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Audit Trail Generation and Review

Audit Trail Generation and Review

  Duration: 90 Minutes

Faculty: Angela Bazigos      Level: Intermediate      Course ID: 1177

Overview:

Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records.  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. One of the requirements for such compliance is the generation and review of audit trails. Thousands of audit trail records can be generated on a daily basis.

Why should you Attend:

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.

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:

  • 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:

  • Quality Managers
  • Quality Engineers
  • Small business owners
  • GxP Consultants
  • Quality VPs
  • IT VPs
  • FDA investigators
  • Other regulatory agency investigators
Recording
$179.00

Access Recording for Life Time

DVD
$199.00

Training DVD will be shipped within 10 business days

USB
$209.00

Training USB will be shipped within 10 business days

Group 5
$599.00

Get 5 Recording Licenses

Group 10
$749.00

Get 10 Recording Licenses

Sr. Life Science Consultant