Preparing for FDA Pre-Approval Inspections
A Guide to Regulatory Success, Second Edition| By: | null |
| Publisher: | Taylor & Francis |
| Print ISBN: | 9780849391842 |
| eText ISBN: | 9781000654370 |
| Edition: | 2 |
| Copyright: | 2008 |
| Format: | Reflowable |
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This 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. Th