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Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition
Paperback
ISBN13: 9780367452711
Publisher: Crc Pr Inc
Published: Dec 2 2019
Pages: 304
Weight: 0.89
Height: 0.63 Width: 6.00 Depth: 9.00
Language: English
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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