Pharmaceutical Regulatory Inspections

ISBN 978-1-899015-89-4

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L ICA T CEUY A RM TOR S A PH GULATION STORY – N" RE PEC A SUCCEKSES IT HAPPE A N INS OM CTIO
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Price £395 £355 Pre-publication price – valid until
31 Jan 2013
Printed or online version For a corporate licence, please contact publisher

Plus carriage (for printed copy) UK £10, Europe £15, RoW £20

MAKE EVERY INSPECTION A SUCCESS STORY A PRACTICAL GUIDE TO MAKE IT HAPPEN

Contents
Pharmaceutical Regulatory Inspections a practical guide
Editor: Madhu Raju Saghee
1. Basic Concepts of Global GMP Requirements by Tim Sandle & Madhu Raju Saghee 2. FDA Drug Regulation and Enforcement by Seth Mailhot 3. System Based Approach to Inspections by David Barr & Tim Sandle 4. Preparing for Preapproval Inspections by Ron Johnson 5. Effectively Managing and Surviving FDA Inspections by John Avellanet 6. Guide for Successful EU Inspection Management by Siegfried Schmitt & Nabila Nazir 7. Regulatory Requirements of Japanese GMP Inspections by Yoshikazu Hayashi 8. Preparing and Management of International Inspections by Andreas Brutsche & Tim Sandle 9. Handling and Responding to Post inspectional Observations by Tim Sandle, Madhu Raju Saghee & David Barr 10. Preparing for Regulatory Inspections of Sterile Facilities: The Focal Points by Tim Sandle 11. Preparing for Regulatory Inspections of API Facilities: The Focal Points by Siegfried Schmitt & Richard Einig 12. Optimizing your Regulatory Compliance by Mark Tucker

Contains a practical advice and insight to help different types of pharmaceutical organisations prepare for GMP inspections, understand key regulatory issues and review inspectorate trends and findings.

No other book captures such a diverse range of experts to provide a focussed account of regulatory issues from preapproval inspections, the inspection itself to postinspection and maintaining compliance.

Expert advice
This is a unique book in which agency inspectors express their views and provide tips for succeeding in regulatory inspections.

International
The book compares inspection by the major regulatory agencies, the FDA, EU and Japan, as well as international inspections.

Editor:
Madhu Raju Saghee
Published by:

Make every inspection a success story

Passfield Business Centre, Lynchborough Road, Passfield,Hampshire GU30 7SB Tel: 44 (0) 1428 752222 Fax: +44 (0) 1428 752223

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