Good Laboratory Practice Regulations Revised And Expanded

Author : Sandy Weinberg
Publisher : CRC Press
Page : 256 pages
File Size : 44,7 Mb
Release : 2002-11-06
Category : Medical
ISBN : 9780824745646

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Good Laboratory Practice Regulations, Third Edition, Revised and Expanded by Sandy Weinberg Pdf

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.

Author : Sandy Weinberg
Publisher : CRC Press
Page : 249 pages
File Size : 48,7 Mb
Release : 2002-11-06
Category : Medical
ISBN : 9780203911082

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Good Laboratory Practice Regulations, Revised and Expanded by Sandy Weinberg Pdf

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

Author : Sandy Weinberg
Publisher : CRC Press
Page : 304 pages
File Size : 42,6 Mb
Release : 2007-01-19
Category : Medical
ISBN : 9780849375842

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Good Laboratory Practice Regulations by Sandy Weinberg Pdf

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 addresse

Author : Sandy Weinberg
Publisher : CRC Press
Page : 264 pages
File Size : 40,5 Mb
Release : 2002-11-06
Category : Medical
ISBN : 1135552509

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Good Laboratory Practice Regulations, Third Edition, Revised and Expanded by Sandy Weinberg Pdf

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.

Author : Willa Y. Garner,Maureen S. Barge,James P. Ussary
Publisher : Oxford University Press, USA
Page : 600 pages
File Size : 49,6 Mb
Release : 1992
Category : Pesticides
ISBN : UCAL:B4526096

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Good Laboratory Practice Standards by Willa Y. Garner,Maureen S. Barge,James P. Ussary Pdf

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.

Author : United States. Food and Drug Administration
Publisher : Unknown
Page : 60 pages
File Size : 51,8 Mb
Release : 1979
Category : Laboratories
ISBN : UCAL:C3121445

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Good Laboratory Practice Regulations Management Briefings by United States. Food and Drug Administration Pdf

Author : Sandy Weinberg
Publisher : CRC Press
Page : 320 pages
File Size : 41,6 Mb
Release : 1995
Category : Biological laboratories
ISBN : STANFORD:36105012419888

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Good Laboratory Practice Regulations by Sandy Weinberg Pdf

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.

Author : Milton A. Anderson
Publisher : CRC Press
Page : 67 pages
File Size : 48,6 Mb
Release : 2002
Category : Medical
ISBN : 1574911384

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GLP Essentials by Milton A. Anderson Pdf

Concise and easy to follow, this book explains the implementation of Good Laboratory Practices (GLPs). The second edition of a standard reference, GLP Essentials identifies and describes the required elements of managing a scientific study including its planning, performance, reporting, and monitoring. The author includes a brief, informative discussion of the historical development of GLPs and the rationale for establishing these requirements in the rapidly expanding scientific research and regulatory environment. Written especially for readers involved in ensuring the integrity of their scientific documentation, this book is useful for individual and group training programs.

Author : Mindy J. Allport-Settle
Publisher : Pharmalogika
Page : 276 pages
File Size : 50,5 Mb
Release : 2010-10
Category : Medical
ISBN : 0983071918

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Good Laboratory Practice by Mindy J. Allport-Settle Pdf

This book is designed to be a unified reference source for the U.S. Food and Drug Adminstration's Good Laboratory Practice regulations, guidance, and associated documents for pharmaceutical, biologics and medical device products nonclinical trials. Good Laboratory Practice Regulations and Guidance: * FDA Overview and Orientation * Overview of GCP and Introduction to GLP * Part I: Federal Regulations Relating to Good Laboratory Practice o Parts 58: Good Laboratory Practice for Nonclinical Laboratory Studies o 1987 Final Rule - Good Laboratory Practice Regulations * Part II: Guidance Documents o Bioresearch Monitoring Good Laboratory Practice o Good Laboratory Practices Questions and Answers * Part III: Redbook 2000 o IV.B.1 General Guidelines for Designing and Conducting Toxicity Studies o IV.B.2 Guidelines for Reporting the Results of Toxicity Studies Reference Tools * Part IV: Combined Glossary and Index

Author : Jürg P. Seiler
Publisher : Springer Science & Business Media
Page : 404 pages
File Size : 44,7 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9783642868788

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Good Laboratory Practice by Jürg P. Seiler Pdf

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.

Author : Graham P. Bunn
Publisher : CRC Press
Page : 179 pages
File Size : 51,7 Mb
Release : 2022-12-13
Category : Medical
ISBN : 9781000789591

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Good Laboratory Practice for Nonclinical Studies by Graham P. Bunn Pdf

The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed. • Unique volume covering FDA inspections of GLP facilities • Provides a detailed interpretation of GLP Regulations • Presents the latest on electronic data management in GLP • Describes GLP and computer systems validation • Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements

Author : George Edward Paget
Publisher : Unknown
Page : 232 pages
File Size : 50,9 Mb
Release : 1979
Category : Medical
ISBN : UOM:39015006012333

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Good Laboratory Practice by George Edward Paget Pdf

Author : Food and Drug Administration
Publisher : CRC Press
Page : 54 pages
File Size : 42,5 Mb
Release : 2002-09-30
Category : Medical
ISBN : 9781135489663

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Compact Regs Part 58 by Food and Drug Administration Pdf

The Compact Regs series provides full-text, pocket-sized format (3 3/4 inch x 5 1/2 inch) verbatim reproductions of key US FDA regulations. The texts are complete and have not been altered in any manner from the original sources. They are the perfect low-cost tools for: employees as part of documented GMP training programs, for suppliers/vendors so

Author : Interpharm
Publisher : CRC Press
Page : 72 pages
File Size : 49,9 Mb
Release : 2013-10-23
Category : Medical
ISBN : 9781482207996

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Compact Regs Part 58 by Interpharm Pdf

This publication contains a verbatim reproduction of 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies.

Author : Gregory E Hardee,J D Baggot
Publisher : CRC Press
Page : 354 pages
File Size : 51,7 Mb
Release : 2021-04-30
Category : Medical
ISBN : 9781000454178

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Development and Formulation of Veterinary Dosage Forms by Gregory E Hardee,J D Baggot Pdf

Although the United States (U.S.) and the more developed nations of the remainder of the world are blessed with a variety of pharmaceuticals, feed additives, and biological products to treat, prevent, and control animal diseases, there is a healthy desire among persons involved in animal health issues to increase our animal medicine chest. The interest stems from the desire to efficiently produce food that is safe and plentiful and from the desire to have more and better government-approved products available for the prevention and treatment of diseases of dogs, cats, and horses and for an increasing variety of minor animal species. For the animal health industry, increased drug availability means broader markets, increased revenues, and an opportunity to better serve their customers. For the veterinarian, more animal health products means that he or she is better able to treat the usual and the unusual conditions, and to prevent animal disease and suffering. No doubt, we are all winners when new technology and industrial and regulatory initiatives hasten the availability of safe and effective animal health products.