Martin D. Hynes 
Preparing for FDA Pre-Approval Inspections [EPUB 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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格式 EPUB ● 网页 304 ● ISBN 9781000654370 ● 编辑 Martin D. Hynes ● 出版者 CRC Press ● 发布时间 2016 ● 下载 3 时 ● 货币 EUR ● ID 7352352 ● 复制保护 Adobe DRM
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