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Martin D. Hynes
Preparing for FDA Pre-Approval Inspections [PDF ebook]
A Guide to Regulatory Success, Second Edition

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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

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Língua Inglês ● Formato PDF ● Páginas 304 ● ISBN 9781420020489 ● Editor Martin D. Hynes ● Editora CRC Press ● Publicado 2016 ● Carregável 3 vezes ● Moeda EUR ● ID 4115067 ● Proteção contra cópia Adobe DRM

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