Preparing for FDA Pre-Approval Inspections (eBook, PDF)

A Guide to Regulatory Success, Second Edition
Redaktion: Hynes, Martin D.

• Format: PDF

Produktbeschreibung

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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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 304
• Erscheinungstermin: 19. April 2016
• Englisch
• ISBN-13: 9781420020489
• Artikelnr.: 42619517