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Preparing for FDA Pre-Approval Inspections

By Hynes, Martin D.

Preparing for FDA Pre-Approval Inspections Medicine

Preparing for FDA Pre-Approval Inspections

By Hynes, Martin D.

0 - Default Title
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.
Product details
Binding:
Paperback
Edition:
2
Number of Pages:
302
Release Date:
2019-12-02
Publication Date:
2019-12-02
Publisher:
CRC Press
Languages:
Original: English
ISBN10:
0367452715
ISBN13:
9780367452711
GPSR Manufacturer Reference:
[email protected]
Weight:
441 g
Height:
152 cm
Width:
229 cm
Thickness:
16 cm
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