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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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Omslag till Martin D. Hynes: Preparing for FDA Pre-Approval Inspections (PDF)

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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Språk Engelska ● Formatera PDF ● Sidor 304 ● ISBN 9781420020489 ● Redaktör Martin D. Hynes ● Utgivare CRC Press ● Publicerad 2016 ● Nedladdningsbara 3 gånger ● Valuta EUR ● ID 4115067 ● Kopieringsskydd Adobe DRM

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