Audit Trail Generation and Review

Overview: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:Additionally, 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 Trail21 CFR 11 / Annex 11 requirements for Audit TrailsWhy Audit TrailsWhat are Audit Trail FeaturesWhat are Audit Trail ContentsWhat records need to have an Audit Trail
Who Will Benefit:Quality ManagersQuality EngineersSmall Business OwnersGxPConsultantsQuality VPsIT VPsFDA Investigators
Speaker Profile: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
Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: compliance4all14@gmail.com