Introduction

On July 8, 2010, the FDA announced to soon conduct a series of inspections related to 21 CFR Part 11. FDA made it very clear that the focus of the inspections will on most critical issues the industry had with Part 11 in the past. The best way to find out what the issues are is to look at recent FDA 483 form inspectional observations and warning letters related to computer system validation and Part 11 compliance. Just from 2007-2010, there have already been more than 30 such warning letters, some with disastrous consequences for inspected companies. This seminar will give an overview of FDA inspection findings and recommendations on how to avoid them.

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Venue

Online Training Webinar

Online Training Webinar, United States

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Organised by

GlobalCompliancePanel

Contact information

Mr Manzoor
United States of America
800-447-9407
Contact us by email

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