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 Product 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. DOWNLOAD LINK: http://rapidshare.com/files/137661886/tpharma_preappr_inspect2ed.zip

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