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DTSTART:19700308T020000
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UID:2140535:Event:78678
DTSTAMP:20260522T132609Z
SUMMARY:Practices to Support FDA Computer System Validation
DESCRIPTION:Overview:We will cover the importance of maintaining the d
 ocumentation from every computer system validation effort in a \"curre
 nt\" state. The system must be maintained in a validated state through
 out its entire life cycle, and the accompanying validation documentati
 on must also be maintained.\nWhy should you Attend:This session will a
 ddress the specific way of documenting your computer system validation
  work to ensure it meets FDA requirements and can pass an inspection. 
 There are specific requirements that must be followed in order for the
  Agency to consider the documentation valid, and without following the
 se, there is a great risk of invalidating work.\nAreas Covered in the 
 Session:Computer System Validation (CSV) and the System Development Li
 fe Cycle (SDLC) Methodology\"GxP\" - Good Manufacturing, Laboratory an
 d Clinical Practices21 CFR Part 11, Electronic Records/Electronic Sign
 atures (ER/ES)Data Archival to ensure security, integrity and complian
 ce\nWho Will Benefit:Information Technology AnalystsInformation Techno
 logy Developers and TestersQC/QA Managers and AnalystsAnalytical Chemi
 stsLaboratory ManagersAutomation Analysts\nSpeaker Profile:Carolyn (Mc
 Killop) Troiano has more than 35 years of experience in the tobacco, p
 harmaceutical, medical device and other FDA-regulated industries. She 
 has worked directly, or on a consulting basis, for many of the larger 
 pharmaceutical and tobacco companies in the US and Europe, developing 
 and executing compliance strategies and programs.\nEvent Fee: One Dial
 -in One Attendee Price: US$150.00\nContact Detail:Compliance4All DBA N
 etZealous,Phone: +1-800-447-9407Email: support@compliance4All.com\n\nF
 or more information visit https://medtechiq.ning.com/events/practices-
 to-support-fda-computer-system-validation
DTSTART;TZID=America/New_York:20180501T010000
DTEND;TZID=America/New_York:20180501T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1782LIVE?channel=medtechiq_May_2018_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501782
 LIVE?channel=medtechiq_May_2018_SEO
CONTACT:18004479407
ORGANIZER:Event Manager
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562017373?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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