Effective Implementation of Audit Programs provides current perspectives on informal and formal audits.

Written by Miguel Montalvo, who has more than 32 years of extensive experience in the areas of cGMP compliance, quality operations/systems and validation functions/responsibilities, this book applies recent developments and perspectives from regulators and industry experts.

This well-researched text is a must have for personnel involved in the implementation and execution of critical programs, auditors, auditees and outsourcing providers!

Table of Contents:

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Introduction

1. The Informal Audit Program — "Self-Inspections" and "Area Walk-Through"
2. The Formal Internal Audit Program
3. Key Aspects to Audit in Particular Systems/Areas
4. Outsourcing Management and The External Audit Program
5. Final Conclusions and Recommendations

About the Author

Miguel Montalvo, has more than 32 years of extensive experience in the areas of cGMP compliance, quality operations/systems and validation functions/responsibilities. He has been a frequent speaker/chairman/instructor at hundreds of compliance, validation and quality related conferences and courses around the world for such groups as PDA, PTi, CfPIE, IVT, Barnett International and the CTFA. Mr. Montalvo's articles and papers have been published in the American Pharmaceutical Review and the Journal of Validation Technology, and he has also authored chapters in recognized industry reference books.