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Good Laboratory Practice for Nonclinical Studies 1st Edition 2022 Hardbound at Meripustak

Good Laboratory Practice for Nonclinical Studies 1st Edition 2022 Hardbound

Books from same Author: Bunn, Graham P.

Books from same Publisher: CRC Press

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    • General Information  
    Author(s)Bunn, Graham P.
    PublisherCRC Press
    Edition1st Edition
    ISBN9780367336271
    Pages194
    BindingHardbound
    LanguageEnglish
    Publish YearDecember 2022

    Description

    CRC Press Good Laboratory Practice for Nonclinical Studies 1st Edition 2022 Hardbound by Bunn, Graham P.

    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