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Practical Pharmaceutical Regulatory Handbook
from C.H.I.P.S.

Pharmaceutical
Pre-Approval Inspections

A Guide to Regulatory Success
Second edition
edited by Martin D. Hynes III

Pharmaceutical Pre-Approval Inspections Second edition is an essential guide to preparing for FDA pre-approval inspections—taking into account current trends in FDA expectations and inspection activities, such as:

  • the GMPs of the 21st Century
  • quality systems-based approach to inspections
  • risk-based inspections
  • quality by design
  • process analytical technology
  • design space, etc.

The goal of this book is to help organizations gain rapid regulatory approval.

Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition

  • chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspections
  • demonstrates what each area of pharmaceutical development, from research and development to training, is expected to provide to inspectors
  • focuses on traditional development and submission activities, but also discusses cases where the transfer is from a domestic site to an international facility

Contents

  1. The Evolution of the Food and Drug Administration: Pre-New Druig Application Approval Inspection
  2. FDS's Risk-Based Approach to Inspections
  3. Critical Role of the Pharmaceutical Scientist in Product Development and Preparing for Pre-approval Inspections
  4. Training Requirements in Product Development: A Key to a Successful Pre-Approval Inspection
  5. A cGMP Risk Assessment and Management Strategy: Guidelines for the Pre-Approval Inspection
  6. Concepts in Quality by Design for Drug Development and Manufacture
  7. Equipment Cleaning During Pharmaceutical Product Development and Its Importance to Pre-Approval Inspection
  8. Conducting Stability Studies During Development to Ensure Successful Regulatory Approval
  9. Computer Systems Validation During the Drug Development Process in Anticipation of Pre-Approval Inspections
  10. Integral for Successful PAI: The Quality Assessment Program
  11. All Dressed Up but No Approval to Go: The Consequence of Failing an FDA Pre-Approval Inspection

Index

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Pharmaceutical Pre-Approval Inspections
A Guide to Regulatory Success
Second edition
edited by Martin D. Hynes III

2008 • 278 pages • $228.95 + shipping
Texas residents please add 6.75 % sales tax

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