Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition

Book Overview

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.

• Format: Paperback
• Language: English
• ISBN: 0367452715
• ISBN13: 9780367452711
• Release Date: December 2019
• Publisher: CRC Press
• Length: 304 Pages
• Weight: 0.89 lbs.
• Dimensions: 0.6" x 6.0" x 9.0"