Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition
By addebook • Aug 18th, 2008 • Category: Pharmacy •
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Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences)
Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences)
By Martin D. Hynes III
Publisher: Informa HealthCare
Number Of Pages: 304
Publication Date: 2008-03-05
ISBN-10 / ASIN: 0849391849
ISBN-13 / EAN: 9780849391842
Binding: Hardcover
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.
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