Science.gov

Sample records for good manufacture practices

  1. Highlights of Good Manufacturing Practice in Japan.

    PubMed

    Morita, K

    1990-01-01

    Good Manufacturing Practice (GMP) in the pharmaceutical industry originated in the United States. Japan, having absorbed many things from the U.S., is actively seeking to establish Good Manufacturing Practice to match the pharmaceutical manufacturing climate in Japan. Several of the themes which highlight Japanese GMP efforts are presented below.

  2. 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...

  3. 21 CFR 110.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  4. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  5. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  6. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  7. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  8. 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...

  9. 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,...

  10. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  11. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  12. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  13. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  14. 21 CFR 129.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 129.1 Section... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as the... manufacturing practice to assure that bottled drinking water is safe and that it has been processed,...

  15. 21 CFR 129.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 129.1 Section... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as the... manufacturing practice to assure that bottled drinking water is safe and that it has been processed,...

  16. 21 CFR 129.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 129.1 Section... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as the... manufacturing practice to assure that bottled drinking water is safe and that it has been processed,...

  17. 21 CFR 110.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 110.5 Section 110.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR...

  18. 21 CFR 110.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 110.5 Section 110.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR...

  19. 21 CFR 110.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 110.5 Section 110.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR...

  20. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  1. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  2. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  3. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  4. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  5. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  6. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  7. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  8. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  9. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  10. 21 CFR 123.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 123.5 Section 123.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities,...

  11. 21 CFR 123.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 123.5 Section 123.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities,...

  12. 21 CFR 123.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 123.5 Section 123.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities,...

  13. 21 CFR 123.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 123.5 Section 123.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities,...

  14. 21 CFR 114.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  15. 21 CFR 114.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  16. 21 CFR 114.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  17. 21 CFR 114.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  18. 21 CFR 114.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  19. Application of ISO 9002 and FDA's good manufacturing practices to general chemical manufacturing.

    PubMed

    Kauffman, J M; Weiler, E D

    1992-06-01

    Two manufacturing standards are discussed and compared, namely, the U.S. Food and Drug Administration's Good Manufacturing Practices and the International Standards Organization 9000 (ISO 9000) series. Conclusions are drawn relative to quality improvement strategies.

  20. 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 123.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current...

  1. 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

  2. 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.

  3. 78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

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

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

    SciTech Connect

    Iveson, Steven W.

    2014-11-01

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

  5. 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...

  6. 21 CFR 210.1 - Status of current good manufacturing practice regulations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  7. 21 CFR 210.1 - Status of current good manufacturing practice regulations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  8. 21 CFR 210.1 - Status of current good manufacturing practice regulations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  9. 21 CFR 210.1 - Status of current good manufacturing practice regulations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  10. 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...

  11. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  12. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  13. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  14. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false What is current good manufacturing practice for... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET...

  15. 21 CFR 129.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) FOOD FOR HUMAN CONSUMPTION PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER General Provisions § 129.1... manufacturing practice to assure that bottled drinking water is safe and that it has been processed, bottled..., methods, practices, and controls used in the processing, bottling, holding, and shipping of...

  16. 21 CFR 129.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) FOOD FOR HUMAN CONSUMPTION PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER General Provisions § 129.1... manufacturing practice to assure that bottled drinking water is safe and that it has been processed, bottled..., methods, practices, and controls used in the processing, bottling, holding, and shipping of...

  17. Burn patient care lost in good manufacturing practices?

    PubMed Central

    Dimitropoulos, G.; Jafari, P.; de Buys Roessingh, A.; Hirt-Burri, N.; Raffoul, W.; Applegate, L.A.

    2016-01-01

    Summary Application of cell therapies in burn care started in the early 80s in specialized hospital centers world-wide. Since 2007, cell therapies have been considered as “Advanced Therapy Medicinal Products” (ATMP), so classified by European Directives along with associated Regulations by the European Parliament. Consequently, regulatory changes have transformed the standard linear clinical care pathway into a more complex one. It is important to ensure the safety of cellular therapies used for burn patients and to standardize as much as possible the cell sources and products developed using cell culture procedures. However, we can definitely affirm that concentrating the bulk of energy and resources on the implementation of Good Manufacturing Practice (GMP) alone will have a major negative impact on the care of severely burned patients world-wide. Developing fully accredited infrastructures and training personnel (required by the new directives), along with obtaining approval for clinical trials to go ahead, can be a lengthy process.We discuss whether or not these patients could benefit from cell therapies provided by standard in-hospital laboratories, thus avoiding having to meet rigid regulations concerning the use of industrial pharmaceutical products. “Hospital Exemption” could be a preferred means to offer burn patients a customized and safe product, as many adaptations may be required throughout their treatment pathway. Patients who are in need of rapid treatment will be the ones to suffer the most from regulations intended to help them. PMID:28149232

  18. Burn patient care lost in good manufacturing practices?

    PubMed

    Dimitropoulos, G; Jafari, P; de Buys Roessingh, A; Hirt-Burri, N; Raffoul, W; Applegate, L A

    2016-06-30

    Application of cell therapies in burn care started in the early 80s in specialized hospital centers world-wide. Since 2007, cell therapies have been considered as "Advanced Therapy Medicinal Products" (ATMP), so classified by European Directives along with associated Regulations by the European Parliament. Consequently, regulatory changes have transformed the standard linear clinical care pathway into a more complex one. It is important to ensure the safety of cellular therapies used for burn patients and to standardize as much as possible the cell sources and products developed using cell culture procedures. However, we can definitely affirm that concentrating the bulk of energy and resources on the implementation of Good Manufacturing Practice (GMP) alone will have a major negative impact on the care of severely burned patients world-wide. Developing fully accredited infrastructures and training personnel (required by the new directives), along with obtaining approval for clinical trials to go ahead, can be a lengthy process.We discuss whether or not these patients could benefit from cell therapies provided by standard in-hospital laboratories, thus avoiding having to meet rigid regulations concerning the use of industrial pharmaceutical products. "Hospital Exemption" could be a preferred means to offer burn patients a customized and safe product, as many adaptations may be required throughout their treatment pathway. Patients who are in need of rapid treatment will be the ones to suffer the most from regulations intended to help them.

  19. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  20. 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...

  1. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  2. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  3. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  4. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Small Business Entities on Current Good... a guidance for small business entities entitled ``PET Drugs--Current Good Manufacturing Practice... entitled ``PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.''...

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

    PubMed

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

    2013-01-01

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

  6. Proposed rule: current good manufacturing practice in manufacturing, packing, or holding dietary ingredients and dietary supplements.

    PubMed

    Melethil, Srikumaran

    2006-03-27

    The Dietary Supplement Health and Education Act (DSHEA) was enacted in October 1994 to promote the health of Americans by ensuring easier access to safe dietary supplements. Many supplements such as vitamins, minerals, herbs and amino acids have been reported to be helpful in chronic conditions (i.e., heart disease, cancer and osteoporosis). Under DSHEA, dietary supplements can be marketed without prior FDA approval; the burden is on this agency to show that a marketed dietary supplement is unsafe. However, DSHEA retained the FDA's authority to issue regulations that require the manufacture of dietary supplements be in compliance with current good manufacturing practice (cGMP) standards, which are needed to ensure their quality. Several quality-related concerns of marketed dietary supplements that came to light since the passage of DSHEA prompted the FDA in 2003 to propose rules for cGMP for the manufacture, packaging and holding (storage) of dietary supplements. This review will present the highlights of these proposed rules, focusing on the legislative history of DSHEA, rationale for proposing cGMPs along with a general discussion of the specific requirements. Given the voluminous nature of the specific details, the reader is directed to the pertinent FDA publications for details. In this analysis, selected scientific and legal issues are also discussed to promote a better understanding and implications of these rules.

  7. 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

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

    PubMed

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

    2015-01-01

    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.

  9. 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.

  10. 75 FR 78715 - Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ... HUMAN SERVICES Food and Drug Administration Small Entity Compliance Guide: Current Good Manufacturing... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA....regulations.gov . Submit written comments on the SECG to the Division of Dockets Management (HFA-305),...

  11. 78 FR 4307 - Current Good Manufacturing Practice Requirements for Combination Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 4 Current Good Manufacturing Practice...: The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good...? (Sec. 4.1) C. How does FDA define key terms and phrases in this subpart? (Sec. 4.2) D. What...

  12. Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. Final rule.

    PubMed

    2016-11-18

    The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements. These requirements are intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container. FDA is also revising an existing regulation that conditionally exempts certain medical gases from certain otherwise-applicable labeling requirements in order to add oxygen and nitrogen to the list of gases subject to the exemption, and to remove cyclopropane and ethylene from the list.

  13. 76 FR 82308 - Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products... Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and... for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)''...

  14. Preparation of intravenous cholesterol tracer using current good manufacturing practices1[S

    PubMed Central

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

    2015-01-01

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

  15. 78 FR 64735 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-29

    ...The Food and Drug Administration (FDA) is proposing regulations for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish requirements for current good manufacturing practice in manufacturing, processing, packing, and holding of animal food. FDA also is proposing regulations to require that certain facilities......

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed

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

    2011-04-01

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

  18. Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction.

    PubMed

    Sheth-Shah, Radhika; Vernon, Amanda J; Seetharaman, Shankar; Neale, Michael H; Daniels, Julie T

    2016-04-01

    In the past decade, stem cell therapy has been increasingly employed for the treatment of various diseases. Subsequently, there has been a great interest in the manufacture of stem cells under good manufacturing practice, which is required by law for their use in humans. The cells for sight Stem Cell Therapy Research Unit, based at UCL Institute of Ophthalmology, delivers somatic cell-based and tissue-engineered therapies to patients suffering from blinding eye diseases at Moorfields Eye Hospital (London, UK). The following article is based on our experience in the conception, design, construction, validation and manufacturing within a good manufacturing practice manufacturing facility based in the UK. As such the regulations can be extrapolated to the 28 members stated within the EU. However, the principles may have a broad relevance outside the EU.

  19. 78 FR 24691 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 RIN 0910-AG36 Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Extension of Comment Periods AGENCY: Food and Drug Administration,...

  20. 78 FR 11611 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 RIN 0910-AG36 Current Good Manufacturing Practice and Hazard Analysis and Risk- Based...: Food and Drug Administration, HHS. ACTION: Proposed rule; extension of comment period for...

  1. 78 FR 69604 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 RIN 0910-AG36 Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Extension of Comment Periods AGENCY: Food and Drug Administration,...

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

    PubMed

    2014-06-10

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

  3. 21 CFR 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... manufacturing practice requirements for a co-packaged or single-entity combination product? 4.4 Section 4.4 Food... comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product? (a) Under this subpart, for single entity or co-packaged combination products,...

  4. 21 CFR 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... manufacturing practice requirements for a co-packaged or single-entity combination product? 4.4 Section 4.4 Food... comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product? (a) Under this subpart, for single entity or co-packaged combination products,...

  5. Impact of current good manufacturing practices and emission regulations and guidances on the discharge of pharmaceutical chemicals into the environment from manufacturing, use, and disposal.

    PubMed Central

    Velagaleti, Ranga; Burns, Philip K; Gill, Michael; Prothro, James

    2002-01-01

    The current Good Manufacturing Practice (cGMP) and effluent emission (use and disposal) regulations of the U.S. Food and Drug Administration (FDA) and manufacturing effluent discharge and emission regulations of the U.S. Environmental Protection Agency (U.S. EPA) require contained manufacture, use, and disposal of pharmaceuticals with the goal of minimizing the release of pharmaceutical chemicals into the environment. However, debate has recently arisen in several scientific forums over whether these regulations adequately protect human and environmental health from the new pharmaceutical drugs introduced each year into the marketplace and the multitude of existing products, each with many distinct biochemical modes of actions. To address this issue, it is important to understand the relevance of current cGMP regulations and emission regulations that have a direct bearing on the releases of pharmaceutical chemicals into the environment during the manufacture, use, and disposal of active pharmaceutical ingredients (drug substances) and drug products. This knowledge may help us assess the quantity of residues that may be released into the environment. Additionally, the information on physical, chemical, and degradation and sorption properties of the pharmaceutical chemicals may help determine the net residue levels that could persist in the environment to evaluate if such residues have any bearing on human and environmental health. The scientific and regulatory aspects of issues related to the manufacture, use, and disposal of pharmaceutical chemicals are discussed in this article, with special emphasis on potential environmental exposure pathways during the life cycle of an active pharmaceutical ingredient or drug product. The mechanisms of degradation (transformation or depletion) and dilution of pharmaceutical residues that may be released into aquatic or terrestrial environmental compartments are described. Such degradation and dilution of pharmaceutical

  6. Bioprocessing of plant-derived virus-like particles of Norwalk virus capsid protein under current Good Manufacture Practice regulations.

    PubMed

    Lai, Huafang; Chen, Qiang

    2012-03-01

    Despite the success in expressing a variety of subunit vaccine proteins in plants and the recent stride in improving vaccine accumulation levels by transient expression systems, there is still no plant-derived vaccine that has been licensed for human use. The lack of commercial success of plant-made vaccines lies in several technical and regulatory barriers that remain to be overcome. These challenges include the lack of scalable downstream processing procedures, the uncertainty of regulatory compliance of production processes, and the lack of demonstration of plant-derived products that meet the required standards of regulatory agencies in identity, purity, potency and safety. In this study, we addressed these remaining challenges and successfully demonstrate the ability of using plants to produce a pharmaceutical grade Norwalk virus (NV) vaccine under current Good Manufacture Practice (cGMP) guidelines at multiple gram scales. Our results demonstrate that an efficient and scalable extraction and purification scheme can be established for processing virus-like particles (VLPs) of NV capsid protein (NVCP). We successfully operated the upstream and downstream NVCP production processes under cGMP regulations. Furthermore, plant-derived NVCP VLP demonstrates the identity, purity, potency and safety that meet the preset release specifications. This material is being tested in a Phase I human clinical trial. This research provides the first report of producing a plant-derived vaccine at scale under cGMP regulations in an academic setting and an important step for plant-produced vaccines to become a commercial reality.

  7. Good manufacturing practice production of [68Ga]Ga-ABY-025 for HER2 specific breast cancer imaging

    PubMed Central

    Velikyan, Irina; Wennborg, Anders; Feldwisch, Joachim; Lindman, Henrik; Carlsson, Jörgen; Sörensen, Jens

    2016-01-01

    Therapies targeting human epidermal growth factor receptor type 2 (HER2) have revolutionized breast cancer treatment, but require invasive biopsies and rigorous histopathology for optimal patient stratification. A non-invasive and quantitative diagnostic method such as positron emission tomography (PET) for the pre-therapeutic determination of the presence and density of the HER2 would significantly improve patient management efficacy and treatment cost. The essential part of the PET methodology is the production of the radiopharmaceutical in compliance with good manufacturing practice (GMP). The use of generator produced positron emitting 68Ga radionuclide would provide worldwide accessibility of the agent. GMP compliant, reliable and highly reproducible production of [68Ga]Ga-ABY-025 with control over the product peptide concentration and amount of radioactivity was accomplished within one hour. Two radiopharmaceuticals were developed differing in the total peptide content and were validated independently. The specific radioactivity could be kept similar throughout the study, and it was 6-fold higher for the low peptide content radiopharmaceutical. Intrapatient comparison of the two peptide doses allowed imaging optimization. The high peptide content decreased the uptake in healthy tissue, in particular liver, improving image contrast. The later imaging time points enhanced the contrast. The combination of high peptide content radiopharmaceutical and whole-body imaging at 2 hours post injection appeared to be optimal for routine clinical use. PMID:27186441

  8. Developing Good Practices

    ERIC Educational Resources Information Center

    Fox, Sharon E.

    1972-01-01

    Discusses some good oral reading concepts that teachers should consider when developing new classroom practices, including: round robin reading, silent reading before oral reading, shared reading, etc. (NL)

  9. Raising the standard: changes to the Australian Code of Good Manufacturing Practice (cGMP) for human blood and blood components, human tissues and human cellular therapy products.

    PubMed

    Wright, Craig; Velickovic, Zlatibor; Brown, Ross; Larsen, Stephen; Macpherson, Janet L; Gibson, John; Rasko, John E J

    2014-04-01

    In Australia, manufacture of blood, tissues and biologicals must comply with the federal laws and meet the requirements of the Therapeutic Goods Administration (TGA) Manufacturing Principles as outlined in the current Code of Good Manufacturing Practice (cGMP). The Therapeutic Goods Order (TGO) No. 88 was announced concurrently with the new cGMP, as a new standard for therapeutic goods. This order constitutes a minimum standard for human blood, tissues and cellular therapeutic goods aimed at minimising the risk of infectious disease transmission. The order sets out specific requirements relating to donor selection, donor testing and minimisation of infectious disease transmission from collection and manufacture of these products. The Therapeutic Goods Manufacturing Principles Determination No. 1 of 2013 references the human blood and blood components, human tissues and human cellular therapy products 2013 (2013 cGMP). The name change for the 2013 cGMP has allowed a broadening of the scope of products to include human cellular therapy products. It is difficult to directly compare versions of the code as deletion of some clauses has not changed the requirements to be met, as they are found elsewhere amongst the various guidelines provided. Many sections that were specific for blood and blood components are now less prescriptive and apply to a wider range of cellular therapies, but the general overall intent remains the same. Use of 'should' throughout the document instead of 'must' allows flexibility for alternative processes, but these systems will still require justification by relevant logical argument and validation data to be acceptable to TGA. The cGMP has seemingly evolved so that specific issues identified at audit over the last decade have now been formalised in the new version. There is a notable risk management approach applied to most areas that refer to process justification and decision making. These requirements commenced on 31 May 2013 and a 12 month

  10. Influence of good manufacturing practices on the shelf life of refrigerated fillets of tilapia (Oreochromis niloticus) packed in modified atmosphere and gamma-irradiated

    PubMed Central

    Monteiro, Maria Lúcia Guerra; Mársico, Eliane Teixeira; Mano, Sérgio Borges; Teixeira, Claudia Emília; da Cruz Silva Canto, Anna Carolina Vilhena; de Carvalho Vital, Helio; Conte-Júnior, Carlos Adam

    2013-01-01

    This study evaluated the influence of good manufacturing practices (GMP) on the shelf life of refrigerated fillets of Nile tilapia (Oreochromis niloticus) packed in modified atmosphere packaging (MAP) and irradiated. In a first series of experiments, 120 tilapia fillets kept under controlled sanitary conditions were purchased from a fish market managed by a cooperative. A second lot totaling 200 tilapia fillets was obtained under controlled storage conditions from a pilot plant. The combined effects of MAP (40% CO2 and 60% N2) and irradiation (1.5 kGy) were investigated by monitoring physical and chemical (total volatile bases and pH), bacteriological (aerobic heterotrophic mesophilic and psychrophilic bacteria) and sensory (acceptance test) changes in the samples. The quality of samples decreased with storage time regardless of the treatment, remaining higher in fillets produced in the pilot plant in comparison with the commercially produced fillets. The observed shelf life of nonirradiated commercially produced fillets was only 3 days, compared to 8 days for those produced in the pilot plant, probably due to GMP in the latter. It was concluded that, even with a combination of proven conservation methods for meats, the adoption of good manufacturing practices still remains essential before, during, and after the filleting process in order to ensure the effectiveness of the entire treatment. PMID:24804034

  11. Influence of good manufacturing practices on the shelf life of refrigerated fillets of tilapia (Oreochromis niloticus) packed in modified atmosphere and gamma-irradiated.

    PubMed

    Monteiro, Maria Lúcia Guerra; Mársico, Eliane Teixeira; Mano, Sérgio Borges; Teixeira, Claudia Emília; da Cruz Silva Canto, Anna Carolina Vilhena; de Carvalho Vital, Helio; Conte-Júnior, Carlos Adam

    2013-07-01

    This study evaluated the influence of good manufacturing practices (GMP) on the shelf life of refrigerated fillets of Nile tilapia (Oreochromis niloticus) packed in modified atmosphere packaging (MAP) and irradiated. In a first series of experiments, 120 tilapia fillets kept under controlled sanitary conditions were purchased from a fish market managed by a cooperative. A second lot totaling 200 tilapia fillets was obtained under controlled storage conditions from a pilot plant. The combined effects of MAP (40% CO2 and 60% N2) and irradiation (1.5 kGy) were investigated by monitoring physical and chemical (total volatile bases and pH), bacteriological (aerobic heterotrophic mesophilic and psychrophilic bacteria) and sensory (acceptance test) changes in the samples. The quality of samples decreased with storage time regardless of the treatment, remaining higher in fillets produced in the pilot plant in comparison with the commercially produced fillets. The observed shelf life of nonirradiated commercially produced fillets was only 3 days, compared to 8 days for those produced in the pilot plant, probably due to GMP in the latter. It was concluded that, even with a combination of proven conservation methods for meats, the adoption of good manufacturing practices still remains essential before, during, and after the filleting process in order to ensure the effectiveness of the entire treatment.

  12. Good Clinical Practice Training

    PubMed Central

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

    2016-01-01

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

  13. 78 FR 64425 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-29

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16, 225, 500, 507, and 579 Current Good... Meeting on Proposed Rule AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meeting. SUMMARY: The Food and Drug Administration (FDA or we) is announcing three public meetings to discuss...

  14. Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan.

    PubMed

    Li, Tzu-Wei; Tu, Pei-Weng; Liu, Li-Ling; Wu, Shiow-Ing

    2015-01-01

    The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development.

  15. Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan

    PubMed Central

    Tu, Pei-Weng; Wu, Shiow-Ing

    2015-01-01

    The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development. PMID:26075255

  16. In situ cryopreservation of human embryonic stem cells in gas-permeable membrane culture cassettes for high post-thaw yield and good manufacturing practice.

    PubMed

    Amps, K J; Jones, M; Baker, D; Moore, H D

    2010-06-01

    The development of efficient and robust methods for the cryopreservation of human embryonic stem cells (hESCs) is important for the production of master and working cell banks for future clinical applications. Such methods must meet requirements of good manufacturing practice (GMP) and maintain genetic stability of the cell line. We investigated the culture of four Shef hESC lines in gas permeable 'culture cassettes' which met GMP compliance. hESCs adhered rapidly to the membrane and colonies displayed good proliferation and expansion. After 5-7 days of culture, hESCs were cryopreserved in situ using 10% dimethyl sulphoxide in foetal calf serum at approximately 1 degrees C/min. This method was compared with a control of standard flask culture and cryopreservation in vials. Post-thaw cassette culture displayed relative proliferation ratios (fold increase above flask/cryovial culture) of 114 (Shef 4), 8.2 (Shef 5), 195 (shef 6) and 17.5 (Shef 7). The proportion of cells expressing pluripotency markers after cryopreservation was consistently greater in cassette culture than for the control with the markers SSEA3 and SSEA4 exhibiting a significant increase (P> or =0.05). The efficiency of cell line culture in cassette was associated with the overall passage number of the cell line. The procedure enables cryopreservation of relatively large quantities of hESCs in situ, whilst returning high yields of viable, undifferentiated stem cells, thereby increasing capacity to scale up with greater efficacy.

  17. Production and validation of a good manufacturing practice grade human fibroblast line for supporting human embryonic stem cell derivation and culture

    PubMed Central

    2012-01-01

    Introduction The development of reproducible methods for deriving human embryonic stem cell (hESC) lines in compliance with good manufacturing practice (GMP) is essential for the development of hESC-based therapies. Although significant progress has been made toward the development of chemically defined conditions for the maintenance and differentiation of hESCs, efficient derivation of new hESCs requires the use of fibroblast feeder cells. However, GMP-grade feeder cell lines validated for hESC derivation are not readily available. Methods We derived a fibroblast cell line (NclFed1A) from human foreskin in compliance with GMP standards. Consent was obtained to use the cells for the production of hESCs and to generate induced pluripotent stem cells (iPSCs). We compared the line with a variety of other cell lines for its ability to support derivation and self-renewal of hESCs. Results NclFed1A supports efficient rates (33%) of hESC colony formation after explantation of the inner cell mass (ICM) of human blastocysts. This compared favorably with two mouse embryonic fibroblast (MEF) cell lines. NclFed1A also compared favorably with commercially available foreskin fibroblasts and MEFs in promoting proliferation and pluripotency of a number of existing and widely used hESCs. The ability of NclFed1A to maintain self-renewal remained undiminished for up to 28 population doublings from the master cell bank. Conclusions The human fibroblast line Ncl1Fed1A, produced in compliance with GMP standards and qualified for derivation and maintenance of hESCs, is a useful resource for the advancement of progress toward hESC-based therapies in regenerative medicine. PMID:22472092

  18. Practicing Good Habits, Grade 2.

    ERIC Educational Resources Information Center

    Nguyen Van Quan; And Others

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

  19. News: Good chemical manufacturing process criteria

    EPA Science Inventory

    This news column covers topics relating to manufacturing criteria, machine to machine technology, novel process windows, green chemistry indices, business resilience, immobilized enzymes, and Bt crops.

  20. Marketing manufactured housing under the ''Super Good Cents'' Program

    SciTech Connect

    Mohler, B.L.; Smith, S.A.

    1986-01-01

    The objective of this study is to propose a strategy for including manufactured housing (MH) in Bonneville Power Administration's Super Good Cents (SGC) Program. This report presents information on the site-built SGC program, the characterization of MH consumers, the options for including MH in the SGC program, and the recommendations for including MHs in the SGC program. The purposed strategy for including MHs in the SGC program is designed to reduce risks to manufacturers and dealers, stimulate demand, and allow for maximum flexibility.

