Auditing Systems for 21 CFR Part 11 Compliance Preparing Yourself for Inspection
Why Should You Attend:
Can you show me how you manage your computer systems in compliance with 21CFR Part 11?
This presentation will describe a process which has prepared several companies to answer this question from FDA inspectors accurately, completely and to the great satisfaction of the inspectors. We will show how to inventory the site, assess the compliance risk of existing systems, implement new systems, remediate any non-compliance found, prepare SOPs and quality policies, collate the required documentation and train the staff.
Date: May 21, 2013
Time: 10:00 AM-11:30 AM PDT
Cost: $299 per attendee per computer terminal
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