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TZID:America/New_York
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DTSTART:19700308T020000
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BEGIN:VEVENT
UID:2140535:Event:74779
DTSTAMP:20260520T060530Z
SUMMARY:Compliance for Computer Systems Regulated by FDA - 2017
DESCRIPTION:Overview:The Webinar will focus on the importance of ensur
 ing that electronic record/electronic signature (ER/ES) capability bui
 lt into FDA-regulated computer systems meets compliance with 21 CFR Pa
 rt 11. This includes development of a company philosophy and approach,
  and incorporating it into the overall computer system validation prog
 ram and plans for individual systems that have this capability.\nWhy s
 hould you Attend:This Webinar will help you understand in detail the a
 pplication of FDA's 21 CFR Part 11 guidance on electronic records/elec
 tronic signatures (ER/ES) for computer systems subject to FDA regulati
 ons.\nAreas Covered in the Session:Validation StrategySystem Risk Asse
 ssmentGAMP 5 \"V\" Model21 CFR Part 11Electronic Records/Electronic Si
 gnatures (ER/ES)Security, Access, Change Control and Audit Trail\nWho 
 Will Benefit:Clinical Data Managers and ScientistsAnalytical ChemistsL
 aboratory ManagersAutomation AnalystsManufacturing and Supply Chain Ma
 nagers and AnalystsComputer System Validation Specialists\nSpeaker Pro
 file:Carolyn (McKillop) Troiano Carolyn Troiano has more than 35 years
  of experience in the tobacco, pharmaceutical, medical device and othe
 r FDA-regulated industries. She has worked directly, or on a consultin
 g basis, for many of the larger pharmaceutical and tobacco companies i
 n the US and Europe, developing and executing compliance strategies an
 d programs.\nContact Detail:Compliance4All DBA NetZealous,Phone: +1-80
 0-447-9407Email: support@compliance4All.com\n\nFor more information vi
 sit https://medtechiq.ning.com/events/compliance-for-computer-systems-
 regulated-by-fda-2017
DTSTART;TZID=America/New_York:20171010T100000
DTEND;TZID=America/New_York:20171010T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1506LIVE?channel=medtechiq_Oct_2017_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501506
 LIVE?channel=medtechiq_Oct_2017_SEO
CONTACT:18004479407
ORGANIZER:Event Manager
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562037429?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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