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

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