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      Audit Trail Generation and Review 2019 in Fremont

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      April 3, 2019

      Wednesday  10:00 AM - 11:30 AM

      Fremont, California, United States
      Fremont, California

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      Audit Trail Generation and Review 2019

      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:
      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

      Cost: Payment required - One Dial-in One Attendee Price: $150.00

      Categories: Conferences & Tradeshows | Education | Health & Wellness

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.