Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition (2)
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- Synopsis
- 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
- Copyright:
- 2008
Book Details
- Book Quality:
- Publisher Quality
- Book Size:
- 304 Pages
- ISBN-13:
- 9781000654370
- Related ISBNs:
- 9780429120985, 9780367452711, 9780849391842
- Publisher:
- CRC Press
- Date of Addition:
- 07/13/23
- Copyrighted By:
- Informa Healthcare USA, Inc.
- Adult content:
- No
- Language:
- English
- Has Image Descriptions:
- No
- Categories:
- Nonfiction, Science, Medicine
- Submitted By:
- Bookshare Staff
- Usage Restrictions:
- This is a copyrighted book.
- Edited by:
- Martin D. Hynes