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Compliance 4 All presents

 Audit Trail Generation and Review  Webinar

In this webinar 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.

Course Description/Agenda

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: 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
• What clock should be used for the timestamp
• How is Audit Trail versioned
• How is Audit Trail stored
• What if my system does not have automated Audit Trail
• What about "hybrid" systems
• How to review audit trails
  • Risk Based Approach
  • Best Practices
• Audit Trail and Data Integrity

• GxP
• Consultants
• Quality VPs
• IT VPs
• FDA Investigators
• Other Regulatory Agency Investigators

Instructor:

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. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA.

 

More Webinar Information

Compliance 4 All Course Summary In this webinar 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. Delivery Method  Virtual Classroom (Live) Who Should Attend • GxP • Consultants • Quality VPs • IT VPs • FDA Investigators • Other Regulatory Agency Investigators

 

All Date/Location Information