MASTER
 
 

Audit Trail [Generation] and Review 2019

By Compliance4all (other events)

Tuesday, January 8 2019 10:00 AM 11:30 AM
 
ABOUT ABOUT

Overview:
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.

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

Who Will Benefit:
Quality Managers
Quality Engineers
Small Business Owners
GxP
Consultants
Quality VPs
IT VPs
FDA 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.

Event Fee: One Dial-in One Attendee Price: US $150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]