BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T021326Z UID:272a3fcc-bdf3-4be3-9638-8ac05ab941d8 DTSTART:20210820T110000 DTEND:20210821T110000 CLASS:PRIVATE DESCRIPTION:
Why should you attend
\n\nThe attende
e will learn how to comply with FDA'\;s 21 CFR Part 11 guidance\, which
addresses the use of electronic records and electronic signatures (ER/ES)
. There are specific security and authentication requirements that are not
necessarily covered by the standard computer system validation (CSV) appr
oach\, and go somewhat beyond this.
\nWe will also address the roles
of people involved in validating and supporting the systems\, aside from j
ust the standard system users. There are many tasks and functions they nee
d to understand in order to be in compliance.
Wh o will benefit
\n\nProfessionals in the following industrie
s may also benefit from the content:
\n&bull\; Pharmaceutical
\n
&bull\; Medical Diagnostics
\n&bull\; Biotechnology
\n&bull\; To
bacco and Related (Vapor\, e-Cigarette\, Cigar\, etc.)
\n&bull\; Anim
al Health
\nAny other FDA-regulated industry\, plus any Life Science
Consulting or Contracting firm
\n&bull\; Information technology manag
ers and analysts
\n&bull\; Production managers and analysts
\n&b
ull\; QC/QA managers and analysts
\n&bull\; Clinical data managers an
d scientists
\n&bull\; Compliance managers
\n&bull\; Lab manager
s and staff
\n&bull\; Automation analysts
\n&bull\; Computer sys
tem validation specialists
\n&bull\; GMP training specialists
\n
&bull\; Business stakeholders and individuals who are responsible for comp
uter system validation planning\, execution\, reporting\, compliance\, tra
ining and audit
\n&bull\; Consultants working in the life sciences\,
tobacco and related industries who are involved in computer system impleme
ntation\, validation and compliance