  1. Good Laboratory Practice. Part 1. An Introduction

    ERIC Educational Resources Information Center

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

    2013-01-01

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

  2. Cloud manufacturing: from concept to practice

    NASA Astrophysics Data System (ADS)

    Ren, Lei; Zhang, Lin; Tao, Fei; Zhao, Chun; Chai, Xudong; Zhao, Xinpei

    2015-02-01

    The concept of cloud manufacturing is emerging as a new promising manufacturing paradigm, as well as a business model, which is reshaping the service-oriented, highly collaborative, knowledge-intensive and eco-efficient manufacturing industry. However, the basic concepts about cloud manufacturing are still in discussion. Both academia and industry will need to have a commonly accepted definition of cloud manufacturing, as well as further guidance and recommendations on how to develop and implement cloud manufacturing. In this paper, we review some of the research work and clarify some fundamental terminologies in this field. Further, we developed a cloud manufacturing systems which may serve as an application example. From a systematic and practical perspective, the key requirements of cloud manufacturing platforms are investigated, and then we propose a cloud manufacturing platform prototype, MfgCloud. Finally, a public cloud manufacturing system for small- and medium-sized enterprises (SME) is presented. This paper presents a new perspective for cloud manufacturing, as well as a cloud-to-ground solution. The integrated solution proposed in this paper, including the terminology, MfgCloud, and applications, can push forward this new paradigm from concept to practice.

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

    ERIC Educational Resources Information Center

    Bogotch, Ira E.

    1988-01-01

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

  4. Alternative Pathways to Apprenticeships. Good Practice Guide

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2015

    2015-01-01

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

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

    ERIC Educational Resources Information Center

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

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

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

    SciTech Connect

    1998-12-01

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

  7. Guide to good practices for communications

    SciTech Connect

    1998-12-01

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

  8. [Guidelines for good practice of sports activities].

    PubMed

    Scheen, A J; Crielaard, J M

    2001-05-01

    The present closing article summarizes some guidelines for the good practice of physical activities in order to develop and maintain cardiorespiratory and muscular fitness, and flexibility. Advice is given regarding the recommended quantity and quality of exercise in term of intensity, duration and frequency of training with the aim to optimize the risk/benefit ratio for health, in both aerobic endurance and resistance exercises. The crucial role of an appropriate warm-up and cool-down period, which would include flexibility exercises, is also emphasized. Finally, some practical examples illustrate this vademecum of physical activities.

  9. Guide to good practices for operations turnover

    SciTech Connect

    1998-12-01

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

  10. Editorial: A Note on Good Research Practice

    SciTech Connect

    Dooley, James J.

    2013-07-01

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

  11. Good laboratory practice and laboratory accreditation.

    PubMed

    Lawrence, J; McQuaker, N

    1993-12-01

    Principles of good laboratory practice (GLP) and laboratory accreditation programs, particularly as they pertain to the environmental sector, are reviewed. The multitude of programs is proving costly for many laboratories and there is mounting pressure to develop reciprocity agreements between programs and to consolidate nationally and internationally. Inclusion of GLP and laboratory accreditation requirements in government regulations is resulting in a significantly increased number of laboratories participating in these programs.

  12. Good Practices in Free-energy Calculations

    NASA Technical Reports Server (NTRS)

    Pohorille, Andrew; Jarzynski, Christopher; Chipot, Christopher

    2013-01-01

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

  13. Gluing Practice at Aircraft Manufacturing Plants

    NASA Technical Reports Server (NTRS)

    Truax, T R

    1928-01-01

    This report records observations and recommendations resulting from an inspection trip to representative aircraft manufacturing establishments and repair stations. This inspection was made for the Navy Department and was specifically in reference to gluing practice at the various places visited. The period of the visits was between November 23, 1926 and February 16, 1927.

  14. Good practices for quantitative bias analysis.

    PubMed

    Lash, Timothy L; Fox, Matthew P; MacLehose, Richard F; Maldonado, George; McCandless, Lawrence C; Greenland, Sander

    2014-12-01

    Quantitative bias analysis serves several objectives in epidemiological research. First, it provides a quantitative estimate of the direction, magnitude and uncertainty arising from systematic errors. Second, the acts of identifying sources of systematic error, writing down models to quantify them, assigning values to the bias parameters and interpreting the results combat the human tendency towards overconfidence in research results, syntheses and critiques and the inferences that rest upon them. Finally, by suggesting aspects that dominate uncertainty in a particular research result or topic area, bias analysis can guide efficient allocation of sparse research resources. The fundamental methods of bias analyses have been known for decades, and there have been calls for more widespread use for nearly as long. There was a time when some believed that bias analyses were rarely undertaken because the methods were not widely known and because automated computing tools were not readily available to implement the methods. These shortcomings have been largely resolved. We must, therefore, contemplate other barriers to implementation. One possibility is that practitioners avoid the analyses because they lack confidence in the practice of bias analysis. The purpose of this paper is therefore to describe what we view as good practices for applying quantitative bias analysis to epidemiological data, directed towards those familiar with the methods. We focus on answering questions often posed to those of us who advocate incorporation of bias analysis methods into teaching and research. These include the following. When is bias analysis practical and productive? How does one select the biases that ought to be addressed? How does one select a method to model biases? How does one assign values to the parameters of a bias model? How does one present and interpret a bias analysis?. We hope that our guide to good practices for conducting and presenting bias analyses will encourage

  15. Intravenous therapy: a guide to good practice.

    PubMed

    Scales, Katie

    This article provides an overview of the principles of good practice that underpin intravenous (IV) therapy. The indications for choosing the IV route and selecting an appropriate vascular access device (VAD) are explained. Common insertion sites for VAD placement and the care and management of VADs are reviewed. Infection control aspects of IV therapy are be highlighted, including the management of IV equipment and the importance of the nurse's role in the prevention of infection associated with IV therapy. Common complications of IV therapy are explained and strategies suggested for their prevention. The article addresses the issues associated with general IV therapy, it does not address specialist subjects such as parenteral nutrition, chemotherapy or blood transfusion.

  16. Good operating practices cut water pollution

    SciTech Connect

    West, D.E.

    1982-07-12

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

  17. 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

  18. Changing Public Perception in Wisconsin: Manufacturing a "Good Life"

    ERIC Educational Resources Information Center

    Jorgensen, Haley

    2006-01-01

    Careers in manufacturing are high-wage and high-tech. Yet, a future workforce shortage may be on the horizon. It appears a negative public perception--one that brings to mind low wages, assembly-line work and lay-offs--is thwarting young adults from pursuing manufacturing careers across the country. This article describes how the Wisconsin…

  19. Good practice in multimedia courseware development.

    PubMed

    Schulz, C

    1998-01-01

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

  20. Seven Principles for Good Practice in Legal Education: Principle 2: Good Practice Encourages Cooperation among Students.

    ERIC Educational Resources Information Center

    Dominguez, David

    1999-01-01

    One of a series of articles on principles of good practice in legal education, this article focuses on the importance of encouraging cooperation among students. Considers the value of the learning community and the relationship of cooperative learning and academic excellence. Includes examples of cooperative learning in a variety of law school…

  1. 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…

  2. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 19 2010-07-01 2010-07-01 false Application of good engineering... Application of good engineering judgment to manufacturers' decisions. (a) The manufacturer shall exercise good engineering judgment in making all decisions called for under this subpart, including but not limited...

  3. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 20 2013-07-01 2013-07-01 false Application of good engineering... Application of good engineering judgment to manufacturers' decisions. (a) The manufacturer shall exercise good engineering judgment in making all decisions called for under this subpart, including but not limited...

  4. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 20 2012-07-01 2012-07-01 false Application of good engineering... Application of good engineering judgment to manufacturers' decisions. (a) The manufacturer shall exercise good engineering judgment in making all decisions called for under this subpart, including but not limited...

  5. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 19 2014-07-01 2014-07-01 false Application of good engineering... of good engineering judgment to manufacturers' decisions. (a) The manufacturer shall exercise good engineering judgment in making all decisions called for under this subpart, including but not limited...

  6. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 19 2011-07-01 2011-07-01 false Application of good engineering... Application of good engineering judgment to manufacturers' decisions. (a) The manufacturer shall exercise good engineering judgment in making all decisions called for under this subpart, including but not limited...

  7. Defense programs beryllium good practice guide

    SciTech Connect

    Herr, M.

    1997-07-01

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

  8. 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...

  9. 2 CFR 176.110 - Evaluating proposals of foreign iron, steel, and/or manufactured goods.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 2 Grants and Agreements 1 2014-01-01 2014-01-01 false Evaluating proposals of foreign iron, steel... iron, steel, and/or manufactured goods. (a) If the award official receives a request for an exception based on the cost of certain domestic iron, steel, and/or manufactured goods being unreasonable,...

  10. 2 CFR 176.110 - Evaluating proposals of foreign iron, steel, and/or manufactured goods.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 2 Grants and Agreements 1 2013-01-01 2013-01-01 false Evaluating proposals of foreign iron, steel... proposals of foreign iron, steel, and/or manufactured goods. (a) If the award official receives a request for an exception based on the cost of certain domestic iron, steel, and/or manufactured goods...

  11. 2 CFR 176.110 - Evaluating proposals of foreign iron, steel, and/or manufactured goods.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 2 Grants and Agreements 1 2012-01-01 2012-01-01 false Evaluating proposals of foreign iron, steel... proposals of foreign iron, steel, and/or manufactured goods. (a) If the award official receives a request for an exception based on the cost of certain domestic iron, steel, and/or manufactured goods...

  12. 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

  13. Twenty-Two Good Educational Practices.

    ERIC Educational Resources Information Center

    Mark, Jorie Lester

    1989-01-01

    Twenty-two educational practices are drawn from nine settings: K-12, vocational and continuing education, proprietary schools, military training, corporate training, union-sponsored programs, second-chance training, job training, and adult education. They are categorized as process-type practices, techniques, and physical teaching props. (SK)

  14. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the... manufacturing practice regulations in parts 210 and 211 of this chapter and the quality system regulations...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the... manufacturing practice regulations in parts 210 and 211 of this chapter and the quality system regulations...

  16. Promoting Good Statistical Practices: Some Suggestions.

    ERIC Educational Resources Information Center

    Kirk, Roger E.

    2001-01-01

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

  17. Getting to Scale with Good Educational Practice.

    ERIC Educational Resources Information Center

    Elmore, Richard F.

    1996-01-01

    School organization and incentive structures help thwart large-scale adoption of innovative educational practices. Evidence from the progressive movement and past curriculum reform efforts suggest that wide-scale reforms are ineffective under current conditions. Change requires external normative structures, organizations that focus intrinsic…

  18. [Blood components and good practices in transfusion].

    PubMed

    Andreu, Georges

    2015-02-01

    Each year, more than three millions of blood components are transfused to more than five hundred thousand patients in France. The optimal use of blood components requires that physicians prescribing blood components master the clinical indications of red blood cells concentrates, platelet concentrates and fresh frozen plasma. In addition, physicians in charge of blood component prescription should provide adequate pre- and post-transfusion information to their patients. Compliance of blood components administration in patients with safety guidelines contributes as well to their optimal use. In addition, for each blood component transfused, a proper evaluation of its safety and its efficacy should be done. Finally, a regular evaluation of transfusion practice in hospital services were blood components are used, through audits made in cooperation with their blood component provider, either blood transfusion centre or the hospital blood bank, enables to appreciate the level of compliance with safety and clinical guidelines, and more globally how the transfusion process is mastered.

  19. [Good practice of image-guided radiotherapy].

    PubMed

    de Crevoisier, R; Créhange, G; Castelli, J; Lafond, C; Delpon, G

    2015-10-01

    Image-guided radiotherapy (IGRT) aims to take into account the anatomical variations occurring during the course of radiotherapy, by direct or indirect visualization of the target volume followed by a corrective action. The movements of the target, or at least the set-up errors are corrected by moving the treatment table, corresponding to the simplest and most validated IGRT modality in a standard practice. The deformations of the target volume and organs at risk are however much more common, and unfortunately much more complicated to consider, requiring multiple planning before or during the treatment, corresponding to the adaptive radiotherapy strategies. The planning target volume must be carefully chosen according to these anatomic variations. This article reviews the modalities of IGRT, standard or under evaluation, according to the different tumour sites.

  20. Biological nurse specialist: goodwill to good practice.

    PubMed

    Palmer, Deborah; El Miedany, Yasser

    The extensive use of biological agents in recent years for the treatment of rheumatological diseases has required a steep learning curve for the specialist nurses who manage and work in this specialty. Safe prescribing of biological therapies requires good infrastructure and specialist nursing personnel. With additional training, the specialist nurse may take responsibility for a number of tasks in the patient pathway including screening, treatment administration, patient education, prescription coordination for home drug delivery, patient support, monitoring and data collection. Biological treatment is becoming more widely used in several specialities, in particular gastroenterology, dermatology and ophthalmology. Since 2002, rheumatology specialist nurses have taken the lead in assessment and providing biologic therapy, not only for patients suffering from rheumatic diseases but also for those with immune-mediated inflammatory disorders. The unique nature and variable safety profiles of these agents led to the development of immune-mediated inflammatory disease infusion (IMID) centres and highlighted the importance of having biological specialist nurses. This article will discuss the evolution of the IMID/biologic specialist nurse role and how IMID services started with goodwill from the rheumatology nurse specialists to develop into a main component of the holistic approach to care.

  1. 2 CFR 176.110 - Evaluating proposals of foreign iron, steel, and/or manufactured goods.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 2 Grants and Agreements 1 2010-01-01 2010-01-01 false Evaluating proposals of foreign iron, steel... Evaluating proposals of foreign iron, steel, and/or manufactured goods. (a) If the award official receives a request for an exception based on the cost of certain domestic iron, steel, and/or manufactured...

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

    ERIC Educational Resources Information Center

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

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

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

    ERIC Educational Resources Information Center

    Higher Education Funding Council for Wales, Cardiff.

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

  4. 40 CFR 59.603 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... engineering judgment? 59.603 Section 59.603 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... and Applicability § 59.603 How must manufacturers apply good engineering judgment? (a) In addition to other requirements and prohibitions set forth in this subpart, you must use good engineering...

  5. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 32 2010-07-01 2010-07-01 false How must manufacturers apply good engineering judgment? 1068.5 Section 1068.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... incorrect information or overlooked important information, that you did not decide in good faith, or...

  6. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... engineering judgment? 1068.5 Section 1068.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... PROGRAMS Applicability and Miscellaneous Provisions § 1068.5 How must manufacturers apply good engineering judgment? (a) You must use good engineering judgment for decisions related to any requirements under...

  7. 40 CFR 59.603 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... engineering judgment? 59.603 Section 59.603 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... and Applicability § 59.603 How must manufacturers apply good engineering judgment? (a) In addition to other requirements and prohibitions set forth in this subpart, you must use good engineering...

  8. 40 CFR 59.603 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... engineering judgment? 59.603 Section 59.603 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... and Applicability § 59.603 How must manufacturers apply good engineering judgment? (a) In addition to other requirements and prohibitions set forth in this subpart, you must use good engineering...

  9. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... engineering judgment? 1068.5 Section 1068.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... PROGRAMS Applicability and Miscellaneous Provisions § 1068.5 How must manufacturers apply good engineering judgment? (a) You must use good engineering judgment for decisions related to any requirements under...

  10. 40 CFR 59.603 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... engineering judgment? 59.603 Section 59.603 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... and Applicability § 59.603 How must manufacturers apply good engineering judgment? (a) In addition to other requirements and prohibitions set forth in this subpart, you must use good engineering...

  11. 40 CFR 59.603 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... engineering judgment? 59.603 Section 59.603 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... and Applicability § 59.603 How must manufacturers apply good engineering judgment? (a) In addition to other requirements and prohibitions set forth in this subpart, you must use good engineering...

  12. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... engineering judgment? 1068.5 Section 1068.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... PROGRAMS Applicability and Miscellaneous Provisions § 1068.5 How must manufacturers apply good engineering judgment? (a) You must use good engineering judgment for decisions related to any requirements under...

  13. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... engineering judgment? 1068.5 Section 1068.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Miscellaneous Provisions § 1068.5 How must manufacturers apply good engineering judgment? (a) You must use good engineering judgment for decisions related to any requirements under this chapter. This includes...

  14. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... Required Use of American Iron, Steel, and Manufactured Goods (covered under International Agreements... repair of a public building or public work, and involve iron, steel, and/or manufactured goods...

  15. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... Iron, Steel, and Manufactured Goods (covered under International Agreements)—Section 1605 of the... building or public work, and involve iron, steel, and/or manufactured goods covered under...

  16. 2 CFR 176.160 - Award term-Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... Award term—Required Use of American Iron, Steel, and Manufactured Goods (covered under International... involves iron, steel, and/or manufactured goods materials covered under international agreements,...

  17. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... Required Use of American Iron, Steel, and Manufactured Goods (covered under International Agreements... repair of a public building or public work, and involve iron, steel, and/or manufactured goods...

  18. 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…

  19. 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

  20. 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.

  1. Good Security Practices for Electronic Commerce, Including Electronic Data Interchange

    DTIC Science & Technology

    1993-12-01

    FROM - TO) xx-xx-2002 to xx-xx-2002 4. TITLE AND SUBTITLE Good Security Practices for Electronic Commerce , Including Electronic Data Interchange...Report 12/1/1993 4. TITLE AND SUBTITLE Good Security Practices for Electronic Commerce , Including Electronic Data Interchange 5. FUNDING NUMBERS 6...Maximum 200 Words) Electronic commerce (EC) is the use of documents in electronic form, rather than paper, for carrying out functions of business or

  2. Guide to good practices for operations organization and administration

    SciTech Connect

    Not Available

    1992-12-01

    The purpose of this Guide to Good Practices is to provide Department of Energy (DOE) contractors with information that can be used to validate and/or modify existing programs relative to Conduct of Operations. This Guide to Good Practices is part of a series of guides designed to enhance the guidelines set forth in DOE Order 5480.19, Conduct of Operations Requirements for DOE Facilities.''

  3. Guide to good practices for operations organization and administration

    SciTech Connect

    Not Available

    1992-12-01

    The purpose of this Guide to Good Practices is to provide Department of Energy (DOE) contractors with information that can be used to validate and/or modify existing programs relative to Conduct of Operations. This Guide to Good Practices is part of a series of guides designed to enhance the guidelines set forth in DOE Order 5480.19, ``Conduct of Operations Requirements for DOE Facilities.``

  4. Good Schools for Middle Grade Youngsters: Characteristics, Practices, and Recommendations.

    ERIC Educational Resources Information Center

    Morrison, William

    Operating on the assumption that good middle schools differ significantly from other schools and that the differences should be identifiable by a disinterested observer, the author of this document visited 39 schools and attended 3 conferences to learn at first hand the characteristics of good middle schools and to identify the practices that made…

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... RADIO BROADCAST SERVICES Noncommercial Educational FM Broadcast Stations § 73.508 Standards of good... American National Standards Institute. These stations must be operated, tuned, and adjusted so that... 47 Telecommunication 4 2014-10-01 2014-10-01 false Standards of good engineering practice....

  6. Manufacturing Exploration. Practical Arts. Instructor's Manual. Competency-Based Education.

    ERIC Educational Resources Information Center

    Keeton, Martha; And Others

    This manual provides curriculum materials for implementing a career exploration class in manufacturing occupations within a Practical Arts Education program for middle/junior high school students. Introductory materials include the program master sequence, a list of manufacturing occupations, an overview of the competency-based instructional…

  7. 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...

  8. Practical Framework: Implementing OEE Method in Manufacturing Process Environment

    NASA Astrophysics Data System (ADS)

    Maideen, N. C.; Sahudin, S.; Mohd Yahya, N. H.; Norliawati, A. O.

    2016-02-01

    Manufacturing process environment requires reliable machineries in order to be able to satisfy the market demand. Ideally, a reliable machine is expected to be operated and produce a quality product at its maximum designed capability. However, due to some reason, the machine usually unable to achieved the desired performance. Since the performance will affect the productivity of the system, a measurement technique should be applied. Overall Equipment Effectiveness (OEE) is a good method to measure the performance of the machine. The reliable result produced from OEE can then be used to propose a suitable corrective action. There are a lot of published paper mentioned about the purpose and benefit of OEE that covers what and why factors. However, the how factor not yet been revealed especially the implementation of OEE in manufacturing process environment. Thus, this paper presents a practical framework to implement OEE and a case study has been discussed to explain in detail each steps proposed. The proposed framework is beneficial to the engineer especially the beginner to start measure their machine performance and later improve the performance of the machine.

  9. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under International..., maintenance, or repair of a public building or public work, and involve iron, steel, and/or manufactured...

  10. 2 CFR 176.110 - Evaluating proposals of foreign iron, steel, and/or manufactured goods.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 2 Grants and Agreements 1 2011-01-01 2011-01-01 false Evaluating proposals of foreign iron, steel... American Recovery and Reinvestment Act of 2009 § 176.110 Evaluating proposals of foreign iron, steel, and... cost of certain domestic iron, steel, and/or manufactured goods being unreasonable, in accordance...

  11. Health physics manual of good practices for tritium facilities

    SciTech Connect

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

    1991-12-01

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

  12. 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.

  13. 75 FR 73101 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds AGENCY: Food... appropriate, and other forms of information technology. Current Good Manufacturing Practice Regulations for... current good manufacturing practice (cGMP) regulations for drugs, including medicated feeds....

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

    ERIC Educational Resources Information Center

    Curtis, Pinsent

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

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

    ERIC Educational Resources Information Center

    Hughes, Maria; Kypri, Photoula

    1998-01-01

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

  16. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... introduction, transmission, or spread of communicable diseases by HCT/Ps (e.g., by ensuring that the HCT/Ps...

  17. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... introduction, transmission, or spread of communicable diseases by HCT/Ps (e.g., by ensuring that the HCT/Ps...

  18. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Good guidance practices. 10.115 Section 10.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... guidance documents do not legally bind FDA, they represent the agency's current thinking. Therefore,...

  19. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Good guidance practices. 10.115 Section 10.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... guidance documents do not legally bind FDA, they represent the agency's current thinking. Therefore,...

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

    ERIC Educational Resources Information Center

    Benett, Yves

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

  1. Investment Decision Making: A Guide to Good Practice.

    ERIC Educational Resources Information Center

    Higher Education Funding Council for England, Bristol.

    This "good practice" guide is aimed at anyone in higher education in England who is involved in making decisions on investments. It focuses on the principles to be followed, rather than the techniques of appraisal. The guide outlines the steps for developing an outline business case and then refining it into a full business case for the…

  2. Seven Principles for Good Practice in Undergraduate Education.

    ERIC Educational Resources Information Center

    Chickering, Arthur W.; Gamson, Zelda F.

    1987-01-01

    Seven principles that can help to improve undergraduate education are identified. Based on research on college teaching and learning, good practice in undergraduate education: (1) encourages contacts between students and faculty; (2) develops reciprocity and cooperation among students; (3) uses active learning techniques; (4) gives prompt…

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

    SciTech Connect

    1992-07-01

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

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

    SciTech Connect

    Not Available

    1992-07-01

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

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

    ERIC Educational Resources Information Center

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

    2015-01-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

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

    ERIC Educational Resources Information Center

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

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

  8. Corruption at the data capture stage and good laboratory practices

    SciTech Connect

    Ziegler, E.; Lenk, H.

    1994-05-01

    Possible sources of data corruption at the data capture stage include errors from the analogue input signal to be sampled, incorrect timing of the realtime sampling, loss of data on the data transmission path, and malfunctions of hardware and software components. Hardware and software measures to avoid such errors and provisions to adhere to good laboratory practice rules are discussed. 9 refs., 3 figs.

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

    ERIC Educational Resources Information Center

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

    2013-01-01

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

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

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2015

    2015-01-01

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

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

    ERIC Educational Resources Information Center

    Forum on Education Abroad, 2011

    2011-01-01

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

  12. [Changes in the norms governing practices for the manufacture of pharmaceutical products: implications for the MERCOSUR].

    PubMed

    Temprano, G; Prats, S; Bregni, C

    1998-11-01

    It is done a comparative study between the "Recommended rules for drug products manufacturing and inspection", approved in 1975 by the World Health Organization (and still in force in the MERCOSUR); and the standards published in 1992 by the WHO Expert Committee on Specifications for Pharmaceutical Preparations 32nd Report, named "Good Manufacturing Practices for pharmaceutical products". The correspondence between the regulation in force in the MERCOSUR and the Good Manufacturing Practices Inspection Guide for pharmaceutical industry, used by Health Authorities in the Common Market Member States, is analysed. It is noticed a disagreement between the rule in force and the instrument for verifying its fulfillment. The proposal of this article is the adoption by the Common Market Group, of the rules published by the WHO in 1992, and the establishment of an inspection guide which absolute agrees with it.

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

    NASA Astrophysics Data System (ADS)

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

    2015-08-01

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

  14. Health physics manual of good practices for accelerator facilities

    SciTech Connect

    Casey, W.R.; Miller, A.J.; McCaslin, J.B.; Coulson, L.V.

