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Monday, February 7, 2011

Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition



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 21stCentury, 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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Posted by Aakash Gagan Sky at 5:30 AM
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