Martin D. Hynes 
Preparing for FDA Pre-Approval Inspections [EPUB ebook] 
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. Th