Audit Trail Generation and Review 2019

Overview: These electronic records must be maintained according to regulatory requirements contained within FDAs 21 CFR Part 11 for US jurisdictions and

Event Detail

    Description :
    Overview: These electronic records must be maintained according to regulatory requirements contained within FDAs 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: compliance4all14@gmail.com
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    When

      Date :
    • 04/03/2019
    • Start Day :
    • Wednesday
    • Time :
    • 10:00AM

    Where

      Location :
    • Fremont, California, United States
    • Address :
    • Fremont, California, United States
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    • Fremont,California-
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