    1988-04-01

    It is hoped that this manual will serve both as a teaching aid as well as a useful adjunct for program development. In the context of application, this manual addresses good practices that should be observed by management, staff, and designers since the achievement of a good radiation program indeed involves a combined effort. Ultimately, radiation safety and good work practices become the personal responsibility of the individual. The practices presented in this manual are not to be construed as mandatory rather they are to be used as appropriate for the specific case in the interest of radiation safety. As experience is accrued and new data obtained in the application of this document, ONS will update the guidance to assure that at any given time the guidance reflects optimum performance consistent with current technology and practice.The intent of this guide therefore is to: define common health physics problems at accelerators; recommend suitable methods of identifying, evaluating, and managing accelerator health physics problems; set out the established safety practices at DOE accelerators that have been arrived at by consensus and, where consensus has not yet been reached, give examples of safe practices; introduce the technical literature in the accelerator health physics field; and supplement the regulatory documents listed in Appendix D. Many accelerator health physics problems are no different than those at other kinds of facilities, e.g., ALARA philosophy, instrument calibration, etc. These problems are touched on very lightly or not at all. Similarly, this document does not cover other hazards such as electrical shock, toxic materials, etc. This does not in any way imply that these problems are not serious. 160 refs.

  15. A model for reflection for good clinical practice.

    PubMed

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

    2009-12-01

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

  16. Manufacturing waste disposal practices of the chemical propulsion industry

    NASA Technical Reports Server (NTRS)

    Goldberg, Benjamin E.; Adams, Daniel E.; Schutzenhofer, Scott A.

    1995-01-01

    The waste production, mitigation and disposal practices of the United States chemical propulsion industry have been investigated, delineated, and comparatively assessed to the U.S. industrial base. Special emphasis has been placed on examination of ozone depleting chemicals (ODC's). The research examines present and anticipated future practices and problems encountered in the manufacture of solid and liquid propulsion systems. Information collected includes current environmental laws and regulations that guide the industry practices, processes in which ODC's are or have been used, quantities of waste produced, funding required to maintain environmentally compliant practices, and preventive efforts.

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

    SciTech Connect

    Not Available

    1992-07-01

    The purpose of the Department of Energy (DOE) Guide to Good Practices for On-the-Job Training (OJT) is to provide DOE contractor organizations with information that can be used to modify existing programs or to develop new programs. This guide replaces the Guide to Good Practices for On-the-Job Training that was distributed to DOE and DOE contractors in 1987. DOE contractors should not feel obligated to adopt all parts of this guide. Rather, they can use the information in this guide to develop programs that apply to their facility. This guide can be used as an aid in the design and development of a facility's OJT programs and to assist the instructors who conduct OJT and performance tests in the areas of facility operations, maintenance, and technical supports.

  18. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... American Recovery and Reinvestment Act of 2009 § 176.170 Notice of Required Use of American Iron, Steel... work, and involve iron, steel, and/or manufactured goods covered under international agreements,...

  19. 2 CFR 176.160 - Award term-Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... American Iron, Steel, and Manufactured Goods (covered under International Agreements)—Section 1605 of the..., alteration, maintenance, or repair of a public building or public work that involves iron, steel,...

  20. 2 CFR 176.160 - Award term-Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American...—Required Use of American Iron, Steel, and Manufactured Goods (covered under International Agreements... construction, alteration, maintenance, or repair of a public building or public work that involves iron,...

  1. 2 CFR 176.160 - Award term-Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American...—Required Use of American Iron, Steel, and Manufactured Goods (covered under International Agreements... construction, alteration, maintenance, or repair of a public building or public work that involves iron,...

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

    PubMed

    Gillon, Raanan

    2015-01-01

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

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

    SciTech Connect

    1998-04-01

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

  4. Guide to good practices for operations organization and administration

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Operations Organization and Administration, Chapter I of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing operations organization and administration programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. This standard should be used in conjunction with principles of the Integrated Safety Management System as incorporated in DOE G 450.4-1, Integrated Safety Management System Guide. Operations Organization and Administration is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for well-defined standards and requirements for safe and efficient operations.

  5. Good quantification practices of flavours and fragrances by mass spectrometry

    PubMed Central

    Begnaud, Frédéric

    2016-01-01

    Over the past 15 years, chromatographic techniques with mass spectrometric detection have been increasingly used to monitor the rapidly expanded list of regulated flavour and fragrance ingredients. This trend entails a need for good quantification practices suitable for complex media, especially for multi-analytes. In this article, we present experimental precautions needed to perform the analyses and ways to process the data according to the most recent approaches. This notably includes the identification of analytes during their quantification and method validation, when applied to real matrices, based on accuracy profiles. A brief survey of application studies based on such practices is given. This article is part of the themed issue ‘Quantitative mass spectrometry’. PMID:27644977

  6. Developing a policy for paediatric biobanks: principles for good practice

    PubMed Central

    Hens, Kristien; Van El, Carla E; Borry, Pascal; Cambon-Thomsen, Anne; Cornel, Martina C; Forzano, Francesca; Lucassen, Anneke; Patch, Christine; Tranebjaerg, Lisbeth; Vermeulen, Eric; Salvaterra, Elena; Tibben, Aad; Dierickx, Kris

    2013-01-01

    The participation of minors in biobank research can offer great benefits for science and health care. However, as minors are a vulnerable population they are also in need of adequate protective measures when they are enrolled in research. Research using biobanked biological samples from children poses additional ethical issues to those raised by research using adult biobanks. For example, small children have only limited capacity, if any, to understand the meaning and implications of the research and to give a documented agreement to it. Older minors are gradually acquiring this capacity. We describe principles for good practice related to the inclusion of minors in biobank research, focusing on issues related to benefits and subsidiarity, consent, proportionality and return of results. Some of these issues are currently heavily debated, and we conclude by providing principles for good practice for policy makers of biobanks, researchers and anyone involved in dealing with stored tissue samples from children. Actual implementation of the principles will vary according to different jurisdictions. PMID:22713814

  7. [Good Practice of Secondary Data Analysis (GPS): guidelines and recommendations].

    PubMed

    Swart, E; Gothe, H; Geyer, S; Jaunzeme, J; Maier, B; Grobe, T G; Ihle, P

    2015-02-01

    In 2005, the Working Group for the Survey and Utilisation of Secondary Data (AGENS) of the German Society for Social Medicine and Prevention (DGSMP) and the German Society for Epidemiology (DGEpi) first published "Good Practice in Secondary Data Analysis (GPS)" formulating a standard for conducting secondary data analyses. GPS is intended as a guide for planning and conducting analyses and can provide a basis for contracts between data owners. The domain of these guidelines does not only include data routinely gathered by statutory health insurance funds and further statutory social insurance funds, but all forms of secondary data. The 11 guidelines range from ethical principles and study planning through quality assurance measures and data preparation to data privacy, contractual conditions and responsible communication of analytical results. They are complemented by explanations and practical assistance in the form of recommendations. GPS targets all persons directing their attention to secondary data, their analysis and interpretation from a scientific point of view and by employing scientific methods. This includes data owners. Furthermore, GPS is suitable to assess scientific publications regarding their quality by authors, referees and readers. In 2008, the first version of GPS was evaluated and revised by members of AGENS and the Epidemiological Methods Working Group of DGEpi, DGSMP and GMDS including other epidemiological experts and had then been accredited as implementation regulations of Good Epidemiological Practice (GEP). Since 2012, this third version of GPS is on hand and available for downloading from the DGEpi website at no charge. Especially linguistic specifications have been integrated into the current revision; its internal consistency was increased. With regards to contents, further recommendations concerning the guideline on data privacy have been added. On the basis of future developments in science and data privacy, further revisions will

  8. 75 FR 16345 - Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 10 (formerly Docket No. 1999N-4783) Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment AGENCY: Food and...

  9. [Good Laboratory Practice (GPL) and quality control in Dutch laboratories].

    PubMed

    Goudswaard, J

    1991-03-15

    A review of the origin of GLP (Good Laboratory Practice) and ISO (International Standard Organisation) directives is followed by a number of definitions of concepts such as quality, guarantees of quality, quality systems, etc. by laboratories (NEN 2653). These requirements are discussed in the paper. Certification is one of the guarantees of quality assessment by laboratories. Certification of laboratories is carried out by STERLAB (Laboratory Accreditation Board of The Netherlands) or the CCKL (National Coordination Committee for Quality Assurance for Health Care Laboratories in The Netherlands). In addition to certification, laboratories in the Netherlands are extremely active as regards external quality control (QC). QC is carried out by the various occupational groups. The paper finally closes with a discussion of future developments regarding quality control and certification in medical and veterinary diagnostic laboratories.

  10. Good clinical practice: historical background and key aspects.

    PubMed

    Otte, Andreas; Maier-Lenz, Herbert; Dierckx, Rudi A

    2005-07-01

    Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyone involved. In this review article, key aspects of GCP and the responsibilities of investigators, monitors and sponsors are described. In addition, a comprehensive overview of the historical background on the development of GCP from the US Pure Food and Drugs Act of 1906 over the Nuremberg Code, the Kefauver-Harris Amendments and the Declaration of Helsinki until now is given. Knowledge of the historical background may help understand the developments in GCP.

  11. Good practice in health, environment and safety management in enterprise.

    PubMed

    Michalak, J

    2001-01-01

    Good practice in health, environment and safety management in enterprise (GP HESME) is a process that aims at continuous improvement in health, environment and safety performance, involving all stakeholders within and outside the enterprise. This WHO program is supported by other international organizations, and the declaration of Ministers of Health and Ministers of Environment adopted in 1999. The basic issues of the GP HESME concept are presented as well as its prerequisites, benefits and participants. The key partners in GP HESME are employers and their organizations, representatives of employees, governmental agencies, local authorities, financial and insurance institutions, occupational health services, environmental and social services, associations of professionals, research and training institutions. The HESME system is intended to function at different levels: international, national, local community, and enterprise settings. The lists of expected benefits for each group of stakeholders are discussed. Evaluation of GP HESME is based on the criteria and indicators, the most important of them are briefly presented.

  12. Good Practice Guide Waste Minimization/Pollution Prevention

    SciTech Connect

    J Dorsey

    1999-10-14

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

  13. Harmonization of good laboratory practice requirements and laboratory accreditation programs.

    PubMed

    Royal, P D

    1994-09-01

    Efforts to harmonize Good Laboratory Practice (GLP) requirements have been underway through the Organization for Economic Cooperation and Development (OECD) since 1981. In 1985, a GLP panel was established to facilitate the practical implementation of the OECD/GLP program. Through the OECD/GLP program, Memoranda of Understanding (MOU) agreements which foster requirements for reciprocal data and study acceptance and unified GLP standards have been developed among member countries. Three OECD Consensus Workshops and three inspectors training workshops have been held. In concert with these efforts, several OECD countries have developed GLP accreditation programs, managed by local health and environmental ministries. In addition, Canada and the United States are investigating Laboratory Accreditation programs for environmental monitoring assessment and GLP-regulated studies. In the European Community (EC), the need for quality standards specifying requirements for production and international trade has promoted International Standards Organization (ISO) certification for certain products. ISO-9000 standards identify requirements for certification of quality systems. These certification programs may affect the trade and market of laboratories conducting GLP studies. Two goals identified by these efforts are common to both programs: first, harmonization and recognition of requirements, and second, confidence in the rigor of program components used to assess the integrity of data produced and study activities. This confidence can be promoted, in part, through laboratory inspection and screening processes. However, the question remains, will data produced by sanctioned laboratories be mutually accepted on an international basis?(ABSTRACT TRUNCATED AT 250 WORDS)

  14. 77 FR 16158 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... labeling is printed. For example, a sheet of material that contains labeling for different strengths of a...)(22)) as labeling derived from a sheet of material on which more than one item of labeling is printed... labels for different drug products or different strengths for the same drug product are...

  15. Good clinical practice in resource-limited settings: translating theory into practice.

    PubMed

    Tinto, Halidou; Noor, Ramadhani A; Wanga, Charles L; Valea, Innocent; Mbaye, Maimouna Ndour; D'Alessandro, Umberto; Ravinetto, Raffaella M

    2013-04-01

    A Good Clinical Practices (GCPs) course, based on the combination of theoretical modules with a practical training in real-life conditions, was held in 2010 in Burkina Faso. It was attended by 15 trainees from nine African, Asian, and Latin American countries. There were some discrepancies between the average good results at the end of the theoretical phase and the GCP application during the first days of the practical phase, underlying the difficulties of translating theoretical knowledge into good practices. Most of the findings were not unexpected and reflected the challenges commonly faced by clinical investigators in resource-poor contexts (i.e., the high workload at peripheral health facilities, the need to conciliate routine clinical activities with clinical research, and the risk of creating a double standard among patients attending the same health facility [free care for recruited patients versus user fees for non-recruited patients with the same medical condition]). Even if limited in number and time, these observations suggest that a theoretical training alone may not be sufficient to prepare trainees for the challenges of medical research in real-life settings. Conversely, when a practical phase immediately follows a theoretical one, trainees can immediately experience what the research methodology implicates in terms of work organization and relationship with recruited and non-recruited patients. This initial experience shows the complexity of translating GCP into practice and suggests the need to rethink the current conception of GCP training.

  16. 2 CFR 176.140 - Award term-Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... Reinvestment Act of 2009 § 176.140 Award term—Required Use of American Iron, Steel, and Manufactured Goods..., steel, and/or manufactured goods covered under international agreements, the agency shall use the...

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

    SciTech Connect

    1997-01-01

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

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

    PubMed

    Xie, Yan-Ming; Tian, Feng

    2013-09-01

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

  19. Good Practice in Student Affairs: Principles To Foster Student Learning.

    ERIC Educational Resources Information Center

    Blimling, Gregory S.; Whitt, Elizabeth J.

    This book, based on the conclusions of a study of practices in college student affairs, presents nine papers which identify the best practices in student affairs, review research used to define the best practices, and give examples of how to use these practices in the field. The book is based on a 1996 meeting of an interdisciplinary study group…

  20. [Decree on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use].

    PubMed

    Schwerdtfeger, W K

    2005-02-01

    In Germany, Directive 2001/20/EC is implemented by articles 40 to 42a of the Federal Drug Act and by the Decree on Good Clinical Practice. Pivotal provisions have been included into the Federal Drug Act, such as those aiming at the clinical trial subject's protection and defining responsibilities for the evaluation of applications as well as for pharmacovigilance and surveillance. The Decree comprises: relevant definitions; requirements for manufacturing, importation and labelling of investigational medicinal products; the procedures to obtain the ethics committee's opinion and the authorization from the competent authority on the trial application and on amendments thereof; documentation and information tasks of the investigator, sponsor and competent authority; rules for inspection to verify compliance with good clinical and manufacturing practice. Finally, the decree lists infringements within the meaning of article 97, paragraph 2, no. 31 of the Federal Drug Act, and lays down the necessary provisions for a transitional period and the entering into force of the new provisions.

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

    PubMed

    Polenakovic, Momir; Gucev, Zoran

    2014-01-01

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

  2. Bioseparation in antibody manufacturing: the good, the bad and the ugly.

    PubMed

    Gottschalk, Uwe

    2008-01-01

    Improvements in upstream production have boosted productivity in the biomanufacturing industry, but this is leading to bottlenecks in downstream processing as current technology platforms reach their limits of throughput and scalability. Although chromatography remains an indispensible component of downstream processing due to its simplicity and high resolving power (The Good), there is virtually no economy of scale effect so more product translates almost linearly into greater production costs. Bind-and-elute processes (such as the initial capture step in antibody manufacturing) are volume-driven and therefore have knock-on effects that impact on the entire production facility since the space required for preparation, storage, and cleaning steps has to be similarly adapted (The Bad). During long-term operations with multiple cycles, thorough cleaning is necessary to prevent progressive fouling and microbial contamination (The Ugly). Innovative solutions are required, which may include revisiting simpler and less expensive separation technologies, the use of disposable modules, and the integration of improved processes that are scalable to cope with increased demands. Among the alternatives that have been put forward, membrane adsorbers are beginning to make a real impact on the industry, particularly for flow-through applications such as polishing and viral clearance.

  3. Good Cell Culture Practice for stem cells and stem-cell-derived models.

    PubMed

    Pamies, David; Bal-Price, Anna; Simeonov, Anton; Tagle, Danilo; Allen, Dave; Gerhold, David; Yin, Dezhong; Pistollato, Francesca; Inutsuka, Takashi; Sullivan, Kristie; Stacey, Glyn; Salem, Harry; Leist, Marcel; Daneshian, Mardas; Vemuri, Mohan C; McFarland, Richard; Coecke, Sandra; Fitzpatrick, Suzanne C; Lakshmipathy, Uma; Mack, Amanda; Wang, Wen Bo; Yamazaki, Daiju; Sekino, Yuko; Kanda, Yasunari; Smirnova, Lena; Hartung, Thomas

    2017-01-01

    The first guidance on Good Cell Culture Practice (GCCP) dates back to 2005. This document expands this to include aspects of quality assurance for in vitro cell culture focusing on the increasingly diverse cell types and culture formats used in research, product development, testing and manufacture of biotechnology products and cell-based medicines. It provides a set of basic principles of best practice that can be used in training new personnel, reviewing and improving local procedures, and helping to assure standard practices and conditions for the comparison of data between laboratories and experimentation performed at different times. This includes recommendations for the documentation and reporting of culture conditions. It is intended as guidance to facilitate the generation of reliable data from cell culture systems, and is not intended to conflict with local or higher level legislation or regulatory requirements. It may not be possible to meet all recommendations in this guidance for practical, legal or other reasons. However, when it is necessary to divert from the principles of GCCP, the risk of decreasing the quality of work and the safety of laboratory staff should be addressed and any conclusions or alternative approaches justified. This workshop report is considered a first step toward a revised GCCP 2.0.

  4. 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…

  5. 21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING... manufacturing record, the batch production record, and manufacturing operations? (a) Quality control...

  6. 21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING... manufacturing record, the batch production record, and manufacturing operations? (a) Quality control...

  7. 21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING... manufacturing record, the batch production record, and manufacturing operations? (a) Quality control...

  8. Addressing the challenge of diversity in the graduate ranks: good practices yield good outcomes.

    PubMed

    Thompson, Nancy L; Campbell, Andrew G

    2013-01-01

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

  9. Educating for Good Work: From Research to Practice

    ERIC Educational Resources Information Center

    Mucinskas, Daniel; Gardner, Howard

    2013-01-01

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

  10. 2 CFR 176.150 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... 2009 § 176.150 Notice of Required Use of American Iron, Steel, and Manufactured Goods—Section 1605 of... public building or public work, and do not involve iron, steel, and/or manufactured goods covered...

  11. 2 CFR 176.150 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... Reinvestment Act of 2009 § 176.150 Notice of Required Use of American Iron, Steel, and Manufactured Goods... repair of a public building or public work, and do not involve iron, steel, and/or manufactured...

  12. 2 CFR 176.140 - Award term-Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... American Iron, Steel, and Manufactured Goods—Section 1605 of the American Recovery and Reinvestment Act of... building or public work that does not involve iron, steel, and/or manufactured goods covered...

  13. 2 CFR 176.150 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... Iron, Steel, and Manufactured Goods—Section 1605 of the American Recovery and Reinvestment Act of 2009..., steel, and/or manufactured goods covered under international agreements, the agency shall use the...

  14. A pilot-scale nonwoven roll goods manufacturing process reduces microbial burden to pharmacopeia acceptance levels for nonsterile hygiene applications

    Technology Transfer Automated Retrieval System (TEKTRAN)

    A total of seven source fiber types were selected for use in the manufacturing of nonwoven roll goods: polyester; polypropylene; rayon; greige cotton from two sources; mechanically cleaned greige cotton; and scoured and bleached cotton. The microbial burden of each source fiber was measured as a pr...

  15. 2 CFR 176.160 - Award term-Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... American Recovery and Reinvestment Act of 2009 § 176.160 Award term—Required Use of American Iron, Steel..., maintenance, or repair of a public building or public work that involves iron, steel, and/or...

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

    ERIC Educational Resources Information Center

    Callan, Patrick M.; Ewell, Peter T.; Finney, Joni E.; Jones, Dennis P.

    2007-01-01

    This report describes a wide range of successful strategies that states can draw from to increase the educational attainment of their residents while holding down higher education costs. Part I offers examples of strategies, programs, and practices that the authors' research finds can raise educational productivity. Part II describes the levers…

  17. Collaborative Practice: The Basis of Good Educational Work

    ERIC Educational Resources Information Center

    James, Chris

    2007-01-01

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

  18. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Noncommercial Educational FM Broadcast Stations § 73.508 Standards of good... watts transmitter power output shall be subject to all of the provisions of the FM Technical...

  19. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Noncommercial Educational FM Broadcast Stations § 73.508 Standards of good... watts transmitter power output shall be subject to all of the provisions of the FM Technical...

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

    PubMed Central

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

    2016-01-01

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

  1. Developing Countries Vaccine Manufacturers Network: doing good by making high-quality vaccines affordable for all.

    PubMed

    Pagliusi, Sonia; Leite, Luciana C C; Datla, Mahima; Makhoana, Morena; Gao, Yongzhong; Suhardono, Mahendra; Jadhav, Suresh; Harshavardhan, Gutla V J A; Homma, Akira

    2013-04-18

    The Developing Countries Vaccine Manufacturers Network (DCVMN) is a unique model of a public and private international alliance. It assembles governmental and private organizations to work toward a common goal of manufacturing and supplying high-quality vaccines at affordable prices to protect people around the world from known and emerging infectious diseases. Together, this group of manufacturers has decades of experience in manufacturing vaccines, with technologies, know-how, and capacity to produce more than 40 vaccines types. These manufacturers have already contributed more than 30 vaccines in various presentations that have been prequalified by the World Health Organization for use by global immunization programmes. Furthermore, more than 45 vaccines are in the pipeline. Recent areas of focus include vaccines to protect against rotavirus, human papillomavirus (HPV), Japanese encephalitis, meningitis, hepatitis E, poliovirus, influenza, and pertussis, as well as combined pentavalent vaccines for children. The network has a growing number of manufacturers that produce a growing number of products to supply the growing demand for vaccines in developing countries.

  2. Considering the Physical Environment: An Essential Component of Good Practice.

    ERIC Educational Resources Information Center

    Gutheil, Irene A.

    1992-01-01

    Discusses physical environment and its effect on behavior. Reviews theories about impact of space organization and concepts useful to understanding people's relationships with their environments. Focuses on application of theory about people's physical settings to social work practice. Presents case examples, reviews skills for translating…

  3. Understanding and Developing Good Practice: Language Teaching in Higher Education

    ERIC Educational Resources Information Center

    Klapper, John

    2006-01-01

    This new book supports the professional development and training of Modern Languages teachers in higher education. It links insights from pedagogical and applied linguistic research to the practicalities of the undergraduate language syllabus. The aim is to interpret research for the classroom practitioner so that teaching can be based on sound…

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

    ERIC Educational Resources Information Center

    Lilley, Kathleen; Barker, Michelle; Harris, Neil

    2015-01-01

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

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

    PubMed

    Hills, Laura

    2013-01-01

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

  6. Validation of analytical methods in compliance with good manufacturing practice: a practical approach

    PubMed Central

    2013-01-01

    Background The quality and safety of cell therapy products must be maintained throughout their production and quality control cycle, ensuring their final use in the patient. We validated the Lymulus Amebocyte Lysate (LAL) test and immunophenotype according to International Conference on Harmonization Q2 Guidelines and the EU Pharmacopoeia, considering accuracy, precision, repeatability, linearity and range. Methods For the endotoxin test we used a kinetic chromogenic LAL test. As this is a limit test for the control of impurities, in compliance with International Conference on Harmonization Q2 Guidelines and the EU Pharmacopoeia, we evaluated the specificity and detection limit. For the immunophenotype test, an identity test, we evaluated specificity through the Fluorescence Minus One method and we repeated all experiments thrice to verify precision. The immunophenotype validation required a performance qualification of the flow cytometer using two types of standard beads which have to be used daily to check cytometer reproducibly set up. The results were compared together. Collected data were statistically analyzed calculating mean, standard deviation and coefficient of variation percentage (CV%). Results The LAL test is repeatable and specific. The spike recovery value of each sample was between 0.25 EU/ml and 1 EU/ml with a CV% < 10%. The correlation coefficient (≥ 0.980) and CV% (< 10%) of the standard curve tested in duplicate showed the test's linearity and a minimum detectable concentration value of 0.005 EU/ml. The immunophenotype method performed thrice on our cell therapy products is specific and repeatable as showed by CV% inter -experiment < 10%. Conclusions Our data demonstrated that validated analytical procedures are suitable as quality controls for the batch release of cell therapy products. Our paper could offer an important contribution for the scientific community in the field of CTPs, above all to small Cell Factories such as ours, where it is not always possible to have CFR21 compliant software. PMID:23981284

  7. Setting good practices to assess the efficiency of iron fertilizers.

    PubMed

    El-Jendoubi, Hamdi; Melgar, Juan Carlos; Alvarez-Fernández, Ana; Sanz, Manuel; Abadía, Anunciación; Abadía, Javier

    2011-05-01

    The most prevalent nutritional disorder in fruit tree crops growing in calcareous soils is Fe deficiency chlorosis. Iron-deficient, chlorotic tree orchards require Fe-fertilization, since chlorosis causes decreases in tree vegetative growth as well as fruit yield and quality losses. When assessing the effectiveness of Fe-fertilizers, it is necessary to use sound practices based in the state-of-the art knowledge on the physiology and biochemistry of Fe deficiency. This review provides an overview on how to carry out the assessment of the efficiency of Fe-fertilizers, discussing common errors found in the literature, outlining adequate procedures and giving real examples of practical studies carried out in our laboratory in the past decade. The review focuses on: i) the design of Fe-fertilization experiments, discussing several issues such as the convenience of using controlled conditions or field experiments, whether fertilizer assessment experiments should mimic usual fertilization practices, as well as aspects regarding product formulations, dosages, control references and number of replicates; ii) the assessment of chlorosis recovery upon Fe-fertilization by monitoring leaf chlorophyll, and iii) the analysis of the plant responses upon Fe-fertilization, discussing the phases of leaf chlorosis recovery and the control of other leaf nutritional parameters.

