Good Laboratory Practice Standards
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Good Laboratory Practice Regulations
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Author : Allen F. Hirsch
language : en
Publisher: Marcel Dekker
Release Date : 1989
Good Laboratory Practice Regulations written by Allen F. Hirsch and has been published by Marcel Dekker this book supported file pdf, txt, epub, kindle and other format this book has been release on 1989 with Medical categories.
Good Laboratory Practice Standards
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Author : Willa Y. Garner
language : en
Publisher: Oxford University Press, USA
Release Date : 1992
Good Laboratory Practice Standards written by Willa Y. Garner and has been published by Oxford University Press, USA this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with Language Arts & Disciplines categories.
Written by experienced quality assurance (QA) professionals and field laboratory researchers. Provides concrete ideas for establishing a compliance program and refining the compliance process. Outlines approaches that have resulted in successful compliance and describes methods of avoiding some of the common mistakes. Appendices contain the entire GLP Enforcement Response Policy, a question-and-answer section, examples of forms for submitting data to the EPA, and the EPA's penalty policy.
Good Laboratory Practice Regulations Third Edition Revised And Expanded
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Author : Sandy Weinberg
language : en
Publisher: CRC Press
Release Date : 2002-11-06
Good Laboratory Practice Regulations Third Edition Revised And Expanded written by Sandy Weinberg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-11-06 with Medical categories.
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.
Good Laboratory Practice
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Author : Jürg P. Seiler
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
Good Laboratory Practice written by Jürg P. Seiler and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.
After more than twenty years of use Good Laboratory Practice, or GLP, has attained a secure place in the world of testing chemicals and other "test items" with regard to their safety for humans and the environment. Gone are the days when the GLP regulations were hotly debated amongst scientists in academia and industry and were accused of stifling flexibility in, imaginative approaches to, and science-based conduct of, all kinds of studies concerned with toxic effects and other parameters important for the evaluation and assessment of products submitted for registration and permission to market. The GLP regulations have developed from rules on how to exactly document the planning, conduct and reporting of toxicity studies to a quality system for the management of a multitude of study types, from the simple determination of a physical/chemical parameter to the most complex field tests or ecotoxicology studies. At the same time the term "Good Laboratory Practice" has become somewhat of a slogan with the aim to characterise any reliably conducted laboratory work.
Good Laboratory Practice Regulations Revised And Expanded
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Author : Sandy Weinberg
language : en
Publisher: CRC Press
Release Date : 2002-11-06
Good Laboratory Practice Regulations Revised And Expanded written by Sandy Weinberg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-11-06 with Medical categories.
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general g
Good Laboratory Practice Regulations Fourth Edition
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Author : Sandy Weinberg
language : en
Publisher: CRC Press
Release Date : 2007-01-19
Good Laboratory Practice Regulations Fourth Edition written by Sandy Weinberg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-01-19 with Medical categories.
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings. This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the assurance of compliance in numerous research environments. Providing insights for the application of GLP regulations and emphasizing the latest regulatory developments, this reference discusses the implementation of PAT and emphasizes the importance of electronic audit trails and data controls as laboratories rely more on automated procedures...gives clear rules for the acceptance of electronic signatures, archiving of data in formats accessible by electronic recovery and human retrieval, and the security of electronic documents...and details the FDA’s GLP inspection program.
Good Laboratory Practice Standards Inspection Manual
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Author : U.S. Environmental Protection Agency
language : en
Publisher: Government Inst
Release Date : 1994-01-01
Good Laboratory Practice Standards Inspection Manual written by U.S. Environmental Protection Agency and has been published by Government Inst this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994-01-01 with Science categories.
Includes detailed questions EPA will ask when conducting inspections, techniques, recordkeeping, GLP Compliance review, audit procedures, post-inspection activities, and more
Good Laboratory Practice Regulations Third Edition Revised And Expanded
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Author : Sandy Weinberg
language : en
Publisher: CRC Press
Release Date : 2002-11-06
Good Laboratory Practice Regulations Third Edition Revised And Expanded written by Sandy Weinberg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-11-06 with Medical categories.
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.
Good Laboratory Practice Regulations
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Author : Sandy Weinberg
language : en
Publisher: CRC Press
Release Date : 1995
Good Laboratory Practice Regulations written by Sandy Weinberg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1995 with Business & Economics categories.
This work covers all aspects of the Food and Drug Administration's Good Laboratory Practice relgulations and techniques for implementation. This edition includes general knowledge on computer system validation, details on implementing GIPs in an automated laboratory, a forecast of the flexibility and effectiveness of GLPs in the changing laboratory environment, and a contemporary bibliography with new references.
Good Laboratory Practice Standards
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Author : W.Y. Garner
language : en
Publisher:
Release Date : 1992
Good Laboratory Practice Standards written by W.Y. Garner and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with categories.