eBook - ePub

Good Laboratory Practice for Nonclinical Studies

Name: Good Laboratory Practice for Nonclinical Studies
ISBN: 9781000789591

Graham P. Bunn,

192 pages
English
ePUB (mobile friendly)
Available on iOS & Android

eBook - ePub

Good Laboratory Practice for Nonclinical Studies

Graham P. Bunn,

About this book

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

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Yes, you can access Good Laboratory Practice for Nonclinical Studies by Graham P. Bunn in PDF and/or ePUB format, as well as other popular books in Medicine & Science History & Practice. We have over one million books available in our catalogue for you to explore.