Book: Pharmaceutical Pre-approval Inspections: A Guide To Regulatory Success, Second Edition (drugs And The Pharmaceutical Sciences) 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.
Details of Book: Pharmaceutical Pre-approval Inspections: A Guide To Regulatory Success, Second Edition (drugs And The Pharmaceutical Sciences) Book: Pharmaceutical Pre-approval Inspections: A Guide To Regulatory Success, Second Edition (drugs And The Pharmaceutical Sciences)
Author: Hynes Martin D. Iii
ISBN: 0849391849
ISBN-13: 9780849391842
, 978-0849391842
Binding: Hardcover
Publishing Date: 2008/03/06
Publisher: Informa Healthcare
Number of Pages: 278
Language: English