Electronic Records: Effective Approaches that Reduce Costs (21 CFR Part 11)

Venue: The Hilton San Diego Resort & Spa

Location: San Diego, California, United States

Event Date/Time: Mar 24, 2011 End Date/Time: Mar 24, 2011
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Description

The instructor addresses the latest computer system industry standards for data security, data transfer, and audit trails. Attendees will see how 21 CFR Part 11, the FDA regulation pertaining to use of electronic records and signatures, and the HIPAA electronic security regulations for patient medical records fit into the validation process. Finally, the instructor will review recent FDA inspection trends and discusses how to streamline SOP authoring, revision, review, and approval.

Venue

1775 East Mission Bay Drive
San Diego
California
United States
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