Description
Informa Healthcare Pharmaceutical Pre-Approval Inspections A Guide To Regulatory Success 2E (Hb) by Hynes
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.
Key Features:-
- chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspe
- demonstrates what each area of pharmaceutical development, from research and development to training
- focuses on traditional development and submission activities, but also discusses cases where the tra