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DTSTAMP:20240329T141205Z
UID:97158941-07c6-48a2-b062-0b836a4a2e1b
DTSTART:20210108T100000
DTEND:20210109T100000
CLASS:PRIVATE
DESCRIPTION:Overview:
\nThese electronic records must be maintained ac
cording to regulatory requirements contained within FDA'\;s 21 CFR Part
11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictio
ns.
\n
\nWhy should you Attend:
\nAdditionally\, attendees
will learn how to review audit trails\, using a risk based approach to cul
l through the thousands of audit trail records that can be generated on a
daily basis.
\n
\nAreas Covered in the Session:
\nWhat is a
n Audit Trail
\n21 CFR 11 / Annex 11 requirements for Audit Trails
\nWhy Audit Trails
\nWhat are Audit Trail Features
\nWhat are
Audit Trail Contents
\nWhat records need to have an Audit Trail
\n
\nWho Will Benefit:
\nQuality Managers
\nQuality Engine
ers
\nSmall Business Owners
\nGxP
\nConsultants
\nQual
ity VPs
\nIT VPs
\nFDA Investigators
\n
\nSpeaker Prof
ile:
\nAngela Bazigos is the CEO of Touchstone Technologies Inc. She
has degrees in Microbiology and Computing and 40 years of experience in th
e Life Sciences\, Healthcare &\; Public Health Services. Experience com
bines Quality Assurance\, Regulatory Compliance\, Business Administration\
, Information Technology\, Project Management\, Clinical Lab Science\, Mic
robiology\, Food Safety &\; Turnarounds.
\n
\nEvent Fee: One
Dial-in One Attendee Price: US $150.00
\n
\nContact Detail:
\nCompliance4All DBA NetZealous\,
\nPhone: +1-800-447-9407
\nEm
ail: compliance4all14@gmail.com
SUMMARY:Audit Trail [Generation] and Review 2021
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SUMMARY:Audit Trail [Generation] and Review 2021
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