Audit Trail Generation and Review 2019

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Category Audit Trail, Electronic Records, 21 CFR Part 11 Courses, audit trail salesforce, audit trail requirements, Small Business Owners, Compliance trainings, Online audit courses

Deadline: April 02, 2019 | Date: April 03, 2019

Venue/Country: Online, U.S.A

Updated: 2019-02-18 15:28:28 (GMT+9)

Call For Papers - CFP

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: compliance4all14gmail.com