FDA Inspections -What Regulators Expect and How to Prepare

Who Should Attend

This is a practical, hands-on course designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection. The course is ideal for Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance.

Learning Objectives

The course is designed to meet the objectives of preparing for – and surviving – an FDA inspection. Upon completion of the course you will:

Understand the guidelines, philosophy and practical approach of the FDA to inspections and visits
Understand the new FDA “systems approach” to inspections (QSIT), and the differences from the traditional “issues” approach
Develop strategies for preparing for and coping with FDA inspections
Plan for a self-audit in anticipation of FDA inspections
Have resources for reference and update

Course Description

This course is designed to provide participants with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical, biologics, and device facilities.

Additional benefits of this class include discussion of:

FDA authority and process including 483s, Warning Letters, recalls, and other potential actions
The FDA inspection process and approach
Device Master Records requirements
The use of a mock audit and outside certifying audit
Required documentation, format, and archive
How to respond to inspection and audit results
Parallel process from the EMEA, TGA, PMDA, and other international regulatory agencies
A chance to actively learn form fellow participants and well as from an instructor who brings 30 years of practical regulatory experience to a lively combination of lecture, discussion, and exercises

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12 Jun - 13 Jun 2012
Los Angeles
United States of America
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