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DTSTAMP:20260525T210601Z
SUMMARY:Computer System Validation 2018 Fundamentals
DESCRIPTION:Overview:FDA requires that all software in computer system
 s used in GxP activities must be validated. Validation of computer sys
 tem software is completely different than validation of device softwar
 e (embedded software). Validation is more than testing. It is testing 
 plus design control and configuration management.\nWhy should you Atte
 nd:Validation of computer system software is completely different than
  validation of device software (embedded software). Attempting to cond
 uct a CSV following device software validation concepts could result i
 n a 483 or rejection of a product approval submission.\nAreas Covered 
 in the Session:Validation strategyRequirements documentationComplexity
  and risk analysisCreating a detailed test plan based on riskSupplier 
 qualificationIQ, OQ and PQ\nWho Will Benefit:Computer System Developer
 sSystems Development EngineersQA/ QCLab Managers and AnalystsProductio
 n ManagersEngineering Managers\nSpeaker Profile:Edwin Waldbusser is a 
 consultant retired from industry after 20 years in management of devel
 opment of medical devices (5 patents). He has been consulting in the U
 S and internationally in the areas of design control, risk analysis an
 d software validation for the past 8 years. Mr. Waldbusser has a BS in
  Mechanical Engineering and an MBA. He is a Lloyds of London certified
  ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witn
 ess network.\nEvent Fee: One Dial-in One Attendee Price: US$150.00\nCo
 ntact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email
 : support@compliance4All.com\n\nFor more information visit https://med
 techiq.ning.com/events/computer-system-validation-2018-fundamentals
DTSTART;TZID=America/New_York:20181023T100000
DTEND;TZID=America/New_York:20181023T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://www.compliance4all.com/control/w_product/~product_id=5
 02115LIVE?channel=medtechiq_Oct_2018_SEO
URL:https://www.compliance4all.com/control/w_product/~product_id=50211
 5LIVE?channel=medtechiq_Oct_2018_SEO
CONTACT:Event Manager
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562025446?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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