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