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Preparing for FDA Pre-Approval Inspections (A Guide to Regulatory Success, Second Edition)
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Product Details
Author:
Martin D. Hynes
Format:
Paperback
Pages:
304
Publisher:
CRC Press (December 2, 2019)
Language:
English
ISBN-13:
9780367452711
Weight:
16oz
Dimensions:
6" x 9"
File:
TAYLORFRANCIS-TayFran_260406043133783-20260406.xml
Folder:
TAYLORFRANCIS
List Price:
$87.99
Case Pack:
1
As low as:
$83.59
Publisher Identifier:
P-CRC
Discount Code:
H
Audience:
Professional and scholarly
Country of Origin:
United States
Pub Discount:
30
Imprint:
CRC Press
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.
Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition:
- chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspections
- demonstrates what each area of pharmaceutical development, from research and development to training, is expected to provide to inspectors
- focuses on traditional development and submission activities, but also discusses cases where the transfer is from a domestic site to an international facility
