Preparing for FDA Pre-Approval Inspections

A Guide to Regulatory Success, Second Edition
Herausgeber: Hynes, Martin D

• Broschiertes Buch

Produktbeschreibung

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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Produktdetails

• Verlag: Taylor & Francis Ltd (Sales)
• 2nd edition
• Seitenzahl: 304
• Erscheinungstermin: 2. Dezember 2019
• Englisch
• Abmessung: 229mm x 152mm x 16mm
• Gewicht: 404g
• ISBN-13: 9780367452711
• ISBN-10: 0367452715
• Artikelnr.: 58441656

Autorenporträt

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.

Inhaltsangabe

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.