Updated Audit Trail Generation and Review

Overview:

This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

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 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:

• Quality Managers
• Quality Engineers
• Small Business Owners
• GxP
• Consultants
• Quality VPs
• IT VPs
• FDA Investigators
• Other Regulatory Agency 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. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital.