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UID:2140535:Event:80803
DTSTAMP:20260904T190051Z
SUMMARY:Webinar On \"Medical Device Complaints & CAPA\"
DESCRIPTION:\nDescription :\nThis webinar will explain the CAPA proces
 s from information gathering through MDR and Recall decision making to
  final CAPA closing. Post closing effectiveness evaluation is required
  and will be explained. Preventative Action is often neglected and wil
 l be discussed. Post distribution product monitoring including custome
 r surveys will be explained. Integration of manufacturing non conforma
 ties with the CAPA program will be discussed.\n\n\n\n\n\nAreas Covered
  in the Session :\nCAPA phases to be discussed\nSources of information
  (complaints)\nInformation gathering & proactive information gathering
 \nInformation evaluation (is it a Complaint, is it a CAPA, should it b
 e investigated)\nRisk analysis applied to CAPA\nRoot cause determinati
 on\nCAPA Investigation Report & CAPA action Plan\nVerification/ Valida
 tion of CAPA action\nPost closing effectiveness check\nCAPA program me
 trics\n\n\n\n\n\nWho Will Benefit:\n\nMedical device engineering\nRegu
 latory\nQuality Assurance\nManagement\n\n\n\n\n\nAbout Speaker:\nEdwin
  Waldbusser retired from industry after 20 years in management of deve
 lopment of medical device products and development of company Quality 
 Systems. Products included IVD devices, kidney dialysis systems and in
 halation devices. QS experience includes design control, risk analysis
 , CAPA, software validation, supplier qualification/ control and manuf
 acturing/ non-conforming product programs. Edwin Waldbusser has a B.S.
  Mechanical Engineering from NYU and a M.B.A from Drexel University. H
 e is certified by Lloyds of London as an ISO 9000 Lead Auditor and is 
 a member of the Thomson Reuters Expert Witness network. He has 5 issue
 d patents.\n\n\n\n\n\n\nFor more information visit https://medtechiq.n
 ing.com/events/webinar-on-medical-device-complaints-amp-capa
DTSTART;TZID=America/New_York:20181018T130000
DTEND;TZID=America/New_York:20181018T140000
CATEGORIES:online, "/", webinar
LOCATION:Online
WEBSITE:https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MD001
 15
URL:https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MD00115
CONTACT:8442165230
ORGANIZER;CN="Sam Miller":https://medtechiq.ning.com/profile/SamMiller
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562019413?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Sam Mill
 er":https://medtechiq.ning.com/profile/SamMiller
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