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Book Detail

Good Laboratory Practice Regulations, Fourth Edition
Editor(s) :Sandy Weinberg

ISBN	:	9780367411374
Name	:	Good Laboratory Practice Regulations, Fourth Edition
Price	:	3495.00
Edition	:	Fourth Edition
Editor/s	:	Sandy Weinberg
Type	:	Reference Book
Pages	:	294
Year of Publication	:	Rpt. 2023
Publisher	:	CRC Press / BSP Books
Binding	:	Hardback

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About the Book:

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 addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings. This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the assurance of compliance in numerous research environments.

Providing insights for the application of GLP regulations and emphasizing the latest regulatory developments, this reference discusses the implementation of PAT and emphasizes the importance of electronic audit trails and data controls as laboratories rely more on automated procedures…gives clear rules for the acceptance of electronic signatures, archiving of data in formats accessible by electronic recovery and human retrieval, and the security of electronic documents…and details the FDA’s GLP inspection program.

Contents:

1. Historical Perspective

2. FDA/GLP Regulations

3. Regulations of Computer Systems

4. The Good Automated Laboratory Practices

5. Implementing GLPs in a Non-GLP Analytical Laboratory

6. Controlling the Good Laboratory Practices Inspection Process

7. Computer Systems Validation

8. GLP Documentation

9. The FDA’s GLP Inspection Program

10. The Future of Good Laboratory Practice Regulations

About the Author:

Sandy Weinberg is vice President for Regulatory and Quality Assurance, Tikvah Therapeutics, Inc., Atlanta, Georgia. Before this position, he headed the Biodefense Project at GE Healthcare, Atlanta, Georgia, and was the Linnaeus Chair of Biomedical Entrepreneurship, Muhlenberg College, Allentown, Pennsylvania. The author of numerous professional publications, Dr. Weinberg possesses over 25 years of regulatory experience, holds several patents, and has served as a consultant for governmental agencies in U. S. and abroad. He received the Ph.D. degree from the University of Michigan, Ann Arbor, and completed postdoctoral work in computer science and engineering at the University of Florida, Gainesville.

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