Preparing for FDA Pre-Approval Inspections
Author | : Martin D. Hynes |
Publisher | : CRC Press |
Total Pages | : 310 |
Release | : 2016-04-19 |
ISBN-10 | : 9781000654370 |
ISBN-13 | : 1000654370 |
Rating | : 4/5 (370 Downloads) |
Book Synopsis Preparing for FDA Pre-Approval Inspections by : Martin D. Hynes
Download or read book Preparing for FDA Pre-Approval Inspections written by Martin D. Hynes and published by CRC Press. This book was released on 2016-04-19 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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