  8. A compilation of Good Laboratory Practice questions and (where to get the) answers.

    PubMed

    Mayer, D E; Purdue, T W

    1995-12-01

    Since the inception of the Food and Drug Administration's Good Laboratory Practice Regulations and Environmental Protection Agency's Good Laboratory Practice Standards, many "questions and answer" documents have been produced. Our purpose in this presentation is to pull together some of these reference documents and provide a cross-reference index to sort through the many topics and questions. The combined reference resource and index provide the quality assurance professional a useful Good Laboratory Practice information tool.

  9. Good practice for conducting and reporting MEG research

    PubMed Central

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

    2013-01-01

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

  10. 48 CFR 52.225-22 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Statute...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Statute-Construction Materials. 52.225-22 Section... of Required Use of American Iron, Steel, and Manufactured Goods—Buy American Statute—Construction... Iron, Steel, and Manufactured Goods—Buy American Statute—Construction Materials (MAY 2014)...

  11. 48 CFR 52.225-24 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials Under Trade Agreements....225-24 Notice of Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act...: Notice of Required Use of American Iron, Steel, and Manufactured Goods—Buy American...

  12. 48 CFR 52.225-23 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials Under Trade Agreements. 52....225-23 Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction... American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials Under Trade...

  13. 48 CFR 52.225-23 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials Under Trade Agreements. 52....225-23 Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction... American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials Under Trade...

  14. 48 CFR 52.225-23 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Statute-Construction...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Statute-Construction Materials Under Trade Agreements....225-23 Required Use of American Iron, Steel, and Manufactured Goods—Buy American Statute—Construction... American Iron, Steel, and Manufactured Goods—Buy American Statute—Construction Materials Under...

  15. 48 CFR 52.225-24 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Statute...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Statute-Construction Materials Under Trade....225-24 Notice of Required Use of American Iron, Steel, and Manufactured Goods—Buy American Statute...: Notice of Required Use of American Iron, Steel, and Manufactured Goods—Buy American...

  16. 48 CFR 52.225-24 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials Under Trade Agreements....225-24 Notice of Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act...: Notice of Required Use of American Iron, Steel, and Manufactured Goods—Buy American...

  17. 48 CFR 52.225-23 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials Under Trade Agreements. 52....225-23 Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction... American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials Under Trade...

  18. 48 CFR 52.225-24 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials Under Trade Agreements....225-24 Notice of Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act...: Notice of Required Use of American Iron, Steel, and Manufactured Goods—Buy American...

  19. 48 CFR 52.225-24 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials Under Trade Agreements....225-24 Notice of Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act...: Notice of Required Use of American Iron, Steel, and Manufactured Goods—Buy American...

  20. 48 CFR 52.225-23 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials Under Trade Agreements. 52....225-23 Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction... American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials Under Trade...

  1. Enteral tube feeding: using good practice to prevent infection.

    PubMed

    Malhi, Hardip

    2017-01-12

    Enteral tube feeding is the delivery of nutritionally complete feed via a tube into the gut. It is used for patients who are unable to meet their nutritional needs orally. Enteral feeding can be given through a variety of different tubes that access the gastrointestinal tract either via the stomach or the small bowel. The contamination of enteral feed can often be overlooked as a source of bacterial infection. Enteral feeds can become contaminated in a variety of different ways. Most often infections result in extended lengths of stay in hospital and patients also need additional therapies and treatments in order to resolve these infections. Healthcare-associated infections not only affect the patients who acquire them but also have an impact on the staff involved in their care. Each acute trust will have its own local policies and guidelines regarding enteral feeding and infection control and prevention. These local documents will be based on national initiatives and guidelines. It is important for nurses to refer to their local policies and guidelines before they start a patient on enteral feeding to ensure that they are doing so in the safest manner possible. Nurses' practice is key to preventing bacterial contamination in such patients.

  2. Exposure to rubber fume and rubber process dust in the general rubber goods, tyre manufacturing and retread industries.

    PubMed

    Dost, A A; Redman, D; Cox, G

    2000-08-01

    This study assesses the current patterns and levels of exposure to rubber fume and rubber process dust in the British rubber industry and compares and contrasts the data obtained from the general rubber goods (GRG), retread tire (RT) and new tire (NT) sectors. A total of 179 rubber companies were visited and data were obtained from 52 general rubber goods, 29 retread tire and 7 new tire manufacturers. The survey was conducted using a questionnaire and included a walk-through inspection of the workplace to assess the extent of use of control measures and the nature of work practices being employed. The most recent (predominantly 1995-97) exposure monitoring data for rubber fume and rubber process dust were obtained from these companies; no additional sampling was conducted for the purpose of this study. In addition to the assessment of exposure data, evaluation of occupational hygiene reports for the quality of information and advice was also carried out.A comparison of the median exposures for processes showed that the order of exposure to rubber fume (E, in mg m(-3)) is: E(moulding) (0.40) approximately E(extrusion) (0.33)>E(milling) (0.18) for GRG; E(press) (0. 32)>E(extrusion) (0.19)>E(autoclave) (0.10) for RT; and E(press) (0. 22) approximately E(all other) (0.22) for NT. The order of exposure to rubber fume between sectors was E(GRG) (0.40)>E(RT) (0.32)>E(NT) (0.22). Median exposures to rubber process dust in the GRG was E(weighing) (4.2)>E(mixing) (1.2) approximately E(milling) (0.8) approximately E(extrusion) (0.8) and no significant difference (P=0. 31) between GRG and NT sectors. The findings compare well with the study carried out in the Netherlands [Kromhout et al. (1994), Annals of Occupational Hygiene 38(1), 3-22], and it is suggested that the factors governing the significant differences noted between the three sectors relate principally to the production and task functions and also to the extent of controls employed. Evaluation of occupational

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

    PubMed Central

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

    2016-01-01

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

  4. 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…

  5. 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.…

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

    PubMed

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

    2012-01-01

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

  7. 2 CFR 176.140 - Award term-Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... and Reinvestment Act of 2009 § 176.140 Award term—Required Use of American Iron, Steel, and... that does not involve iron, steel, and/or manufactured goods covered under international...

  8. 2 CFR 176.140 - Award term-Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... and Reinvestment Act of 2009 § 176.140 Award term—Required Use of American Iron, Steel, and... that does not involve iron, steel, and/or manufactured goods covered under international...

  9. Reducing DfM to practice: the lithography manufacturability assessor

    NASA Astrophysics Data System (ADS)

    Liebmann, Lars; Mansfield, Scott; Han, Geng; Culp, James; Hibbeler, Jason; Tsai, Roger

    2006-03-01

    The need for accurate quantification of all aspects of design for manufacturability using a mutually compatible set of quality-metrics and units-of-measure, is reiterated and experimentally verified. A methodology to quantify the lithography component of manufacturability is proposed and its feasibility demonstrated. Three stages of lithography manufacturability assessment are described: process window analysis on realistic integrated circuits following layout manipulations for resolution enhancement and the application of optical proximity correction, failure sensitivity analysis on simulated achievable dimensional bounds (a.k.a. variability bands), and yield risk analysis on iso-probability bands. The importance and feasibility of this technique is demonstrated by quantifying the lithography manufacturability impact of redundant contact insertion and Critical Area optimization in units that can be used to drive an overall layout optimization. The need for extensive experimental calibration and improved simulation accuracy is also highlighted.

  10. [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.

  11. Modeling study of air pollution due to the manufacture of export goods in China's Pearl River Delta

    SciTech Connect

    David G. Streets; Carolyne Yu; Michael H. Bergin; Xuemei Wang; Gregory R. Carmichael

    2006-04-01

    The Pearl River Delta is a major manufacturing region on the south coast of China that produces more than $100 billion of goods annually for export to North America, Europe, and other parts of Asia. Considerable air pollution is caused by the manufacturing industries themselves and by the power plants, trucks, and ships that support them. It is estimated that 10-40% of emissions of primary SO{sub 2}, NOx, RSP, and VOC in the region are caused by export-related activities. Using the STEM-2K1 atmospheric transport model, it is estimated that these emissions contribute 5-30% of the ambient concentrations of SO{sub 2}, NOx, NOz, and VOC in the region. (NO{sub Z}=PAN, HONO, HNO{sub 3}, N{sub 2}O{sub 5} and organic nitrates). One reason that the exported goods are cheap and therefore attractive to consumers in developed countries is that emission controls are lacking or of low performance. It is estimated that state-of-the-art controls could be installed at an annualized cost of $0.3-3 billion, representing 0.3-3% of the value of the goods produced. Mitigation measures could be adopted without seriously affecting the prices of exported goods and would achieve considerable human health and other benefits in the form of reduced air pollutant concentrations in densely populated urban areas. 22 refs., 5 figs., 5 tabs.

  12. Good ergonomics and team diversity reduce absenteeism and errors in car manufacturing.

    PubMed

    Fritzsche, Lars; Wegge, Jürgen; Schmauder, Martin; Kliegel, Matthias; Schmidt, Klaus-Helmut

    2014-01-01

    Prior research suggests that ergonomics work design and mixed teams (in age and gender) may compensate declines in certain abilities of ageing employees. This study investigates simultaneous effects of both team level factors on absenteeism and performance (error rates) over one year in a sample of 56 car assembly teams (N = 623). Results show that age was related to prolonged absenteeism and more mistakes in work planning, but not to overall performance. In comparison, high-physical workload was strongly associated with longer absenteeism and increased error rates. Furthermore, controlling for physical workload, age diversity was related to shorter absenteeism, and the presence of females in the team was associated with shorter absenteeism and better performance. In summary, this study suggests that both ergonomics work design and mixed team composition may compensate age-related productivity risks in manufacturing by maintaining the work ability of older employees and improving job quality.

  13. [Documentation of good distribution practice of medicines and its implementation in Lithuanian drug distribution companies].

    PubMed

    Draksiene, Gailute; Petkevicius, Henrikas; Radziūnas, Raimondas

    2003-01-01

    Good Distribution Practice of medicinal products for human use is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs, intended human consumption. A drug is a specific product and its mishandling is dangerous to human health and life. Therefore it is necessary to strictly control the movement of the drug from the producer to the consumer so that poor quality drugs do not have access to the market. Good Distribution Practice rules set the general requirements for good wholesale distribution practice of drugs, intended for human consumption. In order for company to meet the specified requirements, the drug distribution company must have all suitable and necessary premises, machinery, equipment, the required number of employees and specified documentation. The preparation of the Good Distribution Practice documentation is one of the most important and complex aspects when implementing the Good Distribution Practice in the companies. The article deals with the analysis of results obtained during the research of drug distribution companies in Lithuania. The research revealed that drug distribution companies put emphasis on the equipment of storage premises. Less attention is being paid to the preparation of the documents of Good Distribution Practice. The article thus presents the analysis of Good Distribution Practice documents prepared by the drug distribution companies.

  14. The practical aspects of quality assurance in Good Laboratory Practice studies in an emergency situation.

    PubMed

    Nomura, A; Takahashi, T

    1995-12-01

    In this report, the damage and countermeasures taken in relation to the Great Hanshin Earthquake are described. We report on the measures taken to counter damage in affected Good Laboratory Practice (GLP) studies by citing concrete examples. Case A: the testing facility was not affected, but a regulatory inspection had been scheduled for this day. Fortunately, official inspectors had reached the facility on schedule. Case B: The building for toxicology experiments was destroyed. Fortunately, most of the GLP-compliant experiments had been completed except one, the preparation of histological samples that was the last stage of the experiment. We asked the regulatory authority for appropriate countermeasures. The answer was that an inspection of the study could be conducted if an inspection is judged to be necessary. Case C: A necropsy was scheduled on this day. The study director decided that the necropsy should be postponed at least 1 week until he could secure the number of researchers needed to conduct the necropsy. Case D: The facility in Itami was destroyed. The facility was closed and the animals were moved to Kobe. The animal facility in Kobe was not affected, but because water supply stopped for 3 days, stocked water was used. Case E: Damage to computer systems in Kinki area was reported. Numerous computers fell from desks or were damaged from the impact shock. With the exception of a few, most of the damaged computers were repaired.

  15. Best Practices in School-to-Careers: The Manufacturing Industry.

    ERIC Educational Resources Information Center

    Manufacturing Industries Careers Alliance, Washington, DC.

    This booklet, which is part of a series demonstrating the scope of employer involvement in school-to-careers, highlights the efforts of six manufacturing employers and three "intermediary" organizations connecting workplace experiences to classroom learning for secondary education students. The introduction presents a series overview and…

  16. Licorice Production and Manufacturing: All-Sorts of Practical Applications for Statistics

    ERIC Educational Resources Information Center

    Watson, Jane; Skalicky, Jane; Fitzallen, Noleine; Wright, Suzie

    2009-01-01

    Among the practical applications of statistics is the collection of data from manufacturing processes. Often collected in the form of a time series, data collected from a series of measurements show the variation in those measurements, such as mass of a product manufactured. Limits are set for quality control and if these are exceeded then a…

  17. 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.

  18. 77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... drugs, devices, and biologics; as well as inspections of clinical investigators, IRBs, and research... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS....

  19. 77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Baltimore District Office,...

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

    PubMed

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

    2013-03-01

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

  1. Through the Lens of a Good Practice Framework. Looking at Our Workplace Education Programs.

    ERIC Educational Resources Information Center

    Taylor, Maurice

    A research study used trend analysis to examine case studies of 18 workplace literacy programs with a framework of good practice principles as a template to identify trends in practice. Each case study was examined using the nine components identified in the framework: program orientation, program evaluation, partnerships and participation,…

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

    ERIC Educational Resources Information Center

    Schweder, Richard A; And Others

    1995-01-01

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

  3. Institutional Inventory: Principles for Good Practice in Undergraduate Education, Fall 1990.

    ERIC Educational Resources Information Center

    Linksz, Donna

    In 1990, a survey of full-time faculty and staff was conducted at Catonsville Community College (CCC) in Maryland to assess perceptions of the college's climate, academic practices, curriculum, faculty, academic and student support services, and facilities. The "Seven Principles for Good Practices in Undergraduate Teaching" instrument was…

  4. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 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...

  5. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 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...

  6. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 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...

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

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2010

    2010-01-01

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

  8. 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 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...

  10. 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,…

  11. 48 CFR 52.225-22 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-22 Section 52... Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following provision: Notice of Required Use of American Iron, Steel,...

  12. 48 CFR 52.225-21 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-21 Section 52.225... of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following clause: Required Use of American Iron, Steel, and...

  13. 2 CFR 176.140 - Award term-Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... 2009 § 176.140 Award term—Required Use of American Iron, Steel, and Manufactured Goods—Section 1605 of..., alteration, maintenance, or repair of a public building or public work that does not involve iron, steel,...

  14. 48 CFR 52.225-21 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-21 Section 52.225... of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following clause: Required Use of American Iron, Steel, and...

  15. 48 CFR 52.225-22 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-22 Section 52... Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following provision: Notice of Required Use of American Iron, Steel,...

  16. 48 CFR 52.225-21 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Statute-Construction...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Statute-Construction Materials. 52.225-21 Section 52... of American Iron, Steel, and Manufactured Goods—Buy American Statute—Construction Materials. As prescribed in 25.1102(e), insert the following clause: Required Use of American Iron, Steel, and...

  17. 48 CFR 52.225-22 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-22 Section 52... Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following provision: Notice of Required Use of American Iron, Steel,...

  18. 48 CFR 52.225-21 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-21 Section 52.225... of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following clause: Required Use of American Iron, Steel, and...

  19. 48 CFR 52.225-21 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-21 Section 52.225... of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following clause: Required Use of American Iron, Steel, and...

  20. 48 CFR 52.225-22 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-22 Section 52... Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following provision: Notice of Required Use of American Iron, Steel,...

  1. 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.

  2. Serum eye drop preparation in Australia: Current manufacturing practice.

    PubMed

    Marks, Denese C; Fisher, Jenny; Mondy, Phillip; Segatchian, Jerard; Dennington, Peta M

    2015-08-01

    Serum eye drops are used to treat diseases such as dry eye syndrome (keratoconjunctivitis sicca), a disease of the surface of the eye that results in an unstable tear film. Patients are referred to the Australian Red Cross Blood Service by ophthalmologists for autologous serum eye drops when other therapies such as artificial tears or topical immunosuppressive agents have failed. In order to manufacture autologous serum eye drops, whole blood is collected from the patients using standard blood collection procedures. The blood is then allowed to clot to produce serum and processed into 20% serum eye drops, which are then returned to the patient for their own use. The eye drops are packaged into a long length of tubing, which is then heat-sealed to produce single-use segments. The demand for serum eye drops in Australia is increasing every year, with a 30% increase in the past 12 months.

  3. Development of FeSiBNbCu Nanocrystalline Soft Magnetic Alloys with High B s and Good Manufacturability

    NASA Astrophysics Data System (ADS)

    Wan, Fangpei; He, Aina; Zhang, Jianhua; Song, Jiancheng; Wang, Anding; Chang, Chuntao; Wang, Xinmin

    2016-10-01

    In order to develop Fe-based nanocrystalline soft magnetic alloys with high saturation magnetic flux density ( B s) and good manufacturability, the effect of the Nb content on the thermal stability, microstructural evolution and soft magnetic properties of Fe78- x Si13B8Nb x Cu1 ( x = 0, 1, 2 and 3) alloys were investigated. It is found that proper Nb addition is effective in widening the optimum annealing temperature range and refining the α-Fe grain in addition to enhancing the soft magnetic properties. For the representative Fe76 Si13B8Nb2Cu1 alloy, the effective annealing time can be over 60 min in the optimal temperature range of 500-600°C. FeSiBNbCu nanocrystalline soft magnetic alloys with desirable soft magnetic properties including high B s of 1.39 T, low coercivity ( H c) of 1.5 A/m and high effective permeability ( μ e) of 21,500 at 1 kHz have been developed. The enhanced soft magnetic performance and manufacturability of the FeSiBNbCu nanocrystalline alloys are attributed to the high activated energy for the precipitation of α-Fe(Si) and the second phase. These alloys with excellent performance have promising applications in electromagnetic fields like inductors.

  4. 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.

  5. Case studies of pre-engineered and manufactured sound isolation rooms for music practice and radio broadcast

    NASA Astrophysics Data System (ADS)

    Probst, Ron N.; Rypka, Dann

    2005-09-01

    Pre-engineered and manufactured sound isolation rooms were developed to ensure guaranteed sound isolation while offering the unique ability to be disassembled and relocated without loss of acoustic performance. Case studies of pre-engineered sound isolation rooms used for music practice and various radio broadcast purposes are highlighted. Three prominent universities wrestle with the challenges of growth and expansion while responding to the specialized acoustic requirements of these spaces. Reduced state funding for universities requires close examination of all options while ensuring sound isolation requirements are achieved. Changing curriculum, renovation, and new construction make pre-engineered and manufactured rooms with guaranteed acoustical performance good investments now and for the future. An added benefit is the optional integration of active acoustics to provide simulations of other spaces or venues along with the benefit of sound isolation.

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

    PubMed Central

    Overgaard, RV; Ingwersen, SH; Tornøe, CW

    2015-01-01

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

  7. Simulation Design for Off-Line Training of Practical Lean Manufacturing Concepts for Visual Inspection

    ERIC Educational Resources Information Center

    Tetteh, Edem; McWilliams, Douglas

    2010-01-01

    Customer needs for high-quality goods and the risk of product-liability litigation against businesses have made companies look for a way to sustain quality assurance in their products and services. Lean manufacturing is the latest and most successful system being used by companies to turn their business around. Visual inspection plays an important…

  8. Empowerment and Voice: Standards of Good Practice in the Employment of Professional Staff in Higher Education

    ERIC Educational Resources Information Center

    American Federation of Teachers, 2006

    2006-01-01

    This document sets forth standards of good practice for the employment of professional staff. These guidelines serve as a blueprint for the appropriate treatment of professional staff based on the principle that recognition and equity must be coupled with job security and professional treatment. This publication is divided into two sections: (1)…

  9. 77 FR 36277 - Academic Development of a Training Program for Good Laboratory Practices in High Containment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-18

    ... HUMAN SERVICES Food and Drug Administration Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24) AGENCY: Food and Drug Administration, HHS. ACTION... the support of a Funding Opportunity Announcement (FOA) entitled ``Academic Development of a...

  10. Good Practices in Roma Education in Bulgaria during the Years of Transition

    ERIC Educational Resources Information Center

    Kyuchukov, Hristo

    2007-01-01

    The aim of this paper is to present good educational practices from Bulgaria that relate to Roma education. In the so-called Years of Transition, educational conditions changed considerably. Non-governmental organizations have attempted to promote high-quality education for Roma children. The Bulgarian Ministry of Education has made various…

  11. Liberal Arts Colleges and Good Practices in Undergraduate Education: Additional Evidence

    ERIC Educational Resources Information Center

    Seifert, Tricia A.; Pascarella, Ernest T.; Goodman, Kathleen M.; Salisbury, Mark H.; Blaich, Charles F.

    2010-01-01

    Liberal arts colleges have prided themselves on providing students with a quality undergraduate education among a scholarly community who are interested in their holistic development. Past research has found students who attended liberal arts colleges more frequently experienced Chickering and Gamson's (1987, 1991) good practices in undergraduate…

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

    ERIC Educational Resources Information Center

    Lamont, Alexandra; Daubney, Alison; Spruce, Gary

    2012-01-01

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

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

    PubMed

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

    2016-03-01

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

  14. Institutional Selectivity and Good Practices in Undergraduate Education: How Strong Is the Link?

    ERIC Educational Resources Information Center

    Pascarella, Ernest T.; Cruce, Ty; Umbach, Paul D.; Wolniak, Gregory C.; Kuh, George D.; Carini, Robert M.; Hayek, John C.; Gonyea, Robert M.; Zhao, Chun-Mei

    2006-01-01

    Academic selectivity plays a dominant role in the public's understanding of what constitutes institutional excellence or quality in undergraduate education. In this study, we analyzed two independent data sets to estimate the net effect of three measures of college selectivity on dimensions of documented good practices in undergraduate education.…

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

    ERIC Educational Resources Information Center

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

    2012-01-01

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

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

    ERIC Educational Resources Information Center

    Bradshaw, Delia

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

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

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

    ERIC Educational Resources Information Center

    Blackmur, Douglas

    2008-01-01

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

  19. 78 FR 53151 - The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-28

    ... HUMAN SERVICES Food and Drug Administration The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

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

    ERIC Educational Resources Information Center

    Simpson, Lyn; Daws, Leonie; Wood, Leanne

    2002-01-01

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

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

    ERIC Educational Resources Information Center

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

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

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

    ERIC Educational Resources Information Center

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

    2011-01-01

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

  3. Benefits of Good Laboratory Practice as a tool to improve testing.

    PubMed

    Turnheim, D

    1993-11-01

    The Organization for Economic Cooperation and Development (OECD) has promoted Good Laboratory Practice (GLP) since the mid 1970s. This paper describes the development of the concept through international harmonisation, Quality Assurance (QA), and compliance monitoring. Ultimately this process permits Mutual Acceptance of Data (MAD). An important aspect of the OECD's programme is the promotion of related training and information exchange.

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

    ERIC Educational Resources Information Center

    Smith, Peter; Dalton, Jennifer; Henry, John

    2005-01-01

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

  5. The impact of preventive maintenance practices on manufacturing performance: A proposed model for SMEs in Malaysia

    NASA Astrophysics Data System (ADS)

    Lazim, Halim Mad; Taib, Che Azlan; Lamsali, Hendrik; Saleh, Mohamed Najib; Subramaniam, Chandrakantan

    2016-08-01

    Preventive maintenance (PM) plays important role to avoid or mitigate potential stoppages and disruptions of equipment or machinery from occurring in daily operations. PM emphasized total employee involvement and it is important for companies as well as Small and Medium Sized Enterprises (SMEs). SME sectors contribution to the Malaysian economy makes up 95% of the total manufacturers, however PM remain relatively lacking. The ability, reliability and effective maintenance management is highly important in order to achieve desired manufacturing performance. Therefore, organizational capability in planning, controlling, implementing and monitoring PM activities is important. Furthermore, empirical evidence on the potential impact of PM practices towards manufacturing performance with organizational capability as a moderating effect is still limited and indecisive. Henceforth, this paper aims to explore and investigate potential relationships between PM practices and manufacturing performance moderated by organizational capability in the contact of Malaysian SMEs in the manufacturing sector. Correspondently, the study intends to propose a new research framework and hypotheses to examine the abovementioned relationships. The proposed framework includes PM team, PM strategy and planned maintenance as the determinants, while organizational capability serves as the moderating variable. Manufacturing performance will be viewed in terms of innovation and financial factors. Proposed research direction and conclusion are discussed at the end of the study.

