Monday 15 July 2013

Pharmaceutical Regulatory Inspections - A Practical Guide

A new book of interest has been published. The book it titled 'Pharmaceutical Regulatory Inspections - A Practical Guide'.

The book provides a framework, coupled with in-depth analysis, of current issues pertaining to international pharmaceutical regulatory inspections. The book contains 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.

The chapters are:

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

The book has been edited by Madhu Raju Saghee.

The book has been published by Euromed Communication, for details see: Pharma Book.

Posted by Tim Sandle

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