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Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition
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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.
Download Link:
http://rapidshare.com/files/137661886/tpharma_preappr_inspect2ed.zip
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Posted in books by kdsaggi
on Aug. 16, 2008 // 06:38
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