Overview: In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject.
Validation and 21 CFR Part 11 Compliance of Computer Systems - US Seminar 2012 at San Francisco
3 - 4 May 2012, San Francisco, United States
Introduction
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San Francisco, Marriott Marquis Downtown
San Francisco, Marriott Marquis Downtown, San Francisco, United States
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GlobalCompliancePanel
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