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San Francisco Professional Events List
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Audit Trail Generation and Review 2021
Date
Apr 05, 2021 - 10:00 AM
Link to Website
Organizer
Netzealous LLC DBA - Compliance4All
Venue
online
Location
161 Mission Falls Lane, Suite 216,,
Fremont,
California,
United States,
ZIP: 94539
Phone: 8004479407
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:
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
Who Will Benefit:
GxP
Consultants
Quality VPs
IT VPs
FDA Investigators
Other Regulatory Agency 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]
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:
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
Who Will Benefit:
GxP
Consultants
Quality VPs
IT VPs
FDA Investigators
Other Regulatory Agency 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]
Event Categories
Keywords: Educational, HealthCare , pharmaceutical , medical