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Preparing for FDA Pre-Approval Inspections
Preparing for FDA Pre-Approval Inspections
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Preparing for FDA Pre-Approval Inspections

Engelsk
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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. Th
Undertittel
A Guide to Regulatory Success, Second Edition
ISBN
9781420020489
Språk
Engelsk
Utgivelsesdato
19.4.2016
Forlag
CRC PRESS
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