Oyesola, S; Wyner, J; Dob, D; Haire, K; Durbridge, J; Walker, T; Newble, D

2003-01-01

There is increasing emphasis on performance-based assessment of clinical competence. The High Fidelity Patient Simulator (HPS) may be useful for assessment of clinical practice in anaesthesia, but needs formal evaluation of validity, reliability, feasibility and effect on learning. We set out to assess the reliability of a global rating scale for scoring simulator performance in crisis management. Using a global rating scale, three judges independently rated videotapes of anaesthetists in simulated crises in the operating theatre. Five anaesthetists then independently rated subsets of these videotapes. There was good agreement between raters for medical management, behavioural attributes and overall performance. Agreement was high for both the initial judges and the five additional raters. Using a global scale to assess simulator performance, we found good inter-rater reliability for scoring performance in a crisis. We estimate that two judges should provide a reliable assessment. High fidelity simulation should be studied further for assessing clinical performance.

Constellation Stretch Goals: Review of Industry Inputs

NASA Technical Reports Server (NTRS)

Lang, John

2006-01-01

Many good ideas received based on industry experience: a) Shuttle operations; b) Commercial aircraft production; c) NASA's historical way of doing business; d) Military and commercial programs. Aerospace performed preliminary analysis: a) Potential savings; b) Cost of implementation; c) Performance or other impact/penalties; d) Roadblocks; e) Unintended consequences; f) Bottom line. Significant work ahead for a "Stretch Goal"to become a good, documented requirement: 1) As a group, the relative "value" of goals are uneven; 2) Focused analysis on each goal is required: a) Need to ensure that a new requirement produces the desired consequence; b) It is not certain that some goals will not create problems elsewhere. 3) Individual implementation path needs to be studied: a) Best place to insert requirement (what level, which document); b) Appropriate wording for the requirement. Many goals reflect "best practices" based on lessons learned and may have value beyond near-term CxP requirements process.

Evaluation of three-dimensional printing for internal fixation of unstable pelvic fracture from minimal invasive para-rectus abdominis approach: a preliminary report.

PubMed

Zeng, Canjun; Xiao, Jidong; Wu, Zhanglin; Huang, Wenhua

2015-01-01

The aim of this study is to evaluate the efficacy and feasibility of three-dimensional printing (3D printing) assisted internal fixation of unstable pelvic fracture from minimal invasive para-rectus abdominis approach. A total of 38 patients with unstable pelvic fractures were analyzed retrospectively from August 2012 to February 2014. All cases were treated operatively with internal fixation assisted by three-dimensional printing from minimal invasive para-rectus abdominis approach. Both preoperative CT and three-dimensional reconstruction were performed. Pelvic model was created by 3D printing. Data including the best entry points, plate position and direction and length of screw were obtained from simulated operation based on 3D printing pelvic model. The diaplasis and internal fixation were performed by minimal invasive para-rectus abdominis approach according to the optimized dada in real surgical procedure. Matta and Majeed score were used to evaluate currative effects after operation. According to the Matta standard, the outcome of the diaplasis achieved 97.37% with excellent and good. Majeed assessment showed 94.4% with excellent and good. The imageological examination showed consistency of internal fixation and simulated operation. The mean operation time was 110 minutes, mean intraoperative blood loss 320 ml, and mean incision length 6.5 cm. All patients have achieved clinical healing, with mean healing time of 8 weeks. Three-dimensional printing assisted internal fixation of unstable pelvic fracture from minimal invasive para-rectus abdominis approach is feasible and effective. This method has the advantages of trauma minimally, bleeding less, healing rapidly and satisfactory reduction, and worthwhile for spreading in clinical practice.

Educational Method of Engineering Ethics Aiming for Comprehensive Understanding

NASA Astrophysics Data System (ADS)

Yasui, Mitsukuni; Fujiki, Hiroyuki; Aoyagi, Manabu; Sugata, Noriyuki; Hayasaka, Narihito

We have proposed the omnibus style to teach an engineering ethics program. This paper showed the essentials to practice the class. The engineering ethics program is constituted with the factors; grade, subject, objective even if it is operated by some themes and teachers in the style of omnibus. Also, teachers have to select the cases which have dilemma of the engineer and the good effect. And they should teach how to analyze the case. Evaluation of student activity must be made up by versatile style according to objective. And student is recommended to understand the relation of activity and object.

