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Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition 2nd edition
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Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition
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. 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
304 pages
| Media | Books Paperback Book (Book with soft cover and glued back) |
| Released | December 2, 2019 |
| ISBN13 | 9780367452711 |
| Publishers | Taylor & Francis Ltd |
| Pages | 304 |
| Dimensions | 150 × 220 × 10 mm · 453 g |
| Language | English |
| Editor | Hynes, Martin D. |
