Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition, 2nd Edition (e-Book) book cover

Preparing for FDA Pre-Approval Inspections

A Guide to Regulatory Success, Second Edition, 2nd Edition

Edited by Martin D. Hynes

CRC Press

304 pages

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Hardback: 9780849391842
pub: 2008-03-05
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pub: 2016-04-19
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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

Table of Contents

Introduction/Preface.� Pre-Approval Inspection: A Historical Overview.� Recent Trends in Domestic and International Pre-Approval Inspections.� The Implications of the Quality Systems, Risk Based Inspections and 21st Century GMPs to Preparing for FDA Pre-Approval Inspections.� Preparing for FDA Pre-Approval Inspections Similarities and Differences between Center for Biologics Evaluation and Research (CBER) / Center for Drug Evaluation and Research (CDER).� The GMP Risk Assessment, Guidance for Preparing for Pre-Approval Inspections, Traditional and Non-Traditional.� The Product Development Drill, the Importance of Good Science, Stability Data, Scale Up, and Validation to Successfully Passing a Pre-Approval Inspection.� The History of Development Documents: Guidance for Preparation in Light of Recent Trends.� Computer Validation Systems Validation during the Drug Development Process.� The Use of Audits during the Drug Development Process to Assure a Successful Pre-Approval Inspection.� The Consequence of a Poor Product Development Process and Failing a Pre-Approval Inspection.�

About the Editor

MARTIN D. HYNES III is Director of Product Research and Development and Six Sigma Champion at Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana. Dr. Hynes has authored or co-authored numerous scientific articles, abstracts, book chapters, books, and patents. He is a member of a number of scientific and industry organizations. He has spoken and served as session chair at meetings of these organizations on numerous occasions. Dr. Hynes earned his bachelor's degree in psychology from Providence College and his Ph.D. in pharmacology and toxicology from the University of Rhode Island. After completing a post-doctoral fellowship at the Roche Institute of Molecular Biology, he joined Lilly Research Labs. He has held several management positions, including Director of Pharmaceutical Project Management, Director of Quality Assurance, and Director for Clinical Research for Eli Lilly, Japan.

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology