Good Laboratory Practice for Nonclinical Studies

Name: Good Laboratory Practice for Nonclinical Studies
SKU: 138558
Price: 7 USD
Availability: InStock

7 $

Format : Publisher PDF

File Size : 10.5 MB

Category: Laboratory Books

Description

Good Laboratory Practice for Nonclinical Studies

By Graham P. Bunn

The GLP regulations, enacted in 1978, are an essential part of the pharmaceutical and biotechnology industry. However, as technology advances, the need for updates and revisions to these regulations becomes evident. That’s where Graham P. Bunn’s book, “Interpreting the GLP Regulations: A Guide for Professionals,” comes in. With his expertise and knowledge in the field, Bunn provides a unique opportunity to access interpretations of the 21CFR58 regulatory requirements.

Understanding the GLP Regulations

The Good Laboratory Practice (GLP) regulations are crucial for ensuring the quality and integrity of data generated in nonclinical laboratory studies. They are designed to promote the validity, accuracy, reliability, and integrity of test data. Compliance with these regulations is essential for regulatory submissions and obtaining marketing approvals for pharmaceuticals and biotechnology products.

In “Interpreting the GLP Regulations: A Guide for Professionals,” Bunn offers comprehensive insights into the GLP regulations and their interpretations. The book guides readers through the requirements of 21CFR58 and provides valuable references to examples and regulatory actions. Whether you are new to the industry or an experienced professional, this book will prove to be an invaluable resource in navigating the complexities of the GLP regulations.

Expert Interpretations and Electronic Data Management

The book covers a diverse range of topics, including FDA inspections of GLP facilities, data integrity, and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures. With contributions from leading industry experts, “Interpreting the GLP Regulations: A Guide for Professionals” ensures that readers receive accurate and up-to-date information.

One significant aspect covered in the book is the latest information on electronic data management in GLP. As technology continues to evolve, the use of electronic systems for data storage and management has become increasingly common. Bunn discusses the best practices for incorporating electronic systems into GLP compliance, ensuring data integrity, and meeting regulatory requirements.

An Invaluable Resource for Daily Implementation

“Interpreting the GLP Regulations: A Guide for Professionals” is not merely a book to be read once and forgotten. Its practical approach allows readers to refer back to it repeatedly for supporting their daily hands-on implementation of the CFR requirements. The clear interpretations and references to examples make it easier for professionals to understand and apply the regulations in their work.

Order “Interpreting the GLP Regulations: A Guide for Professionals” Now

Whether you are a seasoned professional in the pharmaceutical and biotechnology industry or just starting your career, “Interpreting the GLP Regulations: A Guide for Professionals” is a must-have resource. The expertise and insights shared in this book will help you navigate the complex landscape of GLP regulations with ease and confidence.

Order your copy of “Interpreting the GLP Regulations: A Guide for Professionals” today and stay ahead of the curve in ensuring compliance and maintaining data integrity in your laboratory studies.