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

    SciTech Connect

    1998-06-01

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

  7. Project-Based Manufacturing Engineering Practice at Ibaraki University and Its Outcomes

    NASA Astrophysics Data System (ADS)

    Yamasaki, Kazuhiko; Wang, Dong F.; Maekawa, Katsuhiro

    The real world experience of manufacturing processes from an idea stage to a final product must be related to classroom lectures in mechanical engineering curriculum, including design, materials engineering, dynamics and control. Various challenges and difficulties encountered during the manufacturing engineering practice also let students recognize their creativity as well as what kinds of knowledge is missing. Awareness is the start of growth. In line with this principle we have carried out the mechanical engineering practice for 10 years. Some modifications toward “project-based practice” , however, have been made through manufacturing engineers’ real activities. Drawing and specification, process control, cost management, and role-sharing arrangement are stressed during the semester course. The present paper describes how it works and what is left to improve further, such as a refinement of themes and a coaching method for bringing out the hidden talent in students.

  8. 78 FR 16824 - Tobacco Product Manufacturing Practice; Establishment of a Public Docket

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-19

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I Tobacco Product Manufacturing Practice; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. ACTION: Establishment of a public docket; request for comments. SUMMARY: The Food and Drug Administration (FDA) is establishing a...

  9. Using Performance Analysis for Training in an Organization Implementing ISO-9000 Manufacturing Practices: A Case Study.

    ERIC Educational Resources Information Center

    Kunneman, Dale E.; Sleezer, Catherine M.

    2000-01-01

    This case study examines the application of the Performance Analysis for Training (PAT) Model in an organization that was implementing ISO-9000 (International Standards Organization) processes for manufacturing practices. Discusses the interaction of organization characteristics, decision maker characteristics, and analyst characteristics to…

  10. Importance of good manufacturing practices in microbiological monitoring in processing human tissues for transplant.

    PubMed

    Pianigiani, Elisa; Ierardi, Francesca; Fimiani, Michele

    2013-12-01

    Skin allografts represent an important therapeutic resource in the treatment of severe skin loss. The risk associated with application of processed tissues in humans is very low, however, human material always carries the risk of disease transmission. To minimise the risk of contamination of grafts, processing is carried out in clean rooms where air quality is monitored. Procedures and quality control tests are performed to standardise the production process and to guarantee the final product for human use. Since we only validate and distribute aseptic tissues, we conducted a study to determine what type of quality controls for skin processing are the most suitable for detecting processing errors and intercurrent contamination, and for faithfully mapping the process without unduly increasing production costs. Two different methods for quality control were statistically compared using the Fisher exact test. On the basis of the current study we selected our quality control procedure based on pre- and post-processing tissue controls, operator and environmental controls. Evaluation of the predictability of our control methods showed that tissue control was the most reliable method of revealing microbial contamination of grafts. We obtained 100 % sensitivity by doubling tissue controls, while maintaining high specificity (77 %).

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

    PubMed

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

    2013-06-01

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

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

    PubMed

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

    2015-09-15

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

  13. Evaluation of Practicing sustainable Industrial Solid Waste Minimization by Manufacturing Firms in Malaysia: Strengths and Weaknesses.

    PubMed

    Mallak, Shadi Kafi; Bakri Ishak, Mohd; Mohamed, Ahmad Fariz

    2016-09-13

    Malaysia is facing an increasing trend in industrial solid waste generation due to industrial development.Thus there is a paramount need in taking a serious action to move toward sustainable industrial waste management. The main aim of this study is to assess practicing solid waste minimization by manufacturing firms in Shah Alam industrial state, Malaysia. This paper presents a series of descriptive and inferential statistical analysis regarding the level and effects of practicing waste minimization methods, and seriousness of barriers preventing industries from practicing waste minimization methods. For this purpose the survey questions were designed such that both quantitative (questionnaire) and qualitative (semi-structures interview) data were collected concurrently. Analysis showed that, the majority of firms (92%) dispose their wastes rather than practice other sustainable waste management options. Also waste minimization methods such as segregation of wastes, on-site recycle and reuse, improve housekeeping and equipment modification were found to have significant contribution in waste reduction (p<0.05). Lack of expertise (M=3.50), lack of enough information (M= 3.54), lack of equipment modification (M= 3.16) and lack of specific waste minimization guidelines (M=3.49) have higher mean scores comparing with other barriers in different categories. These data were interpreted for elaborating of SWOT and TOWS matrix to highlight strengths, weaknesses, threats and opportunities. Accordingly, ten policies were recommended for improvement of practicing waste minimization by manufacturing firms as the main aim of this research. Implications This manuscript critically analysis waste minimization practices by manufacturing firms in Malaysia. Both qualitative and quantitative data collection and analysis were conducted to formulate SWOT and TOWS matrix in order to recommend policies and strategies for improvement of solid waste minimization by manufacturing industries

  14. Maladaptive sleep hygiene practices in good sleepers and patients with insomnia.

    PubMed

    Yang, Chien-Ming; Lin, Shih-Chun; Hsu, Shih-Chieh; Cheng, Chung-Ping

    2010-01-01

    Previous studies examining the associations between sleep hygiene practices and insomnia have produced inconsistent results. This study further investigates this issue by examining different domains of sleep hygiene separately. One hundred and six insomnia patients and 89 good sleepers participated in the study. Their sleep hygiene, sleep quality and insomnia severity were assessed with subjective rating scales. Among good sleepers, almost all domains of sleep hygiene correlated significantly with their sleep ratings. However, in insomnia patients, only the arousal-related behavior correlated with sleep ratings. The findings suggest that strategies in prevention and treatment of sleep disturbance may be different accordingly.

  15. Guide to good practices for training and qualification of instructors: DOE guideline

    SciTech Connect

    Not Available

    1991-11-01

    The purpose of the Guide to Good Practices for Training and Qualification of Instructors is to provide contractor training organizations with information that can be used to verify the adequacy of and/or modify existing instructor training programs, or to develop new training programs. DOE contractors should not feel obligated to adopt all parts of this document. Rather, they can use the information contained in these good practices to develop programs that are applicable to their facility. This guide applies primarily to those who conduct and support technical instruction in the areas of facility operations maintenance and technical support. However, human resource development (HRD) instructors may also find its content useful. While this document treats an instructor`s technical and instructional competence separately, it is the combination of these factors and interpersonal skills that produces a highly effective instructor.

  16. Guide to good practices for training and qualification of instructors: DOE guideline

    SciTech Connect

    Not Available

    1991-11-01

    The purpose of the Guide to Good Practices for Training and Qualification of Instructors is to provide contractor training organizations with information that can be used to verify the adequacy of and/or modify existing instructor training programs, or to develop new training programs. DOE contractors should not feel obligated to adopt all parts of this document. Rather, they can use the information contained in these good practices to develop programs that are applicable to their facility. This guide applies primarily to those who conduct and support technical instruction in the areas of facility operations maintenance and technical support. However, human resource development (HRD) instructors may also find its content useful. While this document treats an instructor's technical and instructional competence separately, it is the combination of these factors and interpersonal skills that produces a highly effective instructor.

  17. Guide to good practices for on-the-job training. DOE guideline

    SciTech Connect

    Not Available

    1992-07-01

    The purpose of the Department of Energy (DOE) Guide to Good Practices for On-the-Job Training (OJT) is to provide DOE contractor organizations with information that can be used to modify existing programs or to develop new programs. This guide replaces the Guide to Good Practices for On-the-Job Training that was distributed to DOE and DOE contractors in 1987. DOE contractors should not feel obligated to adopt all parts of this guide. Rather, they can use the information in this guide to develop programs that apply to their facility. This guide can be used as an aid in the design and development of a facility`s OJT programs and to assist the instructors who conduct OJT and performance tests in the areas of facility operations, maintenance, and technical supports.

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  20. A systematic approach to initial data analysis is good research practice.

    PubMed

    Huebner, Marianne; Vach, Werner; le Cessie, Saskia

    2016-01-01

    Initial data analysis is conducted independently of the analysis needed to address the research questions. Shortcomings in these first steps may result in inappropriate statistical methods or incorrect conclusions. We outline a framework for initial data analysis and illustrate the impact of initial data analysis on research studies. Examples of reporting of initial data analysis in publications are given. A systematic and careful approach to initial data analysis is needed as good research practice.

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

    SciTech Connect

    1996-03-01

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

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

    PubMed

    Carroll, Erica Eggers

    2016-01-01

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

  3. High ear-piercing: an increasingly popular procedure with serious complications. Is good clinical practice exercised?

    PubMed

    Lyons, Marie; Stephens, Joanna; Wasson, Joseph; DeZoysa, Nilantha; Vlastarakos, Petros V

    2012-03-01

    This study aimed to explore the current practice of performing high ear-piercing regarding consent protocols, and methods of practice using questionnaire-based survey in Hertfordshire and North London. Recommendations for good clinical practice are also made. 100 establishments performing ear piercing were identified. A 16-item questionnaire on techniques used, methods of high-ear piercing, methods of sterilization, consent issues and aftercare was completed. Seventy-six establishments agreed to participate. All practitioners prepared the skin before piercing. 58 (76%) used a needle for piercing, 11 (15%) used a spring-loaded gun and seven (9%) used both. 97% of the practitioners obtained written consent before proceeding. 9 (12%) had a lower age limit of 16 years and three (4%) of 18 years. 27 piercers (36%) provided an aftercare leaflet, 41 (54%) warned the patients about risks of infection, 16 (21%) warned about cosmetic deformity and 1 (1%) specifically mentioned cauliflower ear. Results indicated that high ear piercing is an invasive procedure with a significant risk of complications leading to cosmetic deformity. Establishments should be required to counsel patients properly about the risks and potential complications of the procedure. A code of practice should be drawn up with a minimum age for piercing, requirement for proper consent, excellent hygiene and good information for postoperative care.

  4. 2 CFR 176.150 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... and Reinvestment Act of 2009 § 176.150 Notice of Required Use of American Iron, Steel, and..., maintenance, or repair of a public building or public work, and do not involve iron, steel,...

  5. 2 CFR 176.150 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... and Reinvestment Act of 2009 § 176.150 Notice of Required Use of American Iron, Steel, and..., maintenance, or repair of a public building or public work, and do not involve iron, steel,...

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

    PubMed

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

    2015-11-01

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

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

    PubMed

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

    2015-12-01

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

  8. Computer ergonomics: the medical practice guide to developing good computer habits.

    PubMed

    Hills, Laura

    2011-01-01

    Medical practice employees are likely to use computers for at least some of their work. Some sit several hours each day at computer workstations. Therefore, it is important that members of your medical practice team develop good computer work habits and that they know how to align equipment, furniture, and their bodies to prevent strain, stress, and computer-related injuries. This article delves into the field of computer ergonomics-the design of computer workstations and work habits to reduce user fatigue, discomfort, and injury. It describes practical strategies medical practice employees can use to improve their computer work habits. Specifically, this article describes the proper use of the computer workstation chair, the ideal placement of the computer monitor and keyboard, and the best lighting for computer work areas and tasks. Moreover, this article includes computer ergonomic guidelines especially for bifocal and progressive lens wearers and offers 10 tips for proper mousing. Ergonomically correct posture, movements, positioning, and equipment are all described in detail to enable the frequent computer user in your medical practice to remain healthy, pain-free, and productive.

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

    SciTech Connect

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

    1988-05-01

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

  10. Team Science Approach to Developing Consensus on Research Good Practices for Practice-Based Research Networks: A Case Study.

    PubMed

    Campbell-Voytal, Kimberly; Daly, Jeanette M; Nagykaldi, Zsolt J; Aspy, Cheryl B; Dolor, Rowena J; Fagnan, Lyle J; Levy, Barcey T; Palac, Hannah L; Michaels, LeAnn; Patterson, V Beth; Kano, Miria; Smith, Paul D; Sussman, Andrew L; Williams, Robert; Sterling, Pamela; O'Beirne, Maeve; Neale, Anne Victoria

    2015-12-01

    Using peer learning strategies, seven experienced PBRNs working in collaborative teams articulated procedures for PBRN Research Good Practices (PRGPs). The PRGPs is a PBRN-specific resource to facilitate PBRN management and staff training, to promote adherence to study protocols, and to increase validity and generalizability of study findings. This paper describes the team science processes which culminated in the PRGPs. Skilled facilitators used team science strategies and methods from the Technology of Participation (ToP®), and the Consensus Workshop Method to support teams to codify diverse research expertise in practice-based research. The participatory nature of "sense-making" moved through identifiable stages. Lessons learned include (1) team input into the scope of the final outcome proved vital to project relevance; (2) PBRNs with diverse domains of research expertise contributed broad knowledge on each topic; and (3) ToP® structured facilitation techniques were critical for establishing trust and clarifying the "sense-making" process.

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

    PubMed

    Asai, Satomi; Miyachi, Hayato

    2015-07-01

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

  12. Theory and practice for the manufacture of a composite thermal heat shield for a space ship

    NASA Astrophysics Data System (ADS)

    Tarasov, V. A.; Komkov, M. A.; Romanenkov, V. A.; Alyamovsky, A. I.; Kopyl, N. I.; Boyarskaya, R. V.

    2016-10-01

    The technological processes were explored for the manufacture in an autoclave of a space ship heat shield. A mathematical model was created for the determination of the duration of the impregnation of the binder for the composite material. The change in the Nitrogen content is dependent on the time in the autoclave. This dependence relates to the use of the minimum amount of electricity to reduce the expense of the process in practice.

  13. U.S. Coast Guard, Maintenance and Logistics Command-Atlantic, Norfolk, VA. Best Manufacturing Practices

    DTIC Science & Technology

    2002-04-29

    by identifying, researching, and promoting exceptional manufacturing practices, methods, and procedures in design, test, production, facilities...nating non value-added tasks and acts as a catalyst for implementing new technologies to improve its mission to "Keep Coast Guard units and personnel in ...This continual updating process ultimately ensures the accuracy of the new estimates. In addition, the process helps ensure that contracting personnel

  14. Implementation of VOC source reduction practices in a manufactured house and in school classrooms

    SciTech Connect

    Hodgson, A.T.; Apte, M.G.; Shendell, D.G.; Beal, D.; McIlvaine, J.E.R.

    2002-01-01

    Detailed studies of a new manufactured house and four new industrialized relocatable school classrooms were conducted to determine the emission sources of formaldehyde and other VOCs and to identify and implement source reduction practices. Procedures were developed to generate VOC emission factors that allowed reasonably accurate predictions of indoor air VOC concentrations. Based on the identified sources of formaldehyde and other aldehydes, practices were developed to reduce the concentrations of these compounds in new house construction. An alternate ceiling panel reduced formaldehyde concentrations in the classrooms. Overall, the classrooms had relatively low VOC concentrations.

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

    PubMed

    Miller, Jennifer E

    2013-01-01

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

  16. 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…

  17. Good practice guidelines for clinical psychologists working in paediatric cochlear implant teams.

    PubMed

    Bathgate, Fionna; Bennett, Emily; Cropper, Jenny; Edwards, Lindsey; Emond, Alice; Gamble, Caroline; Kentish, Rosie; Samuel, Victoria

    2013-11-01

    There are relatively few clinical psychologists working in paediatric cochlear implant centres in the UK and in this respect we lag behind other countries such as the USA and The Netherlands. In an effort to promote the added value our profession can offer teams, the clinical psychologists working in paediatric CI centres have put together good practice guidelines. This article outlines the rationale for putting together the guidelines, highlights the unique contribution clinical psychologists can offer, outlines the evidence base for psychological input in this clinical population, and offers a fictional case study for illustration.

  18. The primary care of patients with schizophrenia: a search for good practice.

    PubMed Central

    Burns, T; Kendrick, T

    1997-01-01

    The proportion of patients with schizophrenia who lose contact with the secondary services is between 25% and 40%. The general practitioner remains the health care professional most likely to be in contact with such patients. A consensus group of 14 members met on four occasions, reviewed the relevant literature, and developed good-practice guidelines in five areas: establishing a register and organizing regular reviews; comprehensive assessments; information and advice for patients and carers; indications for involving specialist services; and crisis management. The guidelines are presented and their supporting evidence summarized. PMID:9302795

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

    SciTech Connect

    Not Available

    1993-03-01

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

  20. Application of good laboratory practice (GLP) to culture collections of microbial and cell cultures.

    PubMed

    Stevenson, R E; Jong, S C

    1992-05-01

    Although the principles and the necessity for good laboratory practice (GLP) guidelines to confirm the credibility, integrity, and quality of non-clinical laboratory studies have been known for more than a decade, culture collection activities are not subject to them. Because of recent advances in biotechnology, culture collections face increased demands not only for quality cultures but also current information. When applied in culture collections, GLP guidelines prove to be an excellent management tool as well as a cost-effective system of providing authentic and reliable microbial and cell cultures and associated data.

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

    SciTech Connect

    1998-12-01

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

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

    SciTech Connect

    Not Available

    1993-06-01

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

  3. Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Final rule.

    PubMed

    2004-11-24

    The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation.

  4. Aspherical manufacturing in terms of accuracy, efficiency, and surface forms based on practical experiences

    NASA Astrophysics Data System (ADS)

    Kiontke, Sven R.; Steinkopf, Ralf

    2008-09-01

    Within the past ten years a variety of CNC manufacturers for aspherical surfaces have been established. The field of applications they are working for are very different. The way CNC manufacturers measure surfaces as well as the way they characterize the surface form deviation differs even more. Furthermore, there are a lot of customers being interested in using aspherical surfaces in their applications. In fact, aspherical lenses are not established as standard optical elements yet which is due to the fact that many users are not familiar with the implications of the use of aspherical surfaces with respect to the tolerancing of the optical system. Only few know how to specify an asphere, moreover, they differ about how to do that. The paper will give an insight in what is possible in aspherical manufacturing in terms of accuracy, efficiency, number of pieces per design and surface forms. An important issue is the development of deviation of form and slope in connection to prepolishing and correction polishing. Based on experiences of the manufacture of more than 500 different aspherical designs with diameters ranging from 3 - 200 mm, the paper is going to give an insight into production practices. Finally, there will be a general overview on what could be done and what needs to be done in order to unify the different ways of tolerancing of aspherical surfaces.

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

    PubMed

    Bentley, R E

    1995-12-01

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

  6. [Good cell culture practice--implementation of a relational cell culture database].

    PubMed

    Philipp, Marcel O; Falkner, Erwin; Kapeller, Barbara; Eberl, Heidrun; Frick, Wolfram; Macfelda, Karin; Losert, Udo M

    2002-01-01

    The claim for cell culture to provide validable in vitro models for biomedical research postulates evasion of possible fatal record keeping errors. A prototype of a relational computer database for IBM-compatible personal computers using Microsoft(r) Windows 95/98/2000 and NT for administration of cell culture data has been developed using Microsoft(r) Access 98 (Microsoft Corporation, Redmond, USA), -Access Basic, -Visual Basic and Structured Query Language (SQL) (IBM Corporation, Armonk, USA), and was tested successfully. The modular software application manages the many aspects of cell culture laboratory record keeping like detailed information on tissue donor, primary cell isolation/cell line origin, immunohistochemical/molecular biological characterisation, cell countings at passaging/subcultivation/cell aliquotation and cryopreservation. One main feature is a collection of all methods performed at our cell culture laboratory, where linked tables and files store specific informations. Entries into the database are checked via validation rules for correctness to avoid mistakes. The developed prototype has been demonstrated to be an adaptable, reliable tool for improving quality of information storage according to Good Scientific Practice (GSP), Good Cell Culture Practice (GCCP) and general ISO certification trends.

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

    PubMed

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

    2014-07-01

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

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

    PubMed

    2012-04-06

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

  9. Practical Education Support to Foster Engineers at Manufacturing and Engineering Design Center in Muroran Institute of Technology

    NASA Astrophysics Data System (ADS)

    Kazama, Toshiharu; Hanajima, Naohiko; Shimizu, Kazumichi; Satoh, Kohki

    To foster engineers with creative power, Muroran Institute of Technology established Manufacturing and Engineering Design Center (MEDeC) that concentrates on Monozukuri. MEDeC consists of three project groups : i) Education Support Group provides educational support for practical training classes on and off campus and PDCA (plan-do-check-action) -conscious engineering design education related to Monozukuri ; ii) Fundamental Manufacturing Research Group carries out nurture research into fundamental and innovative technology of machining and manufacturing, and iii) Regional Cooperation Group coordinates the activities in cooperation with bureau, schools and industries in and around Muroran City. MEDeC has a fully integrated collection of machine tools and hand tools for manufacturing, an atelier, a tatara workplace, implements for measurement and related equipment designed for practically teaching state-of-the-practice manufacturing methods.

  10. 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…

  11. Do clinical practice guidelines define good medical care? The need for good science and the disclosure of uncertainty when defining 'best practices'.

    PubMed

    Woolf, S H

    1998-03-01

    Practice guidelines, although important in promoting quality, can also be harmful if they do not advocate the best options for patients. The latter can occur because of uncertainties in scientific evidence, biases in guideline development, and patient heterogeneity. Guidelines must therefore accurately describe the quality of the evidence and the degree of uncertainty that underlie recommendations. Proper methods for developing practice guidelines are reviewed.

  12. Person-centric clinical trials: an opportunity for the good clinical practice (GCP)-practice-based research network.

    PubMed

    Curro, Frederick A; Robbins, Dennis A; Millenson, Michael L; Fox, Chester H; Naftolin, Frederick

    2013-10-01

    Practice-based research networks (PBRNs) can function as a platform for delivery of patient-centered care consistent with the Patient Protection and Affordable Care Act. Patient-centered (centric) clinical studies encourage the patient to be an integral part of study design and outcome. The patient's electronic health record contributes to the shared national health care data set. PBRNs integrate health care data in real time at the point of care and reflect the full context of the person's health. PBRNs designed under the principles of good clinical practice (GCP) validate studies related to comparative effectiveness research and drug development. PBRNs can generate large amounts of data from known patient histories so that side effects can be assessed in their totality. The larger and more diverse number of patients recruited suggests that point-of-care-data, where both provider and patient participate in the treatment, may be more robust in that side effects, drug-drug interactions and number of concomitant medications used may be identified earlier in the development process. The GCP PBRN concept affords continuous patient information for both care and research purposes. These all contribute to an ethical approach for the pharmaceutical industry to generate clinical research data for regulatory submission and to contribute to a HIPAA-compliant national database that could contribute to improved health care delivery and pharmacovigilance.

  13. The good, the bad and the ugly: the practical consequences of centrosome amplification.

    PubMed

    Sluder, Greenfield; Nordberg, Joshua J

    2004-02-01

    Centrosome amplification (the presence of more than two centrosomes at mitosis) is characteristic of many human cancers. Extra centrosomes can cause the assembly of multipolar spindles, which unequally distribute chromosomes to daughter cells; the resulting genetic imbalances may contribute to cellular transformation. However, this raises the question of how a population of cells with centrosome amplification can survive such chaotic mitoses without soon becoming non-viable as a result of chromosome loss. Recent observations indicate that a variety of mechanisms partially mute the practical consequences of centrosome amplification. Consequently, populations of cells propagate with good efficiency, despite centrosome amplification, yet have an elevated mitotic error rate that can fuel the evolution of the transformed state.

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

    PubMed

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

    2016-07-01

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

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

    PubMed

    Aizaki, Hideo; Nanseki, Teruaki; Zhou, Hui

    2013-01-01

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

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

    PubMed

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

    2016-01-01

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

  17. The importance of Good Clinical Practice guidelines and its role in clinical trials

    PubMed Central

    Vijayananthan, A; Nawawi, O

    2008-01-01

    Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we address the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights. PMID:21614316

  18. Protein sequence comparison and fold recognition: progress and good-practice benchmarking.

    PubMed

    Söding, Johannes; Remmert, Michael

    2011-06-01

    Protein sequence comparison methods have grown increasingly sensitive during the last decade and can often identify distantly related proteins sharing a common ancestor some 3 billion years ago. Although cellular function is not conserved so long, molecular functions and structures of protein domains often are. In combination with a domain-centered approach to function and structure prediction, modern remote homology detection methods have a great and largely underexploited potential for elucidating protein functions and evolution. Advances during the last few years include nonlinear scoring functions combining various sequence features, the use of sequence context information, and powerful new software packages. Since progress depends on realistically assessing new and existing methods and published benchmarks are often hard to compare, we propose 10 rules of good-practice benchmarking.

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

    SciTech Connect

    1999-04-01

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

  20. Social welfare in Mental Health Department for a Good clinical practice.

    PubMed

    Amorosi, Marilisa

    2016-09-01

    The National Plan of Action for Mental Health (PANSM), approved by the Conference of Regions has been from January 24 2013, being implemented by the Department of Mental Health Services. It requires a reorganization of the same, the functional the adoption of a methodology based on the Necessity of Working for projects which are Intervention-specific and differentiated, based on the evaluation of the need and patients and the implementation of care pathways. This implies a systemic approach by of the team, rather than a segmental working mode. Thus change is necessary in the work culture of the teams, and from the State Regions Conference November 13 2014, has emerged the need to share, among all stakeholders, good practices and the development of Clinical Management Tools so that standards of care can be defined to ensure quality, together with the measurement of Processes and Outcomes.

