BEGIN:VCALENDAR
PRODID:NingEventWidget-v1
VERSION:2.0
METHOD:PUBLISH
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
UID:2140535:Event:65312
DTSTAMP:20260907T083926Z
SUMMARY:Webinar On Medical OEM Design Control Audit: Expectations
DESCRIPTION:Description :\nThis 60 minute webinar on a Design Control 
 Audit by the FDA and other bodies will provide an understanding of wha
 t a medical OEM should anticipate during an audit during a design cont
 rol audit. All medical device companies that are in need of examining 
 their design control process should be aware of what to expect.\nAreas
  Covered in the Session :\nChampion/Multi-functional team approach/res
 ponsibility\nDealing with the FDA and other authorizing bodies\nPhase 
 by phase design process check list\nDesign input/output\nDesign verifi
 cation/validation\nDesign changes\nDesign review\nDesign History File 
 (DHF)\nDue-diligence\nGap analysis – data gathering for the design h
 istory files\nRisk assessment\nDesign changes\n483 warning letters\nPl
 anning to be prepared\nWho Will Benefit:\nThis webinar will provide va
 luable assistance and give a process to all medical device and regulat
 ed companies that need to prepare for an FDA or authorizing bodies aud
 it in the future. The employees who will benefit include:\nOEM and CMO
  quality managers\nOEM and CMO quality engineers\nEnd-users responsibl
 e for design control and technical files\nR&D and product development\
 nProcess engineers and managers\nOperations and plant management\nVali
 dation engineers\nRemediation teams\nQA, Regulatory Affairs\nQC and Co
 rporate Auditors\nAll team members who contribute to design history fi
 les, clinical, verifications/validations, risk management or technical
  files\nConsultants\nProject managers\nSupplier management\nProduct tr
 ansfer engineers\nAll Contract Manufacturers working in the medical in
 dustry\nPrice Tags:\nLive\nSingle Live : For One Participant\n$ 249\nC
 orporate Live : For Max. 10 Participants\n$ 899\nRecording\nSingle REC
  : For One Participant - Unlimited Access for 6 Months\n$ 299\nFor mor
 e information and enquiries contact us at\nCompliance Trainings\n5939 
 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support :
  #416-915-4458  Email : support@compliancetrainings.com\nFor more in
 formation about this event please visit\nhttps://compliancetrainings.c
 om/SiteEngine/ProductDetailView.aspx?id=MD1187\nLike Us On facebook:\n
 https://www.facebook.com/events/724301417677871/?source=1&sid_create=3
 300179455\n\nFor more information visit https://medtechiq.ning.com/eve
 nts/webinar-on-medical-oem-design-control-audit-expectations
DTSTART;TZID=America/New_York:20150226T130000
DTEND;TZID=America/New_York:20150226T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=MD1187
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=MD1187
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011850?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
END:VEVENT
END:VCALENDAR