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{
"item_title" : "Preparing for FDA Pre-Approval Inspections",
"item_author" : [" Martin D. Hynes "],
"item_description" : "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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Preparing for FDA Pre-Approval Inspections : A Guide to Regulatory Success, Second Edition
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Overview
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.
This item is Non-Returnable
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Details
- ISBN-13: 9780367452711
- ISBN-10: 0367452715
- Publisher: CRC Press
- Publish Date: December 2019
- Dimensions: 9 x 6 x 0.63 inches
- Shipping Weight: 0.89 pounds
- Page Count: 304
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