Description

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

More Details about Pharmaceutical Pre-Approval Inspections A Guide to Regulatory Success 2e (HB)

General Information  
Author(s)Hynes
PublisherInforma Healthcare
Edition2
ISBN9780849391842
Pages278
BindingHard Back
LanguageEnglish
Publish YearJanuary 2008