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Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success

Second Edition

Printed Book
SR 397
Inclusive of VAT
Sold as: EACH
SR24Per Month/24 months
Author:Hynes, Martin D.
Date of Publication: 2019
Book classification:Medical Books,English Books,English Books,
No. of pages:302 Pages
Format:Paperback

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About this Product

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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Specifications

SKU9780367452711
Manufacturer Number9780367452711
year published2019
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