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Reference - Good Laboratory Practice for Nonclinical Studies (Drugs and the Pharmaceutical Sciences)

Description

Book Synopsis: 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 Read more

Details

Looking for a comprehensive guide to navigate the world of Good Laboratory Practice (GLP) regulations? Look no further than our latest release - "Good Laboratory Practice for Nonclinical Studies." With GLP regulations continuously evolving, this book offers valuable insights and interpretations from industry experts who have an in-depth understanding of the field.

Stay up to date with the proposed FDA amendment that aims to revise terminology and align with the latest technological advancements in the industry. Our book not only provides interpretation of the 21CFR58 regulatory requirements, but it also offers real-life examples and references to regulatory actions, ensuring a practical understanding of GLP compliance.

One of the key aspects covered in the book is data integrity, a crucial factor in nonclinical studies. Additionally, we delve into the intricacies of using electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures. This valuable resource will empower you to confidently navigate the challenges associated with electronic data management while maintaining compliance.

Our book is the go-to reference for FDA inspections of GLP facilities. It dives deep into the nuances of GLP regulations and also highlights the importance of computer system validation. Whether you are a seasoned professional or just starting your journey in the pharmaceutical industry, this book will be your daily companion in implementing the CFR requirements.

Don't miss out on this opportunity to enhance your knowledge and stay ahead of the regulatory curve. Get your copy of "Good Laboratory Practice for Nonclinical Studies" today!

Click here to order now!

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