Paediatric day-case neurosurgery in a resource challenged setting: Pattern and practice

PubMed Central

Owojuyigbe, Afolabi Muyiwa; Komolafe, Edward O.; Adenekan, Anthony T.; Dada, Muyiwa A.; Onyia, Chiazor U.; Ogunbameru, Ibironke O.; Owagbemi, Oluwafemi F.; Talabi, Ademola O.; Faponle, Fola A.

2016-01-01

Background: It has been generally observed that children achieve better convalescence in the home environment especially if discharged same day after surgery. This is probably due to the fact that children generally tend to feel more at ease in the home environment than in the hospital setting. Only few tertiary health institutions provide routine day-case surgery for paediatric neurosurgical patients in our sub-region. Objective: To review the pattern and practice of paediatric neurosurgical day-cases at our hospital. Patients and Methods: A prospective study of all paediatric day-case neurosurgeries carried out between June 2011 and June 2014. Results: A total of 53 patients (34 males and 19 females) with age ranging from 2 days to 14 years were seen. Majority of the patients (77.4%) presented with congenital lesions, and the most common procedure carried out was spina bifida repair (32%) followed by ventriculoperitoneal shunt insertion (26.4%) for hydrocephalus. Sixty-eight percentage belonged to the American Society of Anesthesiologists physical status class 2, whereas the rest (32%) belonged to class 1. General anaesthesia was employed in 83% of cases. Parenteral paracetamol was used for intra-operative analgesia for most of the patients. Two patients had post-operative nausea and vomiting and were successfully managed. There was no case of emergency re-operation, unplanned admission, cancellation or mortality. Conclusion: Paediatric day-case neurosurgery is feasible in our environment. With careful patient selection and adequate pre-operative preparation, good outcome can be achieved. PMID:27251657

[Good practices and techniques for prevention of accidents at work and occupational diseases. New database of Inail].

PubMed

Bindi, L; Ossicini, A

2007-01-01

The project "The publication of good practices and good techniques for prevention" is one the priorities of nail. This computerized system for the collection of good practices and standards of Good Technology is aimed to health and safety of workers. The basic objective of the database is to provide a valuable tool, usable, dynamic and implemented, in order to facilitate and direct the access to BP and BT it by people responsible for SSL. At the same time constitutes a tool strategically important for enterprises (especially SMEs) in terms of technological innovation and competitiveness, related to the prevention, safety and health of workers. The realization of this project has involved many of the professionals (chemists, engineers, doctors, biologists, geologists, etc.), and everyone gives his intake of qualified professional competence.

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.

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…

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…

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…

Knowledge, Attitudes and Practices Regarding Risk to Human Infection due to Mycobacterium bovis among Cattle Farming Communities in Western Uganda.

PubMed

Kazoora, H B; Majalija, S; Kiwanuka, N; Kaneene, J B

2016-12-01

A cross-sectional study involving multistage cluster sampling was undertaken in Kashari county, Mbarara district, western Uganda, in which quantitative and qualitative approaches were utilized to determine the knowledge, attitudes and practices regarding risk of human infection with zoonotic tuberculosis due to Mycobacterium bovis among cattle farmers. Of 496 respondents, 50% were farm owners and 50% herdsmen. Males were 70.9% of all the study participants. Among these, 37.5% had good knowledge, 41.4% had positive attitudes and 75.2% good practices regarding zoonotic tuberculosis. In the multivariable model, good knowledge was associated with having ever received health education, spending more than 5 years keeping cattle, having heard of cattle condemned at the abattoir due to tuberculosis and marital status. Positive attitudes were associated with having ever received health education, having heard of cattle condemned at the abattoir due to tuberculosis and being a farm owner versus being a herdsman. Good practices were associated with health education and good knowledge of the disease. Overall, knowledge and attitudes towards zoonotic tuberculosis due to M. bovis in humans was found to be low. While the majority of the respondents reported good practices, there were some still consuming raw milk and its products, which may predispose them to infection and indicates the need for greater outreach for zoonotic tuberculosis education. © 2016 Blackwell Verlag GmbH.

Reproducibility of the index of orthognathic functional treatment need scores derived from plaster study casts and their three-dimensional digital equivalents: a pilot study.