  1. Applying the Good Laboratory Practice regulations to studies involving genetically modified plants.

    PubMed

    Holden, D E

    1995-12-01

    How can the Environmental Protection Agency's Good Laboratory Practice (GLP) regulations, originally written primarily for mammalian toxicology studies, be applied to regulatory studies conducted for genetically modified plants? Do they fit? Can they be applied and still make sense? How is a Quality Assurance Unit (QAU) to interpret the requirements in this new area of biotechnology? The answers to these questions are discussed in this brief presentation of how one team within the Monsanto QAU, along with the researchers, developed am effective and comprehensive compliance program by applying the "traditional approach" to the GLP regulations to a new and important scientific field in regulatory compliance. Topics discussed will address the differences in the approach between traditional toxicity testing and the newer technology and how the differences were resolved, new and innovative definitions of particular phases and other aspects of regulatory studies, and how the draft regulations for pesticidal plants will help this area of technology in the future.

  2. Computer validation in toxicology: historical review for FDA and EPA good laboratory practice.

    PubMed

    Brodish, D L

    1998-01-01

    The application of computer validation principles to Good Laboratory Practice is a fairly recent phenomenon. As automated data collection systems have become more common in toxicology facilities, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency have begun to focus inspections in this area. This historical review documents the development of regulatory guidance on computer validation in toxicology over the past several decades. An overview of the components of a computer life cycle is presented, including the development of systems descriptions, validation plans, validation testing, system maintenance, SOPs, change control, security considerations, and system retirement. Examples are provided for implementation of computer validation principles on laboratory computer systems in a toxicology facility.

  3. [The Italian inspection system for good laboratory practice: structure and updates].

    PubMed

    Capasso, Monica

    2002-01-01

    The Italian inspecting system for compliance with the good laboratory practice (GLP) principles is fully operative since late 1996. Over these past years documents have been issued and specific guidelines have been worked out to properly perform the activities prescribed. This preparatory work has allowed the Italian system to harmonize with those of the other member states of the European Union. In the frame of other international activities, the Italian Inspectorate has participated in the mutual joint visits programme set up by OECD. Much effort has been invested to pinpoint differences in the approaches followed by the various Italian inspecting teams when inspecting test facilities. From this standpoint, the priority was the attainment of reliable information as well as of solutions that would allow the harmonization of the conduct of GLP inspections. It cannot be overlooked, in fact, that there are 24 inspectors, to whom a substantial number of experts has to be added.

  4. Practical aspects of modern interferometry for optical manufacturing quality control: Part 1

    NASA Astrophysics Data System (ADS)

    Smythe, Robert

    2012-03-01

    Modern phase shifting interferometers enable the manufacture of optical systems that drive the global economy. Semiconductor chips, solid-state cameras, cell phone cameras, infrared imaging systems, space based satellite imaging and DVD and Blu-Ray disks are all enabled by phase shifting interferometers. Theoretical treatments of data analysis and instrument design advance the technology but often are not helpful towards the practical use of interferometers. An understanding of the parameters that drive system performance is critical to produce useful results. Any interferometer will produce a data map and results; this paper reviews some of the key issues to minimize error sources in that data and provide a valid measurement.

  5. Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency.

    PubMed

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

    2016-07-01

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

  6. Good practice guidelines for the use of statistical regression models in economic evaluations.

    PubMed

    Kearns, Ben; Ara, Roberta; Wailoo, Allan; Manca, Andrea; Alava, Monica Hernández; Abrams, Keith; Campbell, Mike

    2013-08-01

    Decision-analytic models (DAMs) used to evaluate the cost effectiveness of interventions are pivotal sources of evidence used in economic evaluations. Parameter estimates used in the DAMs are often based on the results of a regression analysis, but there is little guidance relating to these. This study had two objectives. The first was to identify the frequency of use of regression models in economic evaluations, the parameters they inform, and the amount of information reported to describe and support the analyses. The second objective was to provide guidance to improve practice in this area, based on the review. The review concentrated on a random sample of economic evaluations submitted to the UK National Institute for Health and Clinical Excellence (NICE) as part of its technology appraisal process. Based on these findings, recommendations for good practice were drafted, together with a checklist for critiquing reporting standards in this area. Based on the results of this review, statistical regression models are in widespread use in DAMs used to support economic evaluations, yet reporting of basic information, such as the sample size used and measures of uncertainty, is limited. Recommendations were formed about how reporting standards could be improved to better meet the needs of decision makers. These recommendations are summarised in a checklist, which may be used by both those conducting regression analyses and those critiquing them, to identify what should be reported when using the results of a regression analysis within a DAM.

  7. Standardized cell sources and recommendations for good cell culture practices in genotoxicity testing.

    PubMed

    Lorge, E; Moore, M M; Clements, J; O'Donovan, M; Fellows, M D; Honma, M; Kohara, A; Galloway, S; Armstrong, M J; Thybaud, V; Gollapudi, B; Aardema, M J; Tanir, J Y

    2016-10-01

    Good cell culture practice and characterization of the cell lines used are of critical importance in in vitro genotoxicity testing. The objective of this initiative was to make continuously available stocks of the characterized isolates of the most frequently used mammalian cell lines in genotoxicity testing anywhere in the world ('IVGT' cell lines). This project was organized under the auspices of the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) Project Committee on the Relevance and Follow-up of Positive Results in In Vitro Genetic Toxicity (IVGT) Testing. First, cell isolates were identified that are as close as possible to the isolate described in the initial publications reporting their use in genotoxicity testing. The depositors of these cell lines managed their characterization and their expansion for preparing continuously available stocks of these cells that are stored at the European Collection of Cell Cultures (ECACC, UK) and the Japanese Collection of Research Bioresources (JCRB, Japan). This publication describes how the four 'IVGT' cell lines, i.e. L5178Y TK(+/-) 3.7.2C, TK6, CHO-WBL and CHL/IU, were prepared for deposit at the ECACC and JCRB cell banks. Recommendations for handling these cell lines and monitoring their characteristics are also described. The growth characteristics of these cell lines (growth rates and cell cycles), their identity (karyotypes and genetic status) and ranges of background frequencies of select endpoints are also reported to help in the routine practice of genotoxicity testing using these cell lines.

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

    NASA Astrophysics Data System (ADS)

    Masaitis, Alexandra

    2014-05-01

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

  9. [Legal value of the recomendations of good practice: example for breast cancer hormonotherapy].

    PubMed

    Delpous, Stéphanie; Benhessa, Ghislain; Bilalis, Alexandre; Tomasetto, Catherine; Mathelin, Carole

    2014-03-01

    On April 27th 2011, the French Supreme Administrative Court (Conseil d'État) granted the Recommendations for Good Practice set out by the French National Authority for Health (Haute Autorité de santé--[HAS]) a legal status, considering that they "must be regarded as (…) decisions which may be subject to an action for annulment". The judge came to this conclusion through a quasi-syllogistic reasoning. Firstly, the French Code of Medical Ethics requires physicians to care for their patients in accordance with established scientific knowledge. Secondly, the HAS recommendations recall in particular this established scientific knowledge. Treating patients according to established scientific knowledge requires then that physicians follow the HAS recommendations. While the case at bar does not directly involve liability for medical malpractice-since the applicant only sought to have an HAS recommendation declared void-it is nonetheless necessary to examine the impact of this ruling for health professionals. Indeed, this decision raises a number of concerns for everyday medical practice. Guidelines concerning the endocrine treatment of hormonodependant breast cancers are plentiful. In January 2010, the HAS and the French National Institute for Cancer (Institut national du cancer) issued a "Guide for long-term illnesses-Breast cancer" (Guide ALD - Cancer du sein). In addition to these nation-wide guidelines, the Regional Networks for Cancer (réseaux régionaux de cancérologie) issued their own recommendations. Other guidelines are also set out in the framework of consensus conferences, such as the Nice Saint-Paul-de-Vence (France) and St. Gallen (Switzerland) conferences. In the United States, the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO), and in Europe, the European Society of Medical Oncology (ESMO) make recommendations as well. Therefore, the HAS recommendations are hardly the sole source of information for

  10. Good Practices in Undergraduate Education from the Students' and Faculty's View: Consensus or Disagreement. AIR 1996 Annual Forum Paper.

    ERIC Educational Resources Information Center

    Negron-Morales, Patricia; And Others

    This study examined teaching practices in undergraduate education by surveying 180 undergraduate students and 29 faculty, most in the school of education, at the Rio Piedras Campus of the University of Puerto Rico. Factors investigated include: (1) degree of agreement between faculty and students on good teaching practices; (2) relationship…

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

    PubMed

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

    2012-03-01

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

  12. DOE handbook: Guide to good practices for training and qualification of maintenance personnel

    SciTech Connect

    1996-03-01

    The purpose of this Handbook is to provide contractor training organizations with information that can be used to verify the adequacy of and/or modify existing maintenance training programs, or to develop new training programs. This guide, used in conjunction with facility-specific job analyses, provides a framework for training and qualification programs for maintenance personnel at DOE reactor and nonreactor nuclear facilities. Recommendations for qualification are made in four areas: education, experience, physical attributes, and training. The functional positions of maintenance mechanic, electrician, and instrumentation and control technician are covered by this guide. Sufficient common knowledge and skills were found to include the three disciplines in one guide to good practices. Contents include: qualifications; on-the-job training; trainee evaluation; continuing training; training effectiveness evaluation; and program records. Appendices are included which relate to: administrative training; industrial safety training; fundamentals training; tools and equipment training; facility systems and component knowledge training; facility systems and component skills training; and specialized skills training.

  13. A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure.

    PubMed

    Adamo, Joan E; Bauer, Gerhard; Berro, Marlene; Burnett, Bruce K; Hartman, Karen A; Masiello, Lisa M; Moorman-White, Diane; Rubinstein, Eric P; Schuff, Kathryn G

    2012-03-01

    Prior to human clinical trials, nonclinical safety and toxicology studies are required to demonstrate that a new product appears safe for human testing; these nonclinical studies are governed by good laboratory practice (GLP) regulations. As academic health centers (AHCs) embrace the charge to increase the translation of basic science research into clinical discoveries, researchers at these institutions increasingly will be conducting GLP-regulated nonclinical studies. Because the consequences for noncompliance are severe and many AHC researchers are unfamiliar with Food and Drug Administration regulations, the authors describe the regulatory requirements for conducting GLP research, including the strict documentation requirements, the necessary personnel training, the importance of study monitoring, and the critical role that compliance oversight plays in the process. They then explain the process that AHCs interested in conducting GLP studies should take before the start of their research program, including conducting a needs assessment and a gap analysis and selecting a model for GLP compliance. Finally, the authors identify and analyze several critical barriers to developing and implementing a GLP-compliant infrastructure at an AHC. Despite these challenges, the capacity to perform such research will help AHCs to build and maintain competitive research programs and to facilitate the successful translation of faculty-initiated research from nonclinical studies to first-in-human clinical trials.

  14. The good pharmacy practice on Einstein Program at Paraisópolis Community

    PubMed Central

    de Oliveira, Lara Tânia de Assumpção Domingues Gonçalves; da Silva, Camila Pontes; Guedes, Maria das Vitorias; Sousa, Ana Célia de Oliveira; Sarno, Flávio

    2016-01-01

    ABSTRACT Objectives: To describe indicators and processes developed and implemented for pharmaceutical assistance at the Einstein Program at Paraisópolis Community pharmacy. Methods: This was a descriptive study of retrospective data from January 2012 to December 2015. Data were obtained from spreadsheets developed for monitoring the productivity and care quality provided at the pharmacy. The evaluated variables were pharmaceutical assistance to prescription, pharmaceutical intervention, orientation (standard and pharmaceutical) and pharmaceutical orientation rate. Results: The pharmacy assisted, on average, 2,308 prescriptions monthly, dispensing 4,871 items, including medications, materials and food supplements. Since March 2015, virtually, the pharmacist analyzed all prescriptions, prior to dispensing. In the analyzed period, there was an increase in monthly pharmaceutical interventions from 7 to 32 on average, and, although there was a decrease in the number of standard orientation, the pharmaceutical orientation had an increase, causing a rise of pharmaceutical orientation rate from 4 to 11%. Conclusion: The processes developed and implemented at the program pharmacy sought to follow the good pharmacy practice, and help patients to make the best use of their medications. PMID:27759833

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

    PubMed Central

    Berer, M.

    2000-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  17. [Ecological agriculture: future of Good Agriculture Practice of Chinese materia medica].

    PubMed

    Guo, Lan-ping; Zhou, Liang-yun; Mo, Ge; Wang, Sheng; Huang, Lu-qi

    2015-09-01

    Based on the ecological and economic problems in Good Agriculture Practice (GAP) of Chinese material medica, we introduced the origin, concept, features and operative technology of eco-agriculture worldwide, emphasizing its modes on different biological levels of landscape, ecosystem, community, population, individual and gene in China. And on this basis, we analyzed the background and current situation of eco-agriculture of Chinese materia medica, and proposed its development ideas and key tasks, including: (1) Analysis and planning of the production pattern of Chinese material medica national wide. (2) Typical features extraction of regional agriculture of Chinese materia medica. (3) Investigation of the interaction and its mechanism between typical Chinese materia medica in each region and the micro-ecology of rhizosphere soil. (4) Study on technology of eco-agriculture of Chinese materia medica. (5) Extraction and solidification of eco-agriculture modes of Chinese materia medica. (6) Study on the theory of eco-agriculture of Chinese materia medica. Also we pointed out that GAP and eco-agriculture of Chinese material medica are both different and relative, but they are not contradictory with their own features. It is an irresistible trend to promote eco-agriculture in the GAP of Chinese material medica and coordinate ecological and economic development.

  18. Guide to good practices for the selection, training, and qualification of shift technical advisors

    SciTech Connect

    Not Available

    1993-02-01

    The DOE Guide to Good Practices For The Selection, Training, and Qualification of Shift Technical Advisors can be used by any DOE nuclear facility that has implemented the shift technical advisor position. DOE Order 5480-20, ``Personnel Selection, Qualification, Training, and Staffing Requirements at DOE Reactor and Non-Reactor Nuclear Facilities,`` states that only Category A reactors must use shift technical advisor position. However, many DOE nuclear facilities have implemented the shift technical advisor position to provide independent on-shift technical advice and counsel to the shift operating personnel to help determine cause and mitigation of facility accidents. Those DOE nuclear facilities that have implemented or are going to implement the shift technical advisor position will find this guide useful. This guide addresses areas that may be covered by other training programs. In these cases, it is unnecessary (and undesirable) to duplicate these areas in the STA training program as long as the specific skills and knowledge essential for STAs are addressed. The guide is presented based on the premise that the trainee has not completed any facility-specific training other than general employee training.

  19. The OECD policy for the implementation of the principles of good laboratory practice.

    PubMed

    Turnheim, D

    1994-01-01

    OECD has been involved in the harmonisation of policies and instruments for chemicals control since the late 1970's. The OECD principles of good laboratory practice (GLP) were developed and subsequently adopted by the Council in 1981. These principles have the primary objective of ensuring the generation of high quality test data. They set out managerial concepts covering the organisation of test laboratories as well as the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. A system of compliance monitoring procedures has been established to ensure that laboratory studies are carried out in member countries according to the principles of GLP. The harmonization and mutual recognition of compliance monitoring methods among member countries have been a crucial step in ensuring the international acceptability of data. This undertaking involved the development of consistent criteria for determining whether a laboratory conducts studies in accordance with the principles of GLP. Training courses are held for GLP inspectors, an activity which lies at the basis of harmonising monitoring procedures. Consensus workshops result in consensus documents on the harmonised application and interpretation of the GLP principles in specific areas or on specific points. This system makes it possible for countries to speak the same language when exchanging information about specific laboratories, and to have confidence in the quality and rigour of safety tests undertaken in a laboratory.

  20. Guide to good practices for the selection, training, and qualification of shift technical advisors

    SciTech Connect

    1993-02-01

    The DOE Guide to Good Practices For the Selection, Training, and Qualification of Shift Technical Advisors can be used by any DOE nuclear facility that has implemented the shift technical advisor (STA) position. DOE Order 5480.20A, Personnel Selection, Qualification and Training Requirements for DOE Nuclear Facilities, states that only Category A reactors must have a shift technical advisor. However, many DOE nuclear facilities have implemented the shift technical advisor position to provide independent on-shift technical advice and counsel to the shift operating personnel to help determine cause and mitigation of facility accidents. Those DOE nuclear facilities that have implemented or are going to implement the shift technical advisor position will find this guide useful. This guide addresses areas that may be covered by other training programs. In these cases, it is unnecessary (and undesirable) to duplicate these areas in the STA training program as long as the specific skills and knowledge essential for STAs are addressed. The guide is based on the premise that the trainee has not completed any facility-specific training other than general employee training.

  1. 21 CFR 111.210 - What must the master manufacturing record include?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What must the master manufacturing record include... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...: Requirements for the Master Manufacturing Record § 111.210 What must the master manufacturing record...

  2. 21 CFR 111.210 - What must the master manufacturing record include?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What must the master manufacturing record include... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...: Requirements for the Master Manufacturing Record § 111.210 What must the master manufacturing record...

  3. 21 CFR 111.210 - What must the master manufacturing record include?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What must the master manufacturing record include... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...: Requirements for the Master Manufacturing Record § 111.210 What must the master manufacturing record...

  4. 21 CFR 111.210 - What must the master manufacturing record include?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What must the master manufacturing record include... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...: Requirements for the Master Manufacturing Record § 111.210 What must the master manufacturing record...

  5. 21 CFR 111.210 - What must the master manufacturing record include?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What must the master manufacturing record include... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...: Requirements for the Master Manufacturing Record § 111.210 What must the master manufacturing record...

  6. 75 FR 40840 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-14

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION:...

  7. Practical aspects of modern interferometry for optical manufacturing quality control: Part 2

    NASA Astrophysics Data System (ADS)

    Smythe, Robert

    2012-07-01

    Modern phase shifting interferometers enable the manufacture of optical systems that drive the global economy. Semiconductor chips, solid-state cameras, cell phone cameras, infrared imaging systems, space based satellite imaging and DVD and Blu-Ray disks are all enabled by phase shifting interferometers. Theoretical treatments of data analysis and instrument design advance the technology but often are not helpful towards the practical use of interferometers. An understanding of the parameters that drive system performance is critical to produce useful results. Any interferometer will produce a data map and results; this paper, in three parts, reviews some of the key issues to minimize error sources in that data and provide a valid measurement.

  8. A Review of Supply Chain Collaboration Practices for Small and Medium-sized Manufacturers

    NASA Astrophysics Data System (ADS)

    Wee, SY; Thoo, AC; Z, Sulaiman; FM, Muharam

    2016-05-01

    For the decades, organizations have endeavored to look for external sources for opportunities to achieve efficient and responsive supply chain with their partners especially for small and medium manufacturers (SMM). In this scenario, supply chain collaboration (SCC) is an interaction between supply chain members with the purpose of utilizes the knowledge and resources of customers and suppliers, and integrates the flows of products and information in order to achieve a common goal and obtain mutual benefit. The essential SCC dimensions for SMMs comprised of information sharing, joint knowledge creation, joint decision making, goal congruence and incentive sharing. The successful implementation of SCC can give SMMs an edge over their competitors. This paper aims to introduce a review of SCC practices for SMM. Overall, the findings provide managerial insights for the SMM in SCC implementation owing to resource scarcity and the need to draw SCC in order to ensure a sustainable competitive advantage.

  9. [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

  10. 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

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

    PubMed

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

    2014-04-01

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

  12. Mental health advocacy and African and Caribbean men: good practice principles and organizational models for delivery

    PubMed Central

    Newbigging, Karen; McKeown, Mick; French, Beverley

    2011-01-01

    Abstract Background  Advocacy has a critical role to play in addressing concerns about access to appropriate mental health care and treatment for African and Caribbean men. Aim  To investigate good practice principles and organizational models for mental health advocacy provision for African and Caribbean men. Study design  The study consisted of: (i) A systematic literature review. Bibliographic and internet searching was undertaken from 1994 to 2006. The inclusion criteria related to mental health, advocacy provision for African and Caribbean men. (ii) Four focus groups with African and Caribbean men to explore needs for and experiences of mental health advocacy. (iii) An investigation into current advocacy provision through a survey of advocacy provision in England, Wales and Northern Ireland. (iv) Twenty‐two qualitative stakeholder interviews to investigate the operation of mental health advocacy for this client group. The study was undertaken in partnership with two service user‐led organizations and an African Caribbean mental health service. Results  Primary research in this area is scant. Mainstream mental health advocacy services are often poor at providing appropriate services. Services developed by the Black Community and voluntary sector are grounded in different conceptualizations of advocacy and sharper understanding of the needs of African and Caribbean men. The lack of sustainable funding for these organizations is a major barrier to the development of high‐quality advocacy for this group, reflecting a lack of understanding about their distinctive role. Conclusions  The commissioning and provision of mental health advocacy needs to recognize the distinct experiences of African and Caribbean men and develop capacity in the range of organizations to ensure equitable access. PMID:21645185

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

    PubMed Central

    Borgert, Christopher J.; Mihaich, Ellen M.

    2012-01-01

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

  14. The adoption of good laboratory practice principles by Italian test facilities.

    PubMed

    Caroli, S

    1994-01-01

    The principles of good laboratory practice (GLP) can be considered as a code of general behaviour potentially applicable to all experimental studies, although they were first conceived for harmonizing the conduct and assessment of toxicological tests designed to evaluate the impact of chemical substances on human health and the environment. From a general standpoint, therefore, GLP criteria aim at generating credible, comparable and cost-effective experimental information that can in turn make the decision-making process easier and sounder. On the other hand, of equal importance at the global level is the availability of and access to the wealth of critically assessed, self-consistent chemical data thus produced. Under both respects a key role is played by the activities undertaken under the aegis of international bodies such as the Organisation for Economic Cooperation and Development (OECD), the Commission of the European Union (CEU) and the International Register of Potentially Toxic Chemicals of the United Nations Environment Programme (IRPTC-UNEP). This cultural and scientific humus has been incorporated into legal provisions by most industrial countries to regulate production and commercialization of chemical substances. As regards Italy, the act DLvo no. 120 of 27 January 1992 focuses on the adoption of GLP principles by national test facilities and covers all possible categories of chemicals, namely industrial substances, pharmaceuticals, cosmetics, pesticides, food additives and still others. Accordingly, the compliance status with GLP principles of a test facility is ascertained by inspections carried out by public officers following a detailed procedure which will eventually result in the above acknowledgement provided that no major deviations in the laboratory performance are detected.(ABSTRACT TRUNCATED AT 250 WORDS)

  15. The National Shipbuilding Research Program. Environmental Training Modules Module 1 - Good Environmental Practices

    DTIC Science & Technology

    1999-05-01

    industrial activities as well as facilities treating domestic wastewater. NPDES permits usually contain limits on the quantities of specific pollutants...herbicides, rodenticides, fungicides, nematicides, acaricides , as well as disinfectants, fumigants, and plant growth regulators. FIFRA requires...pesticide manufacturers to register all active ingredients of pesticide formulations. Many types of antifoulant coatings applied to the underwater hulls of

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

    ERIC Educational Resources Information Center

    Gassner, Michael

    2002-01-01

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

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

    PubMed

    2008-01-01

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

  18. Silica dust control in small-scale building/structure demolition operations using good work practice guidance

    NASA Astrophysics Data System (ADS)

    Muianga, C. V.; Rice, C. H.; Succop, P.

    2009-02-01

    Work practices can influence exposure, especially in small-scale operations conducted by mobile work crews. This study evaluated the use of information on good work practice in control guidance sheets adapted from UK Silica Essentials guidance sheets by trained workers and supervisors employed in small-scale concrete and masonry demolition operations. A one-page employee silica task-based control guidance sheet for each of four demolition tasks and multiple-page silica control guidance for supervisors were developed. Interactive, hands-on worker training on these task-based good work practice controls was developed. Training was presented to 26 participants from two demolition crews. Feedback on the training and task-based good work practice control guidance sheets was elicited. Observations of work practices were made before and after training. Participants indicated gains in knowledge and checklists were used to document skill attainment. The quality of the training and usefulness of the material/skills was rated high by trainees. Increased use of water to suppress dust and wet cleaning methods on the job were documented following the training. Additional follow-up after training is required to determine long-term impact on sustained changes in work practices, and to evaluate the need for refresher training.

  19. BMP Report Of Survey Conducted At University Of New Orleans, LA Best Manufacturing Practices

    DTIC Science & Technology

    2003-01-01

    Management Continuous Improvement of Drydocking Management.................................... 19 Six Sigma and Lean Manufacturing in Shipbuilding...Six Sigma and Lean Manufacturing in Shipbuilding The University of New Orleans, College of Engi- neering is sponsoring a Six Sigma and Lean Manu...Technology Appli- cation Center has begun a project to incorporate the principles of Six Sigma and Lean Manufacturing within the shipbuilding industry

  20. Best Manufacturing Practices: Report of Survey Conducted at UNISYS corporation Computer Systems Division, St. Paul, Minnesota

    DTIC Science & Technology

    1987-11-01

    test sequence. Just In Time Manufacturing Just In Time (JIT) manufacturing has been implemented at the UNISYS CSD site in Pueblo, CO. The Pueblo...inspection, staging, and distribution is performed in a highly automated "paperless" environment. Additionally, Just In Time manufacturing concepts have

  1. Clinical audit of leg ulceration prevalence in a community area: a case study of good practice.

    PubMed

    Hindley, Jenny

    2014-09-01

    This article presents the findings of an audit on venous leg ulceration prevalence in a community area as a framework for discussing the concept and importance of audit as a tool to inform practice and as a means to benchmark care against national or international standards. It is hoped that the discussed audit will practically demonstrate how such procedures can be implemented in practice for those who have not yet undertaken it, as well as highlighting the unexpected extra benefits of this type of qualitative data collection that can often unexpectedly inform practice and influence change. Audit can be used to measure, monitor and disseminate evidence-based practice across community localities, facilitating the identification of learning needs and the instigation of clinical change, thereby prioritising patient needs by ensuring safety through the benchmarking of clinical practice.

