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| Author | : United States. Food and Drug Administration |
| Publisher | : |
| Total Pages | : |
| Release | : 1995 |
| Genre | : |
| ISBN | : 9780940701519 |
| Author | : |
| Publisher | : |
| Total Pages | : 42 |
| Release | : 1993 |
| Genre | : |
| ISBN | : 9780940701410 |
| Author | : Sandy Weinberg |
| Publisher | : CRC Press |
| Total Pages | : 249 |
| Release | : 2002-11-06 |
| Genre | : Medical |
| ISBN | : 0203911083 |
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 | : United States. Food and Drug Administration |
| Publisher | : |
| Total Pages | : 60 |
| Release | : 1979 |
| Genre | : Laboratories |
| ISBN | : |
| Author | : Sandy Weinberg |
| Publisher | : CRC Press |
| Total Pages | : 256 |
| Release | : 2002-11-06 |
| Genre | : Medical |
| ISBN | : 0824745647 |
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 | : United States. Food and Drug Administration |
| Publisher | : |
| Total Pages | : 42 |
| Release | : 1992 |
| Genre | : |
| ISBN | : 9780940701304 |
| Author | : Graham P. Bunn |
| Publisher | : CRC Press |
| Total Pages | : 179 |
| Release | : 2022-12-13 |
| Genre | : Medical |
| ISBN | : 1000789594 |
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 | : Sandy Weinberg |
| Publisher | : CRC Press |
| Total Pages | : 306 |
| Release | : 2007-01-19 |
| Genre | : Medical |
| ISBN | : 0849375843 |
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 | : Food and Drug Administration |
| Publisher | : CRC Press |
| Total Pages | : 54 |
| Release | : 2002-09-30 |
| Genre | : Medical |
| ISBN | : 1135489661 |
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 |
| Total Pages | : 72 |
| Release | : 2013-10-23 |
| Genre | : Medical |
| ISBN | : 1482207990 |
This publication contains a verbatim reproduction of 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies.
