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Preface | p. iii |
Acknowledgments | p. v |
Contributors | p. ix |
The Evolution of the Food and Drug Administration: Pre-New Drug Application Approval Inspection | p. 1 |
FDA's Risk-Based Approach to Inspections | p. 27 |
Critical Role of the Pharmaceutical Scientist in Product Development and Preparing for Pre-Approval Inspections | p. 59 |
Training Requirements in Product Development: A Key to a Successful Pre-Approval Inspection | p. 83 |
The Systems-Based Pre-Approval Inspection | p. 95 |
A cGMP Risk Assessment and Management Strategy: Guidelines for the Pre-Approval Inspection | p. 107 |
Concepts in Quality by Design for Drug Development and Manufacture | p. 149 |
Equipment Cleaning During Pharmaceutical Product Development and Its Importance to Pre-Approval Inspection | p. 191 |
Conducting Stability Studies During Development to Ensure Successful Regulatory Approval | p. 207 |
Computer Systems Validation During the Drug Development Process in Anticipation of Pre-Approval Inspections | p. 225 |
Integral for Successful PAI: The Quality Assessment Program | p. 243 |
All Dressed Up but No Approval to Go: The Consequence of Failing an FDA Pre-Approval Inspection | p. 261 |
Index | p. 265 |
Table of Contents provided by Ingram. All Rights Reserved. |
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.
The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.