Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition

2nd Edition

Martin D. Hynes

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CRC Press
Published April 19, 2016
Reference - 304 Pages
ISBN 9780429120985 - CAT# KE79944

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Summary

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. Th

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