PubMed

McCrory, Emma; McGuinness, Niall Jp; Ulhaq, Aman

2018-06-01

To determine the reproducibility of Index of Orthognathic Functional Treatment Need (IOFTN) scores derived from plaster casts and their three-dimensional (3D) digital equivalents. Pilot study, prospective analytical. UK hospital orthodontic department. Thirty casts and their digital equivalents, representing the pre-treatment malocclusions of patients requiring orthodontic-orthognathic surgical treatment, were scored by four clinicians using IOFTN. Casts were scanned using a 3Shape digital scanner and 3D models produced using OrthoAnalyzer TM (3Shape Ltd, Copenhagen, Denmark). Examiners independently determined the IOFTN scores for the casts and digital models, to test their inter- and intra-operator reliability using weighted Kappa scores. Intra-operator agreement with IOFTN major categories (1-5: treatment need) was very good for plaster casts (0.83-0.98) and good-very good for digital models (0.78-0.83). Inter-operator agreement was moderate-very good for casts (0.58-0.82) and good-very good for digital models (0.65-0.92). Intra-operator agreement with IOFTN sub-categories (1-14: feature of malocclusion) was good-very good for casts (0.70-0.97) and digital models (0.80-0.94). Inter-operator agreement was moderate-good for casts (0.53-0.77); and moderate-very good for the digital models (0.58-0.90). Digital models are an acceptable alternative to plaster casts for examining the malocclusion of patients requiring combined orthodontic-orthognathic surgical treatment and determining treatment need.

Good practices : incorporating safety into resurfacing and restoration projects

DOT National Transportation Integrated Search

2006-12-01

Integrating safety improvements into resurfacing and restoration projects is a subject of long-standing interest by Federal, State, and local transportation agencies. A Scan Tour was conducted to identify and subsequently observe good practices in th...

The principles and best practice of question writing for postgraduate examinations.

PubMed

Hayes, Kevin; McCrorie, Peter

2010-12-01

Postgraduate medical education has changed enormously in the last 10 years presenting huge logistical challenges for local, regional and national organisations. Assessment is under change in line with major revisions of postgraduate curricula. Old methods of assessment are changing to newer evidence-based methods supported by ongoing research into good practice. This review examines the purpose and practical considerations of written assessment, the pros and cons of different assessment methods and how good practice can be evaluated and quality assured. Good quality assessment comes at a cost in terms of time and money, and organisations need to invest in their assessment strategies to ensure the highest possible standards. Copyright © 2010 Elsevier Ltd. All rights reserved.

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.

Identifying areas of weakness in thoracic surgery residency training: a comparison of the perceptions of residents and program directors.

PubMed

Edwards, Janet P; Schofield, Adam; Paolucci, Elizabeth Oddone; Schieman, Colin; Kelly, Elizabeth; Servatyari, Ramin; Dixon, Elijah; Ball, Chad G; Grondin, Sean C

2014-01-01

To identify core thoracic surgery procedures that require increased emphasis during thoracic surgery residency for residents to achieve operative independence and to compare the perspectives of residents and program directors in this regard. A modified Delphi process was used to create a survey that was distributed electronically to all Canadian thoracic surgery residents (12) and program directors (8) addressing the residents' ability to perform 19 core thoracic surgery procedures independently after the completion of residency. Residents were also questioned about the adequacy of their operative exposure to these 19 procedures during their residency training. A descriptive summary including calculations of frequencies and proportions was conducted. The perceptions of the 2 groups were then compared using the Fisher exact test employing a Bonferroni correction. The relationship between residents' operative exposure and their perceived operative ability was explored in the same fashion. The response rate was 100% for residents and program directors. No statistical differences were found between residents' and program directors' perceptions of residents' ability to perform the 19 core procedures independently. Both groups identified lung transplantation, first rib resection, and extrapleural pneumonectomy as procedures for which residents were not adequately prepared to perform independently. Residents' subjective ratings of operative exposure were in good agreement with their reported operative ability for 13 of 19 procedures. This study provides new insight into the perceptions of thoracic surgery residents and their program directors regarding operative ability. This study points to good agreement between residents and program directors regarding residents' surgical capabilities. This study provides information regarding potential weaknesses in thoracic surgery training, which may warrant an examination of the curricula of existing programs as well as a reconsideration of what the scope of practice of a general thoracic surgeon should entail. © 2013 Published by Association of Program Directors in Surgery on behalf of Association of Program Directors in Surgery.

Considering the health care entity C corporation conversion to tax pass-through entity status.

