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UID:2140535:Event:469629
DTSTAMP:20260524T062643Z
SUMMARY:21 CFR Part 11, Data Integrity, and Computer System Validation
DESCRIPTION:Through a wide variety of regulations, standards, and guid
 ance, the U.S. FDA and other global regulatory competent authorities a
 re increasingly focused on software used for numerous regulated purpos
 es. Such uses include the management and analysis of clinical studies,
  product development, manufacturing, and the automation of Quality Sys
 tem elements such as complaint management, CAPA, management review, ri
 sk management, and document control. Each system within this scope mus
 t have evidence it was validated for its intended use.\nWith the dual 
 purpose of ensuring regulated software contributes to product safety a
 nd efficacy and of improving organizational compliance, regulatory aut
 horities face not only the ubiquitous incorporation of these systems b
 ut increasingly complex technical environments. From their point of vi
 ew, companies using software for regulated purposes also see a rapidly
  evolving technical landscape and a maturing regulatory environment, w
 ith increased technical competence on the part of interested third par
 ties. The confluence of these two perspectives places burden on both p
 arties to “up their game” in terms of relevant regulatory framewor
 ks, process discipline, and technical ability.\nLearning Objectives:\n
 \nUnderstand the difference between regulated and unregulated software
  in life sciences industries\nIdentify the major global regulatory doc
 uments governing regulated software\nBecome familiar with basic terms 
 associated with regulated software and how they may differ from terms 
 in other industries\nUnderstand the objectives of global regulatory bo
 dies in their oversight of regulated software\nUnderstand the activiti
 es and elements of various regulated software lifecycle models\nIdenti
 fy required and recommended documentation to ensure defensible evidenc
 e of validation for intended use\nUnderstand how to do effective impac
 t analysis of changes to the software system\nUnderstand the obligatio
 ns of firms using software developed by third parties\nUnderstand the 
 obligations of firms using software hosted by third parties\nUnderstan
 d the importance of confidentiality, integrity, and availability (i.e.
  CIA) in the software lifecycle\nUnderstand the importance of 21 CFR P
 art 11 to the software lifecycle and why it is often mistaken for the 
 sum total of validation requirements\n\nWho will benefit:\n\nRegulator
 y Affairs Staff\nQuality Assurance Staff\nManagers\nDirectors\nVPs\nIT
  Managers\nManufacturing Managers\nClinical Affairs Staff\nSoftware Ve
 ndors and Suppliers\n\n\nFor more information visit https://medtechiq.
 ning.com/events/21-cfr-part-11-data-integrity-and-computer-system-vali
 dation
DTSTART;TZID=America/New_York:20210928T083000
DTEND;TZID=America/New_York:20210929T163000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/fda-21-cfr-part-11-data-inegr
 ity-csv-seminar-training-80611SEM-prdsm?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/fda-21-cfr-part-11-data-inegrity-
 csv-seminar-training-80611SEM-prdsm?channel=MedTech%20I.Q
CONTACT:8887172436
ORGANIZER:Complianceonline
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/9459030495?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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