Preparing for FDA Pre Approval Inspections A Guide to Regulatory Success 2nd Edition by ISBN Martin D HynesBN 0849391849 978-0849391842

Preparing for FDA Pre Approval Inspections A Guide to Regulatory Success 2nd Edition by Martin D.Hynes – Ebook PDF Instant Download/Delivery:0849391849 ,978-0849391842 
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Product details: 

ISBN 10:0849391849

ISBN 13:978-0849391842 

Author:Martin D.Hynes

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

Table of contents: 

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.

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Tags: Martin D Hynes, Preparing, Inspections