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DTSTART:19700308T020000
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UID:2140535:Event:80194
DTSTAMP:20260415T132610Z
SUMMARY:Webinar On \"Computer System Validation\"
DESCRIPTION:\nDescription :\nFDA requires that all software in compute
 r systems used in GxP activities must be validated. Validation of comp
 uter system software is completely different than validation of device
  software (embedded software). Validation is more than testing. It is 
 testing plus design control and configuration management. How to plan 
 and conduct a risk based validation will be explained. Overall risk fo
 r computer system is a combination of software complexity and product 
 risk as determined by probability, severity and detectability rankings
 . Also involved in the risk evaluation is the requirement for purchase
 d software supplier qualification. You’ll learn how to integrate ris
 k based supplier evaluation into the validation process. Validation Ma
 ster plan and System Validation Plans will be explained Testing, based
  on risk, includes requirements validation and IQ, OQ and PQ. A proced
 ure for each level of complexity and risk will be described.\n\n\n\n\n
 Areas Covered in the Session :\n\nValidation strategy\nRequirements do
 cumentation\nComplexity and risk analysis\nCreating a detailed test pl
 an based on risk\nSupplier qualification\nIQ, OQ and PQ\n\n\n\n\n\n\nW
 ho Will Benefit:\n\nComputer system developers\nSystems development en
 gineers\nQA/ QC\nLab Managers and Analysts\nProduction Managers\nEngin
 eering managers\n\n\n\n\n\n\nAbout Speaker:\nEdwin Waldbusser retired 
 from industry after 20 years in management of development of medical d
 evice products and development of company Quality Systems. Products in
 cluded IVD devices, kidney dialysis systems and inhalation devices. QS
  experience includes design control, risk analysis, CAPA, software val
 idation, supplier qualification/ control and manufacturing/ non-confor
 ming product programs. Edwin Waldbusser has a B.S. Mechanical Engineer
 ing from NYU and a M.B.A from Drexel University. He is certified by Ll
 oyds of London as an ISO 9000 Lead Auditor and is a member of the Thom
 son Reuters Expert Witness network. He has 5 issued patents.\n\n\n\n\n
 \n\nFor more information visit https://medtechiq.ning.com/events/webin
 ar-on-computer-system-validation-3
DTSTART;TZID=America/New_York:20180919T130000
DTEND;TZID=America/New_York:20180919T140000
CATEGORIES:online, "/", webinar
LOCATION:Online
WEBSITE:https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MD001
 11
URL:https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MD00111
CONTACT:1-844-216-5230
ORGANIZER;CN="Sam Miller":https://medtechiq.ning.com/profile/SamMiller
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562019029?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Sam Mill
 er":https://medtechiq.ning.com/profile/SamMiller
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