PubMed

Reilly, Robert F

2012-01-01

The double taxation of C corporation income from operations and from the ultimate sale of its assets makes the C corporation an inefficient tax status for many health care entities. At the time of this writing, the changes in the federal tax law that are scheduled to take effect in 2013 will increase this level of double-taxation inefficiency. The owners of a C corporation practice can avoid the C corporation status tax inefficiency by converting the practice to either (1) S corporation status or (2) LLC status. The conversion of the health care C corporation to an S corporation may be accomplished without a current tax cost. However, the conversion of a health care C corporation to an LLC status can result in a current tax at both the corporation level and the shareholder level. Nonetheless, the current conversion tax cost may be less than the future tax cost (1) of operating the practice as a C corporation and incurring double taxation at what may be higher tax rates or (2) of incurring the higher tax cost (or reduced price) on the ultimate disposition of the practice assets and the attendant double taxation of the appreciation in the value of the practice assets. Since individual income tax rates on qualifying dividends from C corporations and on capital gains are currently at very low rates, this may be a good time for C corporation practice owners to consider the costs and benefits of a conversion to either S corporation status or LLC status. The practice owners should consult with their accounting, legal, and valuation advisors in order to consider all of the costs and benefits of a possible corporate tax status conversion. An estimation of both the costs and benefits of the corporate tax status conversion depends on the concluded fair market values of the medical practice, dental practice, or other health care entity assets. And, that practice asset appraisal should encompass all of the practice assets, both tangible assets and intangible assets.

Why don't Practitioners use Reservoir Optimization Methods? Results from a Survey of UK Water Managers

NASA Astrophysics Data System (ADS)

Dobson, B.; Pianosi, F.; Wagener, T.

2016-12-01

Extensive scientific literature exists on the study of how operation decisions in water resource systems can be made more effectively through the use of optimization methods. However, to the best of the authors' knowledge, there is little in the literature on the implementation of these optimization methods by practitioners. We have performed a survey among UK reservoir operators to assess the current state of method implementation in practice. We also ask questions to assess the potential for implementation of operation optimization. This will help academics to target industry in their current research, identify any misconceptions in industry about the area and open new branches of research for which there is an unsatisfied demand. The UK is a good case study because the regulatory framework is changing to impose "no build" solutions for supply issues, as well as planning across entire water resource systems rather than individual components. Additionally there is a high appetite for efficiency due to the water industry's privatization and most operators are part of companies that control multiple water resources, increasing the potential for cooperation and coordination.

Satellite-aided mobile communications limited operational test in the trucking industry

NASA Technical Reports Server (NTRS)

Anderson, R. E.; Frey, R. L.; Lewis, J. R.

1980-01-01

An experiment with NASA's ATS-6 satellite, that demonstrates the practicality of satellite-aided land mobile communications is described. Satellite communications equipment for the experiment was designed so that it would be no more expensive, when mass produced, than conventional two-way mobile radio equipment. It embodied the operational features and convenience of present day mobile radios. Vehicle antennas 75 cm tall and 2 cm in diameter provided good commercial quality signals to and from trucks and jeeps. Operational applicability and usage data were gathered by installing the radio equipment in five long-haul tractor-trailer trucks and two Air Force search and rescue jeeps. Channel occupancy rates are reported. Air Force personnel found the satellite radio system extremely valuable in their search and rescue mission during maneuvers and actual rescue operations. Propagation data is subjectively analyzed and over 4 hours of random data is categorized and graded as to signal quality on a second by second basis. Trends in different topographic regions are reported. An overall communications reliability of 93% was observed despite low satellite elevation angles ranging from 9 to 24 degrees.

Cattle and the oil and gas industry in Alberta: A literature review with recommendations for environmental management

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1996-12-31

The purpose of this report is to bring together a review of published information on the potential effects of upstream oil and gas industry operations on the cattle industry in Alberta, some indication of the probability of occurrence of these effects, and recommendations on how they might be avoided or mitigated. Based on reviews of scientific papers and industry good-practice manuals, the report describes: The sources and quantities of environmental contaminants generated by Alberta`s oil and gas industry, including normal operations, accidental releases, and the effects of aging infrastructure; the chemical composition of the products, materials, and wastes associated withmore » the industry; the fate and transport of the contaminants through air, water, and soil; cattle operations in Alberta; the toxicology of oil and gas industry contaminants in cattle; and selected Alberta case studies of accidental releases and planned experiments. Conclusions and recommendations deal with critical information gaps and strategies for the sustainable management of cattle and oil/gas operations in the province.« less

21 CFR 26.1 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN... regulatory systems means that the systems are sufficiently comparable to assure that the process of... require that the respective regulatory systems have identical procedures. (c) Good Manufacturing Practices...

40 CFR 68.73 - Mechanical integrity.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) CHEMICAL ACCIDENT PREVENTION PROVISIONS Program 3 Prevention Program § 68.73 Mechanical integrity. (a... accepted good engineering practices. (3) The frequency of inspections and tests of process equipment shall be consistent with applicable manufacturers' recommendations and good engineering practices, and more...