BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
X-WR-CALNAME:Demystifying 21 CFR Part 11 Compliance for REDCap
X-WR-TIMEZONE:Eastern Time (US & Canada)
BEGIN:VEVENT
DTSTAMP:20260616T094344Z
UID:tag:localist.com\,2008:EventInstance_49083918563241
DTSTART:20250407T160000Z
DTEND:20250407T170000Z
DESCRIPTION:Navigating 21 CFR Part 11 compliance is a crucial yet daunting 
 task for clinical researchers and regulatory professionals. This webinar\,
  part of an ongoing effort to enhance compliance understanding and impleme
 ntation\, aims to clarify FDA guidance on electronic records and digital s
 ignatures. Specifically tailored for researchers\, regulatory representati
 ves\, and software support staff at academic institutions\, this session w
 ill provide a comprehensive overview of the 21 CFR Part 11 requirements wi
 thin the context of the REDCap Electronic Data Capture System.\n\nAn NCATS
 -supported working group is developing a 21 CFR Part 11 Implementation Gui
 de for REDCap\, which will be introduced during the webinar. Attendees wil
 l learn practical steps for setting up a compliance program and configurin
 g a REDCap environment that meets FDA submission standards. Join us to gai
 n valuable insights and tools to ensure your clinical trials are compliant
 \, efficient\, and ready for regulatory submission. Theresa Baker\, Senior
  Application Analyst\, and  Alex Cheng\, Assistant Professor of Biomedical
  Informatics from Vanderbilt Univerity Medical Center will present.\n\n###
 \n\nThis event\,  hosted by the Trial Innovation Network\, is available to
  the University of Rochester community via the UR Clinical and Translation
 al Science Institute.
LOCATION:
SUMMARY:Demystifying 21 CFR Part 11 Compliance for REDCap
URL;VALUE=URI:https://events.rochester.edu/event/demystifying-21-cfr-part-1
 1-compliance-for-redcap
CATEGORIES:Lectures & Talks
END:VEVENT
END:VCALENDAR