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DTSTAMP:20240329T073124Z
UID:33292c32-8602-4aaf-a489-83fc98b3ad85
DTSTART:20210405T100000
DTEND:20210406T100000
CLASS:PRIVATE
DESCRIPTION:Overview:
\nThese electronic records must be maintained ac
cording to regulatory
\nrequirements contained within FDA'\;s 21 C
FR Part 11 for US
\njurisdictions and Eudralex Volume 4 Annex 11 for
EU jurisdictions.
\n
\nWhy should you Attend:
\nAttendees w
ill learn how to review audit trails\, using a risk based
\napproach
to cull through the thousands of audit trail records that can
\nbe ge
nerated on a daily basis.
\n
\nAreas Covered in the Session:
\nWhat is an Audit Trail
\n21 CFR 11 / Annex 11 requirements for Au
dit Trails
\nWhy Audit Trails
\nWhat are Audit Trail Features
\nWhat are Audit Trail Contents
\nWhat records need to have an Aud
it Trail
\nWhen does Audit Trail begin
\n
\nWho Will Benefi
t:
\nGxP
\nConsultants
\nQuality VPs
\nIT VPs
\nF
DA Investigators
\nOther Regulatory Agency Investigators
\n
\nSpeaker Profile:
\nAngela Bazigos is the CEO of Touchstone Technol
ogies Inc. She has
\ndegrees in Microbiology and Computing and 40 yea
rs of experience
\nin the Life Sciences\, Healthcare &\; Public He
alth Services. \;
\nExperience combines Quality Assurance\, Regul
atory Compliance\,
\nBusiness Administration\, Information Technology
\, Project
\nManagement\, Clinical Lab Science\, Microbiology\, Food
Safety &\;
\nTurnarounds.
\n
\nEvent Fee: One Dial-in On
e Attendee Price: US $150.00
\n
\nContact Detail:
\nComplia
nce4All DBA NetZealous\,
\nPhone: +1-800-447-9407
\nEmail: compl
iance4all14@gmail.com
SUMMARY:Audit Trail Generation and Review 2021
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SUMMARY:Audit Trail Generation and Review 2021
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