Webinars > All COMPLIANCE Categories > Compliance Courses Webinars

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

 
Search similar training
Email this page
Print this document
 

Webinar Details

This date could not be found.


see all dates

 

Frequently Asked
Questions

Payment Options
Bill Me/Invoice
Credit Card

Register
Online
Fax Form

Availability
Select a date from the list at the bottom of the page for specific information about that class.

Other Information
Virtual Classroom (Live)

All Date/Location Information