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These electronic records must be maintained according to regulatory requirements contained within FDA's 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions.
Why should you Attend:
Attendees will learn how to review audit trails, using a risk based approach to cull through the thousands of audit trail records that can be generated on a daily basis.
Areas Covered in the Session:
What is an Audit Trail
21 CFR 11 / Annex 11 requirements for Audit Trails
Why Audit Trails
What are Audit Trail Features
What are Audit Trail Contents
What records need to have an Audit Trail
When does Audit Trail begin
Who Will Benefit:
Other Regulatory Agency Investigators
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.
Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds.
Event Fee: One Dial-in One Attendee Price: US $150.00