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GLP Regulations Handbook from C.H.I.P.S.

Good Laboratory Practice Regulations Fourth edition
edited by Sandy Weinberg

Good Laboratory Practice Regulations 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
  • 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
  • details the FDA's GLP inspection program

Contents

  1. Historical Perspective
  2. FDA/GLP Regulations
  3. Applying 21 CFR Part 11 to the Laboratory Environment
  4. The Good Automated Laboratory Practices
  5. Implementing GLPs in a Non-GLP Analytical Laboratory
  6. Controlling the GLP Inspection Process
  7. Computer Systems Validation
  8. GLP Documentation
  9. The FDA's GLP Inspection Program
  10. The Future of Good Laboratory Practice Regulations

Index

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Good Laboratory Practice Regulations
Fourth edition
edited by Sandy Weinberg

2007 285 pages $228.95 + shipping
Texas residents please add 6.75 % sales tax

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