Good Laboratory Practice Regulations
eBook - PDF

Good Laboratory Practice Regulations

  1. 304 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Good Laboratory Practice Regulations

Book details
Table of contents
Citations

About This 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 addresse

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Yes, you can access Good Laboratory Practice Regulations by Sandy Weinberg, James Swarbrick in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2007
ISBN
9780849375842
Edition
4
Subtopic
Pharmacology

Table of contents

  1. Front cover
  2. Preface
  3. Contents
  4. Contributors
  5. Chapter 1. Historical Perspective
  6. Chapter 2. FDA/GLP Regulations
  7. Chapter 3. Regulation of Computer Systems
  8. Chapter 4. The Good Automated Laboratory Practices
  9. Chapter 5. Implementing GLPs in a Non-GLP Analytical Laboratory
  10. Chapter 6. Controlling the Good Laboratory Practices Inspection Process
  11. Chapter 7. Computer Systems Validation
  12. Chapter 8. GLP Documentation
  13. Chapter 9. The FDA's Inspection Program
  14. Chapter 10. The Future of the Good Laboratory Practice Regulations
  15. Index
  16. Back cover