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Compliance 4 All
Compliance 4 All presents

Virtual Classroom (Live) 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

Who Will Benefit:
  • GxP
  • Consultants
  • Quality VPs
  • IT VPs
  • FDA Investigators
  • 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. 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
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) Virtual Classroom (Live)

Who Should Attend

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

 
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Webinar Details

8/28/2019 - 8/28/2019
Tuition: $150

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Other Information
Virtual Classroom (Live)

All Date/Location Information

8/28/2019-8/28/2019 at 10:00:00 AM PDT