  2. Life‐cycle and cost of goods assessment of fed‐batch and perfusion‐based manufacturing processes for mAbs

    PubMed Central

    Bunnak, Phumthep; Allmendinger, Richard; Ramasamy, Sri V.; Lettieri, Paola

    2016-01-01

    Life‐cycle assessment (LCA) is an environmental assessment tool that quantifies the environmental impact associated with a product or a process (e.g., water consumption, energy requirements, and solid waste generation). While LCA is a standard approach in many commercial industries, its application has not been exploited widely in the bioprocessing sector. To contribute toward the design of more cost‐efficient, robust and environmentally‐friendly manufacturing process for monoclonal antibodies (mAbs), a framework consisting of an LCA and economic analysis combined with a sensitivity analysis of manufacturing process parameters and a production scale‐up study is presented. The efficiency of the framework is demonstrated using a comparative study of the two most commonly used upstream configurations for mAb manufacture, namely fed‐batch (FB) and perfusion‐based processes. Results obtained by the framework are presented using a range of visualization tools, and indicate that a standard perfusion process (with a pooling duration of 4 days) has similar cost of goods than a FB process but a larger environmental footprint because it consumed 35% more water, demanded 17% more energy, and emitted 17% more CO2 than the FB process. Water consumption was the most important impact category, especially when scaling‐up the processes, as energy was required to produce process water and water‐for‐injection, while CO2 was emitted from energy generation. The sensitivity analysis revealed that the perfusion process can be made more environmentally‐friendly than the FB process if the pooling duration is extended to 8 days. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1324–1335, 2016 PMID:27390260

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

    ERIC Educational Resources Information Center

    Johnson, Sherryl

    2014-01-01

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

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

    ERIC Educational Resources Information Center

    Dunworth, Katie

    2008-01-01

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

  5. HIV & AIDS and Educator Development, Conduct and Support. Good Policy and Practice in HIV & AIDS and Education. Booklet 3

    ERIC Educational Resources Information Center

    Attawell, Kathy; Elder, Katharine

    2006-01-01

    Although there is a need for enhanced evidence-based information on successful HIV and AIDS education interventions, much has already been learnt about good practices and policies in the education sector's response to the pandemic. This booklet, to be used in tandem with others in the series, aims to further expand our knowledge by highlighting…

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

    ERIC Educational Resources Information Center

    Grunberg, Laura

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

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

    ERIC Educational Resources Information Center

    Mahieu, Paul; Clycq, Noel

    2007-01-01

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

  8. Are exposure index values consistent in clinical practice? A multi-manufacturer investigation.

    PubMed

    Butler, M L; Rainford, L; Last, J; Brennan, P C

    2010-01-01

    The advent of digital radiography poses the risk of unnoticed increases in patient dose. Manufacturers have responded to this by offering an exposure index (EI) value to the clinician. Whilst the EI value is a measure of the air kerma at the detector surface, it has been recommended by international agencies as a method of monitoring radiation dose to the patient. Recent studies by the group have shown that EI values are being used in clinical practice to monitor radiation dose and assess image quality. This study aims to compare the clinical consistency of the EI value in computed radiography (CR) and direct digital radiography (DR) systems. An anthropormorphic phantom was used to simulate four common radiographic examinations: skull, pelvis, chest and hand. These examinations were chosen as they provide contrasting exposure parameters, image detail and radiation dose measurements. Four manufacturers were used for comparison: Agfa Gaevert CR, Carestream CR, Philips Digital Diagnost DR and Siemens DR. For each examination, the phantom was placed in the optimal position and exposure parameters were chosen in accordance with European guidelines and clinical practice. Multiple exposures were taken and the EI recorded. All exposure parameters and clinical conditions remained constant throughout. For both DR systems, the EI values remained consistent throughout. No significant change was noted in any examination. In both CR systems, there were noteworthy fluctuations in the EI values for all examinations. The largest for the Agfa system was a variation of 1.88-2.21 for the skull examination. This represents to the clinician a doubling of detector dose, despite all exposure parameters remaining constant. In the Kodak system, the largest fluctuation was seen for the chest examination where the EI ranged from 2560 to 2660, representing approximately an increase of 30 % in radiation dose, despite consistent parameters. The fluctuations seen with the CR systems are most

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

    ERIC Educational Resources Information Center

    Devine, Dympna; Fahie, Declan; McGillicuddy, Deirdre

    2013-01-01

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

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

    PubMed Central

    2011-01-01

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

  11. Guideline to good practices for seasonal facility preservation at DOE nuclear facilities

    SciTech Connect

    Not Available

    1994-06-01

    This guide is intended to assist facility maintenance organizations in the review of existing methods and in the development of new methods for establishing a maintenance Seasonal Facility Preservation program. It is expected that each DOE facility may use approaches or methods different from those defined in this guide. The specific guidelines that follow reflect generally accepted industry practices. Therefore, deviation from any particular guideline would not, in itself, indicate a problem. If substantive differences exist between the intent of this guideline and actual practice, management should evaluate current practice to determine the need to include/exclude proposed features. A change in maintenance practice would be appropriate if a performance weakness were determined to exist. The development, documentation, and implementation of other features that further enhance these guidelines for specific applications are encouraged.

  12. Best Manufacturing Practices Survey Conducted at Texas Instruments, Defense Systems and Electronics Group, Lewisville, Texas

    DTIC Science & Technology

    1986-05-01

    government non-acceptance of digitized data as "master" drawings, government furnished equipment impact on just - in - time manufacturing , and insufficient...of this concept were observed. TI personnel indicated that the systems were accurate and reliable. JUST - IN - TIME MANUFACTURING One of the most... in - time manufacturing have been imple- mented in several areas. TI has removed the human error factor and instituted complete automation of operations

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

    ERIC Educational Resources Information Center

    Goodman, Kathleen M.

    2014-01-01

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

  14. Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals

    PubMed Central

    Elsinga, Philip; Todde, Sergio; Penuelas, Ivan; Meyer, Geerd; Farstad, Brit; Faivre-Chauvet, Alain; Mikolajczak, Renata; Westera, Gerrit; Gmeiner-Stopar, Tanja

    2010-01-01

    This guidance is meant as a guidance to Part B of the EANM “Guidelines on Good Radiopharmacy Practice (GRPP)” issued by the Radiopharmacy Committee of the EANM (see www.eanm.org), covering the small-scale “in house” preparation of radiopharmaceuticals which are not kit procedures. The aim is to provide more detailed and practice-oriented guidance to those who are involved in the small-scale preparation of, for example, PET, therapeutic or other radiopharmaceuticals which are not intended for commercial purposes or distribution. PMID:20306035

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

    ERIC Educational Resources Information Center

    Bouffard, Marcel; Reid, Greg

    2012-01-01

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

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

    ERIC Educational Resources Information Center

    Chizmar, John F.; Walbert, Mark S.

    1999-01-01

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

  17. How Supplemental Instruction Stacks Up Against Chickering's 7 Principles for Good Practice in Undergraduate Education.

    ERIC Educational Resources Information Center

    Congos, Dennis H.

    2002-01-01

    Argues for the academic performance and retention benefits of Supplemental Instruction (SI). Among other things, SI increases retention, increases final course grade averages, increases overall GPAs, improves thinking and study skills, and increases graduation rates. Compares a list of Chickering's 7 Principles to the practices of SI programs.…

  18. Good Students beat the computer system: Strategies for self learning from computerized practice in arithmetic

    NASA Astrophysics Data System (ADS)

    Hativa, Nira

    1992-02-01

    Naturalistic methods of inquiry were used to investigate learning processes of above-average second, third, and fourth graders while practicing arithmetic with a computer. Because the software enabled the better students to accelerate through the practice material, they received practice in topics that had not yet been covered in class, and thus were attempting material which was new to them. It also happened that they encountered exercises that they had learned in class but had forgotten how to solve. This study reveals that when confronted by exercises they do not know how to solve, above average students use a variety of strategies that lead to their identification of solution algorithms, while not always understanding the underlying concepts. The article identifies the different problem solving strategies that students used, sorts them into categories, and illustrates them with examples from students' protocols. On the basis of the findings, suggestions are made for designing computer software for arithmetic practice that promotes student problem solving strategies along with mathematical understanding.

  19. Good Students Beat the Computer System: Strategies for Self Learning from Computerized Practice in Arithmetic.

    ERIC Educational Resources Information Center

    Hativa, Nira

    1992-01-01

    Examined the problem-solving strategies of above average students (n=42) in grades 2-4 on problems involving forgotten or new material while practicing arithmetic with a computer. Identified the different problem-solving strategies used, sorted them into categories, and illustrated them with examples from students' protocols. Made suggestions for…

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

    ERIC Educational Resources Information Center

    Kortegast, Carrie A.; Boisfontaine, M. Terral

    2015-01-01

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

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

    ERIC Educational Resources Information Center

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

    2006-01-01

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

  2. Guideline to good practices for facility condition inspections at DOE nuclear facilities

    SciTech Connect

    Not Available

    1994-06-01

    This guide is intended to provide a means for owner/operators to have an awareness of the way business is actually being conducted on the shop floor. Also, this guide is intended to provide a means for maintenance managers to impart their expectations to crafts persons as to how maintenance should be conducted. It is expected that each DOE facility may use different approaches or methods than those defined in this guide. Explanation of the intent of this guide is provided in the Discussion section, and the specific guidelines that follow reflect generally accepted industry practices. In some cases, example situations accompany these guidelines. These examples have been provided only as an aid in clear understanding of the guidelines and should not be construed as the only method for meeting the intent of the guidelines. Therefore, deviation from any particular guideline would not, in itself, indicate a problem. If substantive differences exist between the intent of the Guideline and actual practice, management should evaluate current practice to determine the need to include/exclude proposed features. A change to maintenance practice would be appropriate if a performance weakness was determined to exist. Development, documentation, and implementation of other features which further enhance these guidelines for specific applications, is encouraged.

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

    ERIC Educational Resources Information Center

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

    2005-01-01

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

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

    ERIC Educational Resources Information Center

    Baker, Anthony; Beames, Stephanie

    2016-01-01

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

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

    ERIC Educational Resources Information Center

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

    2009-01-01

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

  6. The Geography Discipline Network Guides to Good Teaching, Learning and Assessment Practice: A Southern African Perspective.

    ERIC Educational Resources Information Center

    Nel, Etienne

    1999-01-01

    Reviews the series of books, "The Geography Discipline Network Guides on Teaching, Learning, and Assessment," produced by the Geography Discipline Network. Reveals two strengths of the series: (1) it provides practical guidelines on improving traditional teaching strategies; and (2) it promotes active learning. Considers the potential…

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

    NASA Astrophysics Data System (ADS)

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

    2016-04-01

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

  8. A Guide to Providing Social Support for Apprentices. Good Practice Guide

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2016

    2016-01-01

    The main purpose of this guide is to provide some ideas for employers of apprentices to provide an environment in which strong informal bases of support can succeed. Formal mentoring is an important aspect of apprenticeships; however, it is also informal mentoring--practices that are difficult to formally nurture--that plays a significant and…

  9. Freeze drying--principles and practice for successful scale-up to manufacturing.

    PubMed

    Tsinontides, S C; Rajniak, P; Pham, D; Hunke, W A; Placek, J; Reynolds, S D

    2004-08-06

    Freeze Drying involves transfer of heat and mass to and from the product under preparation, respectively, thus it is necessary to scale these transport phenomena appropriately from pilot plant to manufacturing-scale units to maintain product quality attributes. In this manuscript we describe the principal approach and tools utilized to successfully transfer the lyophilization process of a labile pharmaceutical product from pilot plant to manufacturing. Based on pilot plant data, the lyophilization cycle was tested during limited scale-up trials in manufacturing to identify parameter set-point values and test process parameter ranges. The limited data from manufacturing were then used in a single-vial mathematical model to determine manufacturing lyophilizer heat transfer coefficients, and subsequently evaluate the cycle robustness at scale-up operating conditions. The lyophilization cycle was then successfully demonstrated at target parameter set-point values.

  10. Circular economy practices among Chinese manufacturers varying in environmental-oriented supply chain cooperation and the performance implications.

    PubMed

    Zhu, Qinghua; Geng, Yong; Lai, Kee-hung

    2010-06-01

    The rapidly growing industrial activities in emerging economies such as China have been causing resource depletion and pollution problems. This reality requires China to adopt an integrated management approach to resolve the conflict between industrial development and environmental protection, and the concept of circular economy (CE) serves this purpose. In this paper, we examine if different types of manufacturing enterprises on environmental-oriented supply chain cooperation (ESCC) exist. We also determine if the Chinese manufacturer types varying in ESCC differ in their implementation of the CE practices towards achieving the CE-targeted goals on improving both environmental and economic performance. Our cluster analytic results with multivariate analysis of variance (MANOVA) among the four identified types of Chinese manufacturers varying in environmental-oriented supply chain cooperation highlight the importance to intensify the cooperation with upstream and downstream supply chain partners for a CE initiative to succeed.

  11. Long-term effects of good handling practices during the pre-weaning period of crossbred dairy heifer calves.

    PubMed

    Silva, Luciana Pontes; Sant'Anna, Aline Cristina; Silva, Lívia Carolina Magalhães; Paranhos da Costa, Mateus José Rodrigues

    2017-01-01

    The aim of this study was to determine whether applying good practices of handling during the pre-weaning period have long-term effects on behavioral and physiological indicators, health status, and average daily gain (ADG) of crossbred Bos taurus × Bos indicus heifer calves. During the pre-weaning period, 98 crossbred of Holstein × Gir heifer calves were allotted into three treatments: (1) good practices of handling + brushing (GPB; n = 25), (2) good practices of handling (GP; n = 25), and (3) control (n = 48). Every 2 months, four evaluation periods (EV1 to EV4) were conducted to record data. Behavioral indicators comprised time to drive (TD), flight speed (FS), flight distance (FD), and composite reactivity score (CRS). Physiological indicators of acute stress during handling comprised respiratory and heart rates. Health status comprised data regarding occurrence of most common diseases (i.e., pneumonia and anaplasmosis). Collected data were analyzed by using a linear mixed model for repeated measures, Tukey's test, and chi-squared procedures. Treatment influenced (P < 0.05) TD, FS, and FD but not CRS (P = 0.78). From EV1 to EV3, the control calves had the lowest TD. The GPB group had lower FS than the control but did not differ from GP. The GPB group had lower FD means than the other two groups in EV2, EV3, and EV4. No differences (P > 0.05) due to treatment were observed on heart and respiratory rates, ADG, or occurrence of pneumonia and anaplasmosis. It was concluded that adoption of good practices of handling during pre-weaning period may lead to long-term positive effects.

  12. Experiences of 24-hour advice line services: a framework for good practice and meeting NICE guidelines.

    PubMed

    Yardley, Sarah J; Codling, Jan; Roberts, Dai; O Donnell, Valerie; Taylor, Sue

    2009-06-01

    This article presents a framework for the practical implementation of a 24-hour specialist palliative care advice line, illustrated by two case examples from the authors' experience. In the UK, National Institute for Health and Clinical Excellence guidance requires provision of 24-hour access to specialist palliative care advice for healthcare professionals and carers regardless of a patient's location. Effective implementation of a telephone advice line for specialist advice is one approach to addressing the current variability in palliative care service provision, both in the UK and elsewhere. The authors were unable to identify a model with documentation for ensuring adequate clinical governance of an advice line in the literature and so present their own. The accompanying case examples demonstrate the difference between 'evolution of services by demand' and taking a systemic approach to service design. Key recommendations for practice are outlined for an effective advice line service which incorporates training and education into the clinical governance structures of the host organization.

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

    PubMed

    Lauder, W; Anderson, I; Barclay, A

    2005-04-01

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

  14. [Value of a good example: a search for role models in practical clinical teaching].

    PubMed

    Stegeman, J H

    2001-03-03

    The importance of the role model function of the 'teacher' (m/f) was always realized to some extent in practical clinical teaching, but appears to be gaining renewed interest at present. There exists, however, a discrepancy between the importance attached by many experienced clinicians and their students to the role model on the one hand, and the amount of systematical study that has been dedicated to it on the other hand. The available date show an impressionistic image of the qualities these students and interns consider important in role models. However, the 'why' of the importance of role models is seldom considered. In an era in which it is considered important that 'learning targets', 'learning moments' and 'transfer mechanisms' are defined in detail, the function of role models in practical clinical teaching should also be given more attention. Insights from other fields of knowledge than the medical field might be of value in designing research leading to a clearer image of the function and the value of role models in practical clinical education.

  15. Rules of good practice in the care of laboratory animals used in biomedical research.

    PubMed

    Valanzano, Angelina

    2004-01-01

    In recent years, the use of laboratory animals has decreased as a result of the adoption of alternative methods such as in vitro experiments and simulation studies. Nonetheless, animal models continue to be necessary in many fields of biomedical research, giving rise to ethical issues regarding the treatment of these animals. In the present work, a general overview of the rules of good practise in caring for laboratory animals is provided, focussing on housing conditions and the proper means of handling animals, including the importance of the relationship or "bond" between the researcher and the animal.

  16. Promoting good clinical laboratory practices and laboratory accreditation to support clinical trials in sub-Saharan Africa.

    PubMed

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

    2012-04-01

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

  17. [Manual for the design of non-drug trials in primary care, taking account of Good Clinical Practice (GCP) criteria].

    PubMed

    Joos, Stefanie; Bleidorn, Jutta; Haasenritter, Jörg; Hummers-Pradier, Eva; Peters-Klimm, Frank; Gágyor, Ildikó

    2013-01-01

    In recent years studies not falling under the German Pharmaceutical Law ("non-drug trials") have also been increasingly expected to be conducted according to Good Clinical Practice (GCP) in order to ensure that uniform standards are maintained for data quality and patient safety. However, simple transfer of the GCP criteria is not always possible and often not useful. Given the fact that research questions regarding non-drug interventions are common in primary care (e.g., general practice), the "Network for Clinical Studies in General Practice" has developed a manual for planning and conducting non-drug trials. This manual is based on the GCP guideline, taking account of the conditions and circumstances in primary care settings. Both structure and relevant content of the manual are presented in the article. (As supplied by the authors).

  18. Financial Incentives to Enable Clean Energy Deployment: Policy Overview and Good Practices

    SciTech Connect

    Cox, Sadie

    2016-02-24

    Financial incentives have been widely implemented by governments around the world to support scaled up deployment of renewable energy and energy efficiency technologies and practices. As of 2015, at least 48 countries have adopted financial incentives to support renewable energy and energy efficiency deployment. Broader clean energy strategies and plans provide a crucial foundation for financial incentives that often complement regulatory policies such as renewable energy targets, standards, and other mandates. This policy brief provides a primer on key financial incentive design elements, lessons from different country experiences, and curated support resources for more detailed and country-specific financial incentive design information.

  19. The lactic acid bacteria and yeast microbiota of eighteen sourdoughs used for the manufacture of traditional Italian sweet leavened baked goods.

    PubMed

    Lattanzi, Anna; Minervini, Fabio; Di Cagno, Raffaella; Diviccaro, Annamaria; Antonielli, Livio; Cardinali, Gianluigi; Cappelle, Stefan; De Angelis, Maria; Gobbetti, Marco

    2013-05-15

    The lactic acid bacteria and yeast microbiota of eighteen sourdoughs used for the manufacture of some traditional Italian sweet leavened baked goods were studied through culture-dependent method and pyrosequencing. Flours used for back slopping and sourdoughs were also biochemically characterized. Principal component analysis was applied to explore eventual correlations between process parameters applied during back slopping, some flour nutrients, profile of microbiota, and biochemical characteristics of sourdoughs. The median values of the cell density of lactic acid bacteria and yeasts were 8.05 and 7.03 log CFU/g, respectively. As shown by culture-dependent method, Lactobacillus sanfranciscensis was identified in all the sourdoughs, except for Panaredda and Torcolo di San Costanzo. For eleven sourdoughs, all the lactic acid bacteria isolates were allotted to this species. For Buccellato di Lucca, Mbriagotto, Pandoro, and Nadalin sourdoughs, at least 80% of the isolates was allotted to this species. Other lactic acid bacteria isolated with a relatively high frequence were Lactobacillus plantarum and Leuconostoc citreum. Pyrosequencing confirmed and complemented the culture-dependent approach, detecting L. sanfranciscensis also in Panaredda and Torcolo di San Costanzo sourdoughs. Saccharomyces cerevisiae was identified in all the sourdoughs, except for Mbriagotto, Ciambella di Mosto and Pandolce Genovese. These latter sourdoughs harbored strains of Candida humilis, whereas five sourdoughs combined the presence of both yeast species. Positive correlations were found between time of back slopping and cell density and main metabolites of lactic acid bacteria. Percentage of sourdough used as inoculum was mainly correlated with the cell density of yeasts and the concentration of ethanol. This study provided a comprehensive and comparative approach to highlight the dominant microbiota of Italian sourdoughs, which could be exploited further to guarantee a highly

  20. 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

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

    PubMed

    Kogi, K

    2006-01-01

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

  2. Best Practices: DOD Can Achieve Better Outcomes by Standardizing the Way Manufacturing Risks are Managed

    DTIC Science & Technology

    2010-04-01

    turbine airfoil shaped-hole manufacturing. The turbine airfoil is a part of the jet engine that generates power—it extracts horsepower from the high...Advanced Scintillator Material 28 Figure 5: Honeywell Uses Three Producibility Models and MRL Workshop 30 Figure 6: GE Aviation’s Turbine Airfoils Lean...essential to find better ways of doing business and, in particular, to make sure systems are manufactured on time and cost-effectively. To this end, leading

  3. Field Evaluation of Advances in Energy-Efficiency Practices for Manufactured Homes

    SciTech Connect

    E. Levy; Dentz, J.; Ansanelli, E.; Barker, G.; Rath, P.; Dadia, D.

    2016-03-01

    Through field-testing and analysis, this project evaluated whole-building approaches and estimated the relative contributions of select technologies toward reducing energy use related to space conditioning in new manufactured homes. Three lab houses of varying designs were built and tested side-by-side under controlled conditions in Russellville, Alabama. The tests provided a valuable indicator of how changes in the construction of manufactured homes can contribute to significant reductions in energy use.

  4. 78 FR 3646 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-16

    ..., closures, and in-process material; production and process controls; and records and reports for LACF. Part 114 establishes requirements for production and process controls and records and reports for acidified... requirements such as for the use of written procedures for certain operations; a production and process...

  5. 78 FR 48636 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ... collection: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Drive, PI50-400T, Rockville, MD 20850, domini.bean@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background...

  6. 78 FR 22887 - Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-17

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A... announcing the availability of a guidance for industry entitled ``Non-Penicillin Beta- Lactam Drugs: A CGMP... (APIs) with non-penicillin beta-lactams. This guidance also provides information regarding the...

  7. [Evaluation of good manufacturing practices in the elaboration of enteral formulas in public hospitals of Santiago (Chile)].

    PubMed

    Lara González, Sandra; Domecq Jendres, C; Atalah Samur, Eduardo

    2013-11-01

    Antecedentes: La Elaboración de fórmulas enterales está sujeta a diversos riesgos de contaminación. La Organización Mundial de la Salud (OMS) y la Organización para la Alimentación y la Agricultura (FAO) han emitido alertas y recomendaciones para su prevención, sugiriendo la estandarización y protocolización de todos los procedimientos involucrados. Objetivo: Elaborar y evaluar el cumplimiento de los criterios técnicos de una Pauta de Verificación de Buenas Prácticas de Manufactura, con relación a elaboración, conservación y administración de fórmulas enterales en hospitales de la provincia de Santiago. Material y métodos: Los criterios de verificación consideraron Planta Física, Equipamiento e Implementación, Normas Higiénicas y Sanitarias, Recurso Humano, Organización y Administración, Garantía de Inocuidad y Aseguramiento de la Calidad. Se definieron 639 criterios, 309 de Riesgo Tipo 1, por mayor riesgo de producir contaminación. El estudio se hizo por observación de las Unidades de Central de Fórmulas Enterales y entrevista con el profesional encargado. Se analizó la mediana de cumplimiento de cada grupo de criterios de riesgo tipo 1 y total. Resultados: Se evaluaron públicos 14 hospitales. El grado de cumplimiento de los 639 alcanzó una mediana de 33,2% (p25-75 31,6% -40,4%), con el valor más bajo para planta física con 27,9% (p25-75 23,9% -38,2%) y el mayor para recurso humano con 52,4% (p25-75 44,1%-52,4%). La mediana de grado de cumplimiento para Criterios Riesgo Tipo 1, fue sólo de 31,8% (p25-75 27,5% - 41,2%). Conclusión: La mayoría de las Unidades evaluadas, cumple con menos de la mitad de las recomendaciones internacionales o del Ministerio de Salud de Chile. Se deben elaborar protocolos y capacitar al personal para asegurar la calidad e inocuidad en la elaboración de fórmulas enterales y reducir los riesgos de infección.

  8. 78 FR 17142 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-20

    ... and it can get into food by a variety of mechanisms (see section II.D of the preamble of this document... (including food-contact surfaces) and to food. Transfer can occur by people (e.g., if a person touches the... escape a dry cleaning process. When these locations get wet, the Salmonella spp. grows and...

