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Preparing for FDA Pre-Approval Inspections - Hynes, Martin D.
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Hynes, Martin D.:

Preparing for FDA Pre-Approval Inspections - new book

ISBN: 9780849391842

ID: 1405540

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 21 st 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. Technology Technology eBook, CRC Press

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Pharmaceutical Pre-Approval Inspections A Guide to Regulatory Success 2nd Edition - Martin D. Hynes
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Martin D. Hynes:

Pharmaceutical Pre-Approval Inspections A Guide to Regulatory Success 2nd Edition - new book

ISBN: 9780849391842

ID: 9780849391842

Pharmaceutical Pre-Approval Inspections A Guide to Regulatory Success 2nd Edition Author :Martin D. Hynes 9780849391842 0849391849, [PU: CRC Press]

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Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences) - Martin D. Hynes (Editor)
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Martin D. Hynes (Editor):
Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences) - hardcover

ISBN: 0849391849

ID: 11800570541

[EAN: 9780849391842], Neubuch, [PU: CRC Press]

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Preparing for FDA Pre-Approval Inspections - Martin D. Hynes
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Martin D. Hynes:
Preparing for FDA Pre-Approval Inspections - hardcover

2008, ISBN: 0849391849

ID: 10552321594

[EAN: 9780849391842], Neubuch, [PU: CRC Press], New Book. Shipped from US within 10 to 14 business days. Established seller since 2000.

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Pharmaceutical Pre-Approval Inspections
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Pharmaceutical Pre-Approval Inspections - hardcover

ISBN: 9780849391842

ID: 501439634

Taylor & Francis Group . hardcover. New. pp. 304 2nd Edition, Taylor & Francis Group

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Details of the book
Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success
Author:

Martin D. Hynes (Editor), Hynes III Martin D, Hynes III Hynes III

Title:

Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success

ISBN:

9780849391842

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

Details of the book - Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success


EAN (ISBN-13): 9780849391842
ISBN (ISBN-10): 0849391849
Hardcover
Publishing year: 2008
Publisher: Informa Healthcare
278 Pages
Weight: 0,540 kg
Language: eng/Englisch

Book in our database since 22.11.2010 17:05:45
Book found last time on 03.10.2016 01:29:19
ISBN/EAN: 9780849391842

ISBN - alternate spelling:
0-8493-9184-9, 978-0-8493-9184-2

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