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9780849391842

Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition

by ;
  • ISBN13:

    9780849391842

  • ISBN10:

    0849391849

  • Edition: 2nd
  • Format: Hardcover
  • Copyright: 2008-03-05
  • Publisher: CRC Press

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Summary

This Second Editionis 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 21 st 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. 

Table of Contents

Prefacep. iii
Acknowledgmentsp. v
Contributorsp. ix
The Evolution of the Food and Drug Administration: Pre-New Drug Application Approval Inspectionp. 1
FDA's Risk-Based Approach to Inspectionsp. 27
Critical Role of the Pharmaceutical Scientist in Product Development and Preparing for Pre-Approval Inspectionsp. 59
Training Requirements in Product Development: A Key to a Successful Pre-Approval Inspectionp. 83
The Systems-Based Pre-Approval Inspectionp. 95
A cGMP Risk Assessment and Management Strategy: Guidelines for the Pre-Approval Inspectionp. 107
Concepts in Quality by Design for Drug Development and Manufacturep. 149
Equipment Cleaning During Pharmaceutical Product Development and Its Importance to Pre-Approval Inspectionp. 191
Conducting Stability Studies During Development to Ensure Successful Regulatory Approvalp. 207
Computer Systems Validation During the Drug Development Process in Anticipation of Pre-Approval Inspectionsp. 225
Integral for Successful PAI: The Quality Assessment Programp. 243
All Dressed Up but No Approval to Go: The Consequence of Failing an FDA Pre-Approval Inspectionp. 261
Indexp. 265
Table of Contents provided by Ingram. All Rights Reserved.

Supplemental Materials

What is included with this book?

The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.

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