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

    PubMed Central

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

    2015-01-01

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

  10. Defining principles for good practice: using case studies to inform health systems action on health inequalities.

    PubMed

    Simpson, Sarah; Kelly, Michael P; Morgan, Antony

    2013-02-01

    This paper presents work using case studies as a source of data to see if we could extrapolate from the specific to the general particularly with regard to understanding what constitutes effective practice in taking action on SDHI and as a way of enabling policy makers to make better use of knowledge within the case studies and as a way of better understanding what works, in what context and why. Case studies are important to evaluators in that they are relatively straightforward to undertake and because those involved in implementing an intervention are usually keen to profile the intervention. A checklist described in this paper will enable policy advisers and evaluators to quickly review a case study and right away see if it contains enough information to assist in the development of policy options for reducing socially determined health inequalities.

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

    PubMed Central

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

    2015-01-01

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

  12. Practical considerations for conducting ecotoxicity test methods with manufactured nanomaterials: what have we learnt so far?

    PubMed

    Handy, Richard D; van den Brink, Nico; Chappell, Mark; Mühling, Martin; Behra, Renata; Dušinská, Maria; Simpson, Peter; Ahtiainen, Jukka; Jha, Awadhesh N; Seiter, Jennifer; Bednar, Anthony; Kennedy, Alan; Fernandes, Teresa F; Riediker, Michael

    2012-05-01

    This review paper reports the consensus of a technical workshop hosted by the European network, NanoImpactNet (NIN). The workshop aimed to review the collective experience of working at the bench with manufactured nanomaterials (MNMs), and to recommend modifications to existing experimental methods and OECD protocols. Current procedures for cleaning glassware are appropriate for most MNMs, although interference with electrodes may occur. Maintaining exposure is more difficult with MNMs compared to conventional chemicals. A metal salt control is recommended for experiments with metallic MNMs that may release free metal ions. Dispersing agents should be avoided, but if they must be used, then natural or synthetic dispersing agents are possible, and dispersion controls essential. Time constraints and technology gaps indicate that full characterisation of test media during ecotoxicity tests is currently not practical. Details of electron microscopy, dark-field microscopy, a range of spectroscopic methods (EDX, XRD, XANES, EXAFS), light scattering techniques (DLS, SLS) and chromatography are discussed. The development of user-friendly software to predict particle behaviour in test media according to DLVO theory is in progress, and simple optical methods are available to estimate the settling behaviour of suspensions during experiments. However, for soil matrices such simple approaches may not be applicable. Alternatively, a Critical Body Residue approach may be taken in which body concentrations in organisms are related to effects, and toxicity thresholds derived. For microbial assays, the cell wall is a formidable barrier to MNMs and end points that rely on the test substance penetrating the cell may be insensitive. Instead assays based on the cell envelope should be developed for MNMs. In algal growth tests, the abiotic factors that promote particle aggregation in the media (e.g. ionic strength) are also important in providing nutrients, and manipulation of the media

  13. Good Medical Practice for Drugs. Definition, Guidelines, References, Field of Action and Applications.

    PubMed

    Bergmann, Jean-François

    2008-01-01

    Proper use of drugs can be defined as the use of the right product, in a correct dosage, during an adequate length of time, for a given patient and provided he has no serious side effects. It is virtually impossible, with such a number of drugs, such a number of clinical situations to prescribe adequately without using references or guidelines. References may lead to a unique choice, when the diagnosis is certain and the drug to be given is unique. With a good initial and continuous medical education, doctors can take easily this type of decision. The Summary of Products Characteristics (SPC) helps them; by sticking to this fundamental reference, prescription might be more precise and safe. In a lot of clinical situations the choice between a large numbers of therapeutic strategies necessitates use of a guideline based on scientific knowledge. Finally, a given therapeutic strategy can be as effective as and considerably less expensive than another. In such cases, payers can drive doctors to the prescription of the less expensive strategy. Some difficulties are common to all references and guidelines.

  14. Barriers and enablers to good communication and information-sharing practices in care planning for chronic condition management.

    PubMed

    Lawn, Sharon; Delany, Toni; Sweet, Linda; Battersby, Malcolm; Skinner, Timothy

    2015-01-01

    Our aim was to document current communication and information-sharing practices and to identify the barriers and enablers to good practices within the context of care planning for chronic condition management. Further aims were to make recommendations about how changes to policy and practice can improve communication and information sharing in primary health care. A mixed-method approach was applied to seek the perspectives of patients and primary health-care workers across Australia. Data was collected via interviews, focus groups, non-participant observations and a national survey. Data analysis was performed using a mix of thematic, discourse and statistical approaches. Central barriers to effective communication and information sharing included fragmented communication, uncertainty around client and interagency consent, and the unacknowledged existence of overlapping care plans. To be most effective, communication and information sharing should be open, two-way and inclusive of all members of health-care teams. It must also only be undertaken with the appropriate participant consent, otherwise this has the potential to cause patients harm. Improvements in care planning as a communication and information-sharing tool may be achieved through practice initiatives that reflect the rhetoric of collaborative person-centred care, which is already supported through existing policy in Australia. General practitioners and other primary care providers should operationalise care planning, and the expectation of collaborative and effective communication of care that underpins it, within their practice with patients and all members of the care team. To assist in meeting these aims, we make several recommendations.

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

    PubMed

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

    2015-02-01

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

  16. Chlorophyll fluorescence analysis: a guide to good practice and understanding some new applications.

    PubMed

    Murchie, E H; Lawson, T

    2013-10-01

    Chlorophyll fluorescence is a non-invasive measurement of photosystem II (PSII) activity and is a commonly used technique in plant physiology. The sensitivity of PSII activity to abiotic and biotic factors has made this a key technique not only for understanding the photosynthetic mechanisms but also as a broader indicator of how plants respond to environmental change. This, along with low cost and ease of collecting data, has resulted in the appearance of a large array of instrument types for measurement and calculated parameters which can be bewildering for the new user. Moreover, its accessibility can lead to misuse and misinterpretation when the underlying photosynthetic processes are not fully appreciated. This review is timely because it sits at a point of renewed interest in chlorophyll fluorescence where fast measurements of photosynthetic performance are now required for crop improvement purposes. Here we help the researcher make choices in terms of protocols using the equipment and expertise available, especially for field measurements. We start with a basic overview of the principles of fluorescence analysis and provide advice on best practice for taking pulse amplitude-modulated measurements. We also discuss a number of emerging techniques for contemporary crop and ecology research, where we see continual development and application of analytical techniques to meet the new challenges that have arisen in recent years. We end the review by briefly discussing the emerging area of monitoring fluorescence, chlorophyll fluorescence imaging, field phenotyping, and remote sensing of crops for yield and biomass enhancement.

  17. The good, the bad and the 'not so bad': reflecting on moral appraisal in practice.

    PubMed

    Begley, Ann Marie

    2011-03-01

    The aim of this study is to facilitate reflection on the moral merit of practitioners in various contexts. Insight is gained from Aristotelian and Kantian accounts of moral character and an original framework for reflection is presented as an adjunct to ethical theory and principles considered when appraising others. In relation to states of character, there is an irreconcilable difference between Kantian (deontic) and Aristotelian (aretaic) conceptions of the nature of full virtue (excellence of character), but at the same time it can be argued that in relation to practice their approaches complement each other. It is also argued that in relation to caring for the vulnerable, Aristotle's conception of full virtue is more compelling than Kant's. On the other hand, Kant's notion of self-serving action is important in nursing and it therefore needs to be considered when reflecting on professional conduct. The conclusion reached is that Aristotelian and Kantian accounts of character appraisal should be used in a combined approach to moral appraisal. This approach draws on the accounts of both philosophers and offers valuable insight into moral character, professional conduct and, in a more formal setting, fitness to practise.

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

    PubMed

    Lomas, Johnathan

    2003-01-01

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

  19. 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

  20. Good practice recommendations for outpatient parenteral antimicrobial therapy (OPAT) in adults in the UK: a consensus statement.

    PubMed

    Chapman, Ann L N; Seaton, R Andrew; Cooper, Mike A; Hedderwick, Sara; Goodall, Vicky; Reed, Corienne; Sanderson, Frances; Nathwani, Dilip

    2012-05-01

    These good practice recommendations for outpatient parenteral antimicrobial therapy (OPAT) are an update to a previous consensus statement on OPAT in the UK published in 1998. They are based on previous national and international guidelines, but have been further developed through an extensive consultation process, and are underpinned by evidence from published literature on OPAT. They provide pragmatic guidance on the development and delivery of OPAT services, looking at all aspects of service design, care delivery, outcome monitoring and quality assurance, with the aim of ensuring that OPAT services provide high-quality, low-risk care, whatever the healthcare setting. They will provide a useful resource for teams developing new services, as well as a practical set of quality indicators for existing services.

  1. LAMP Whys? LAMP Wise! A Practical Guide to the Lansing Area Manufacturing Partnership.

    ERIC Educational Resources Information Center

    MacAllum, Keith; McDonald, Deanne; Johnson, Amy Bell

    This document profiles the Lansing Area Manufacturing Partnership (LAMP), which is a model school-to-career initiative featuring an innovative integrated, employer-driven curriculum that was designed, developed, and implemented through the joint efforts of the Ingham Intermediate School District in Lansing, Michigan, the United Auto Workers (UAW),…

  2. Investigating inspection practices of pharmaceutical manufacturing facilities in selected Arab countries: views of inspectors and pharmaceutical industry employees.

    PubMed

    Garg, S; Hasan, R; Scahill, S; Babar, Z Ud-Din

    2013-11-01

    There are few studies that explore inspection practices of pharmaceutical facilities from the viewpoint of inspectors and industry employees. In this descriptive, cross-sectional study, inspectors and quality assurance staff from 4 Arab countries--the United Arab Emirates, Saudi Arabia, Egypt and Jordan--were surveyed about their inspection practices and views. There was considerable variation in inspection practices across countries and between the inspectorate and quality assurance staff within countries. Divergence was found in views associated with payment mechanisms. There was mutual agreement by both groups that inspectors were in short supply and that they needed to be better trained. Inspectors appeared to have less authority than expected in order to control pharmaceutical manufacturing and marketing activities. Compounding this was a dearth of policy which would support a more uniform and systematic approach to the inspection process within and across countries.

  3. Caught between the global economy and local bureaucracy: the barriers to good waste management practice in South Africa.

    PubMed

    Godfrey, Linda; Scott, Dianne; Trois, Cristina

    2013-03-01

    Empirical research shows that good waste management practice in South Africa is not always under the volitional control of those tasked with its implementation. While intention to act may exist, external factors, within the distal and proximal context, create barriers to waste behaviour. In addition, these barriers differ for respondents in municipalities, private industry and private waste companies. The main barriers to implementing good waste management practice experienced by respondents in municipalities included insufficient funding for waste management and resultant lack of resources; insufficient waste knowledge; political interference in decision-making; a slow decision-making process; lack of perceived authority to act by waste staff; and a low priority afforded to waste. Barriers experienced by respondents in private industry included insufficient funding for waste and the resultant lack of resources; insufficient waste knowledge; and government bureaucracy. Whereas, barriers experienced in private waste companies included increasing costs; government bureaucracy; global markets; and availability of waste for recycling. The results suggest that respondents in public and private waste organizations are subject to different structural forces that shape, enable and constrain waste behaviour.

  4. Utilization of the seven principles for good practice in undergraduate education in general chemistry by community college instructors

    NASA Astrophysics Data System (ADS)

    Panther Bishoff, Jennifer

    In recent years, higher education has undergone many changes. The advent of assessment, accountability, and a newfound focus on teaching have required faculty to examine how they are teaching. Administrators and faculty are beginning to recognize that learning is not a "one size fits all" enterprise. To this end, Chickering and Gamson developed an inventory that examined faculty utilization of the Seven Principles of Good Practice in Undergraduate Education. The seven principles included by the authors included faculty-student interaction, cooperative learning, active learning, giving prompt feedback, emphasizing time on task, communicating high expectations, and respecting diverse talents and ways of learning. It was determined by Chickering and Gamson, as well as many other researchers, that these seven principles were hallmarks of successful undergraduate education. Community colleges are important institutions to study, as many students begin their higher education at two-year colleges. Most students are also required to take one or more science classes for their general education requirements; therefore, many students must take at least one general chemistry course. Both community colleges and chemistry are rarely studied in literature, which makes this study important. Community college general chemistry instructors were surveyed using an online version of Chickering and Gamson's Faculty Inventory for the Seven Principles of Good Practice in Undergraduate Education. Responses were analyzed, and it was discovered that not only did instructors utilize the principles to a different extent, but there were also differences between genders as well as between the specific actions related to each principle.

  5. Promoting good clinical practices in the conduct of clinical trials: experiences in the Department of Veterans Affairs Cooperative Studies Program.

    PubMed

    Sather, Mike R; Raisch, Dennis W; Haakenson, Clair M; Buckelew, Julia M; Feussner, John R

    2003-10-01

    The ever-increasing concern for the welfare of volunteers participating in clinical trials and for the integrity of the data derived from those trials has generated the concept of Good Clinical Practice (GCP). The Veterans Affairs Cooperative Studies Program, in anticipation of the need to comply with GCP guidelines, developed a Site Monitoring and Review Team (SMART), which consists of a Good Clinical Practice Monitoring Group and a Good Clinical Practice Review Group. The review group conducted 335 site reviews from fiscal years (FY) 1999 through 2001 to assess and encourage adherence to GCP. Data from reviews were compared for two time periods, a 2-year implementation period (FYs 1999/2000, n=204) and a continuing follow-up period (FY 2001, n=131). Overall, high GCP adherence was exhibited by 11.3% (n=23) of study sites in FY 1999/2000 versus 20.6% (n=27) in FY 2001, average to good adherence was exhibited by 84.3% (n=172) in FY 1999/2000 versus 77.0% (n=101) in FY 2001, and below average adherence was exhibited by 4.4% (n=9) versus 1.5% (n=3) in these two periods. These changes were statistically significant by chi square analysis (p=0.029). Moreover, GCP adherence was assessed within eight GCP focus areas: patient informed consent, protocol adherence, safety monitoring, institutional review board interactions, regulatory document management, patient records in investigator file, drug/device accountability, and general site operations. Median assessment scores for all 62 GCP review elements improved from 0.82 to 0.89 (p<0.001). Median assessment scores for the 14 selected critical GCP items improved from 0.78 to 0.89 (p<0.001). Median scores for five of the eight GCP focus areas improved significantly (p<0.001) between the two time periods. These data suggest that the site-oriented activities of SMART combined with centralized quality assurance activities of the coordinating centers represent an integrated, versatile program to promote and assure GCP adherence

  6. Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

    PubMed

    Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

    2015-03-01

    This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation.

  7. Being a 'good mother': Dietary governmentality in the family food practices of three ethnocultural groups in Canada.

    PubMed

    Ristovski-Slijepcevic, Svetlana; Chapman, Gwen E; Beagan, Brenda L

    2010-09-01

    In this qualitative study with three ethnocultural groups in two regions of Canada, we explore how official dietary guidelines provide particular standards concerning 'healthy eating' that marginalize other understandings of the relationship between food and health. In families where parents and youth held shared ways of understanding healthy eating, the role of 'good mother' was constructed so as to include healthy eating expertise. Mothers expressed a perceived need to be personally responsible for providing skills and knowledge about healthy eating as well as guarding children against negative nutritional influences. Governing of family eating practices to conform to official nutritional advice occurred through information provision, monitoring in shopping and meal preparation, restricting and guiding food purchases, and directly translating expert knowledges into family food practices. In families where parents and youth held differing understandings of healthy eating, primarily families from ethnocultural minority groups, mothers often did not employ the particular western-originating strategies of conveying healthy eating information, or mentoring healthy meal preparation, nor did they regulate or restrict children's food consumption. Western dietary guidelines entered into the family primarily through the youth, emphasizing the nutritional properties of food, often devaluing 'traditional' knowledge about healthy eating. These processes exemplify techniques of governmentality which simultaneously exercise control over people's behaviour through normalizing some family food practices and marginalizing others.

  8. A Case Study of Institutional Visioning, Public Good, and the Renewal of Democracy: The Theory and Practice of Public Good Work at the University of Denver

    ERIC Educational Resources Information Center

    Fretz, Eric; Cutforth, Nick; Nicotera, Nicole; Thompson, Sheila Summers

    2009-01-01

    In 2001, the University of Denver included language in its vision statement that committed the institution to becoming "a great private university dedicated to the public good." This essay (1) explains how the development of an institutional visioning statement led to the implementation of a series of campus dialogues and action steps…

  9. Endorsing good quality assurance practices in molecular pathology: risks and recommendations for diagnostic laboratories and external quality assessment providers.

    PubMed

    Tembuyser, Lien; Dequeker, Elisabeth M C

    2016-01-01

    Quality assurance is an indispensable element in a molecular diagnostic laboratory. The ultimate goal is to warrant patient safety. Several risks that can compromise high quality procedures are at stake, from sample collection to the test performed by the laboratory, the reporting of test results to clinicians, and the organization of effective external quality assessment schemes. Quality assurance should therefore be safeguarded at each level and should imply a holistic multidisciplinary approach. This review aims to provide an overview of good quality assurance practices and discusses certain risks and recommendations to promote and improve quality assurance for both diagnostic laboratories and for external quality assessment providers. The number of molecular targets is continuously rising, and new technologies are evolving. As this poses challenges for clinical implementation and increases the demand for external quality assessment, the formation of an international association for improving quality assurance in molecular pathology is called for.

  10. [Good practice in occupational health services: prophylactic care and occupational activation of people with disabilities due to respiratory diseases].

    PubMed

    Wiszniewska, Marta; Tymoszuk, Diana; Lipińska-Ojrzanowska, Agnieszka; Wagrowska-Koski, Ewa; Walusiak-Skorupa, Jolanta

    2013-01-01

    Respiratory diseases are a cause of long-term sickness absence, and even of partial or complete inability to work. This paper presents the first in Poland description of principles of good practice in occupational health service provided for people with respiratory diseases. The issues concerning the certification of the ability to work in this group of patients are discussed. The key-principles of preventive care of workers with obstructive and interstitial lung diseases with particular attention paid to the control of major risk factors are also presented. The importance of possible contraindications for job performance by workers affected by these diseases, as well as the responsibilities of occupational health physicians were highlighted. M

  11. A practical and scalable manufacturing process for an anti-fungal agent, Nikkomycin Z.

    PubMed

    Stenland, Christopher J; Lis, Lev G; Schendel, Frederick J; Hahn, Nicholas J; Smart, Mary A; Miller, Amy L; von Keitz, Marc G; Gurvich, Vadim J

    2013-02-15

    A scalable and reliable manufacturing process for Nikkomycin Z HCl on a 170 g scale has been developed and optimized. The process is characterized by a 2.3 g/L fermentation yield, 79% purification yield, and >98% relative purity of the final product. This method is suitable for further scale up and cGMP production. The Streptomyces tendae ΔNikQ strain developed during the course of this study is superior to any previously reported strain in terms of higher yield and purity of Nikkomycin Z.

  12. A practical and scalable manufacturing process for an anti-fungal agent, Nikkomycin Z

    PubMed Central

    Stenland, Christopher J.; Lis, Lev G.; Schendel, Frederick J.; Hahn, Nicholas J.; Smart, Mary A.; Miller, Amy L.; von Keitz, Marc G.; Gurvich, Vadim J.

    2013-01-01

    A scalable and reliable manufacturing process for Nikkomycin Z HCl on a 170 g scale has been developed and optimized. The process is characterized by a 2.3 g/L fermentation yield, 79% purification yield, and >98% relative purity of the final product. This method is suitable for further scale up and cGMP production. The Streptomyces tendae ΔNikQ strain developed during the course of this study is superior to any previously reported strain in terms of higher yield and purity of Nikkomycin Z. PMID:23440664

  13. Using the reference framework for good measles management in practice--a case study from North Rhine-Westphalia.

    PubMed

    Schröter, Matthias; Schröder-Bäck, Peter; Brand, Helmut

    2009-12-01

    In 2005, WHO Europe reconfirmed the objective of eradicating measles and fixed a strategy plan for the years 2005 up to 2010. While a downward trend of measles infections in Germany between 2001 and 2004 could be observed, as many as 780 cases of measles were reported in 2005 and in 2006 even 2.281 cases. These high figures in 2006 were almost exclusively caused by an outbreak in the German region of North Rhine-Westphalia. This case study describes how a reference framework for good health management of measles prevention was applied for this region. As a result, various recommendations for action could be given, among them the recommendation to implement individual vaccination reminder systems for parents and bonus systems for parents. Based on these results, a comprehensive policy concept has been drawn up and has become the subject of a political agreement process in this region. Thus this case study shows a paradigm how reference frameworks for good health management can be utilised in practice.

  14. Practical application of game theory based production flow planning method in virtual manufacturing networks

    NASA Astrophysics Data System (ADS)

    Olender, M.; Krenczyk, D.

    2016-08-01

    Modern enterprises have to react quickly to dynamic changes in the market, due to changing customer requirements and expectations. One of the key area of production management, that must continuously evolve by searching for new methods and tools for increasing the efficiency of manufacturing systems is the area of production flow planning and control. These aspects are closely connected with the ability to implement the concept of Virtual Enterprises (VE) and Virtual Manufacturing Network (VMN) in which integrated infrastructure of flexible resources are created. In the proposed approach, the players role perform the objects associated with the objective functions, allowing to solve the multiobjective production flow planning problems based on the game theory, which is based on the theory of the strategic situation. For defined production system and production order models ways of solving the problem of production route planning in VMN on computational examples for different variants of production flow is presented. Possible decision strategy to use together with an analysis of calculation results is shown.

  15. Field Evaluation of Advances in Energy-Efficiency Practices for Manufactured Homes

    SciTech Connect

    Levy, E.; Dentz, J.; Ansanelli, E.; Barker, G.; Rath, P.; Dadia, D.

    2016-03-01

    Three side-by-side lab houses were built, instrumented and monitored in an effort to determine through field testing and analysis the relative contributions of select technologies toward reducing energy use in new manufactured homes. The lab houses in Russellville, Alabama compared the performance of three homes built to varying levels of thermal integrity and HVAC equipment: a baseline HUD-code home equipped with an electric furnace and a split system air conditioner; an ENERGY STAR manufactured home with an enhanced thermal envelope and traditional split system heat pump; and a house designed to qualify for Zero Energy Ready Home designation with a ductless mini-split heat pump with transfer fan distribution system in place of the traditional duct system for distribution. Experiments were conducted in the lab houses to evaluate impact on energy and comfort of interior door position, window blind position and transfer fan operation. The report describes results of tracer gas and co-heating tests and presents calculation of the heat pump coefficient of performance for both the traditional heat pump and the ductless mini-split. A series of calibrated energy models was developed based on measured data and run in three locations in the Southeast to compare annual energy usage of the three homes.

  16. The effects of forestry on Hg bioaccumulation in nemoral/boreal waters and recommendations for good silvicultural practice.

    PubMed

    Bishop, Kevin; Allan, Craig; Bringmark, Lage; Garcia, Edenise; Hellsten, Sofie; Högbom, Lars; Johansson, Kjell; Lomander, Anja; Meili, Markus; Munthe, John; Nilsson, Mats; Porvari, Petri; Skyllberg, Ulf; Sorensen, Rasmus; Zetterberg, Therese; Akerblom, Staffan

    2009-11-01

    Mercury (Hg) levels are alarmingly high in fish from lakes across Fennoscandia and northern North America. The few published studies on the ways in which silviculture practices influence this problem indicate that forest operations increase Hg in downstream aquatic ecosystems. From these studies, we estimate that between one-tenth and one-quarter of the Hg in the fish of high-latitude, managed forest landscapes can be attributed to harvesting. Forestry, however, did not create the elevated Hg levels in the soils, and waterborne Hg/MeHg concentrations downstream from harvested areas are similar to those from wetlands. Given the current understanding of the way in which silviculture impacts Hg cycling, most of the recommendations for good forest practice in Sweden appear to be appropriate for high-latitude regions, e.g., leaving riparian buffer zones, as well as reducing disturbance at stream crossings and in moist areas. The recommendation to restore wetlands and reduce drainage, however, will likely increase Hg/MeHg loadings to aquatic ecosystems.

  17. 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.

  18. A procedural framework for good imaging practice in pharmacological fMRI studies applied to drug development #2: protocol optimization and best practices.

    PubMed

    Schwarz, Adam J; Becerra, Lino; Upadhyay, Jaymin; Anderson, Julie; Baumgartner, Richard; Coimbra, Alexander; Evelhoch, Jeff; Hargreaves, Richard; Robertson, Brigitte; Iyengar, Smriti; Tauscher, Johannes; Bleakman, David; Borsook, David

    2011-08-01

    Functional magnetic resonance imaging (fMRI) experiments are more complex compared with standard radiological imaging, involving additional data streams and hardware along with complex analysis methods. Here, we propose guidelines based around mitigating risks associated with the complexities of the technique at the level of the individual imaging protocol, including workable and effective quality assurance/quality control procedures and rigorous, predefined, analysis pipelines. Our aim is to provide a framework for 'good imaging practice' (GIP), enabling these requirements to be addressed at an appropriate level of detail. The development of a procedural framework for GIP in pharmaceutical fMRI studies could lead to greater acceptance of the method within industry and facilitate validation and, eventually, qualification of the technique as an imaging biomarker.

  19. 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…

  20. 21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments,...