Good Laboratory Practice Regulations Revised And Expanded
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Author | : Sandy Weinberg |
Publisher | : CRC Press |
Total Pages | : 249 |
Release | : 2002-11-06 |
Genre | : Medical |
ISBN | : 0203911083 |
Download Good Laboratory Practice Regulations, Revised and Expanded Book in PDF, Epub and Kindle
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 |
Total Pages | : 256 |
Release | : 2002-11-06 |
Genre | : Medical |
ISBN | : 0824745647 |
Download Good Laboratory Practice Regulations, Third Edition, Revised and Expanded Book in PDF, Epub and Kindle
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 |
Total Pages | : 306 |
Release | : 2007-01-19 |
Genre | : Medical |
ISBN | : 0849375843 |
Download Good Laboratory Practice Regulations Book in PDF, Epub and Kindle
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 |
Total Pages | : 264 |
Release | : 2002-11-06 |
Genre | : Medical |
ISBN | : 9781135552503 |
Download Good Laboratory Practice Regulations, Third Edition, Revised and Expanded Book in PDF, Epub and Kindle
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 | : Jürg P. Seiler |
Publisher | : Springer Science & Business Media |
Total Pages | : 404 |
Release | : 2012-12-06 |
Genre | : Medical |
ISBN | : 3642868789 |
Download Good Laboratory Practice Book in PDF, Epub and Kindle
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 | : United States. Food and Drug Administration |
Publisher | : |
Total Pages | : 60 |
Release | : 1979 |
Genre | : Laboratories |
ISBN | : |
Download Good Laboratory Practice Regulations Management Briefings Book in PDF, Epub and Kindle
Author | : Sandy Weinberg |
Publisher | : CRC Press |
Total Pages | : 320 |
Release | : 1995 |
Genre | : Biological laboratories |
ISBN | : |
Download Good Laboratory Practice Regulations Book in PDF, Epub and Kindle
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 | : Mindy J. Allport-Settle |
Publisher | : Pharmalogika |
Total Pages | : 276 |
Release | : 2010-10 |
Genre | : Medical |
ISBN | : 9780983071914 |
Download Good Laboratory Practice Book in PDF, Epub and Kindle
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 | : Philip Carson |
Publisher | : Royal Society of Chemistry |
Total Pages | : 657 |
Release | : 2007-10-31 |
Genre | : Science |
ISBN | : 1847557724 |
Download Good Clinical, Laboratory and Manufacturing Practices Book in PDF, Epub and Kindle
Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
Author | : Graham P. Bunn |
Publisher | : |
Total Pages | : 0 |
Release | : 2023 |
Genre | : |
ISBN | : 9781032381152 |
Download FDA Good Laboratory Practice Requirements Book in PDF, Epub and Kindle
"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"--