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DTSTAMP:20260503T130633Z
SUMMARY:Risk Management for Medical Devices - ISO 14971 - Webinar by G
 lobalCompliancePanel
DESCRIPTION:Overview:\nThis course provides the attendees with an over
 view of ISO 14971:2007 and implementation tips for an effective system
  for managing risk. We provide an overview using flow charts that show
 s each of the elements of a Risk Management system and how they fit to
 gether. This approach helps the participant understand the essential s
 tructure and the required elements. We look at the elements of Risk M
 anagement, including the required documents. This includes:\nA Risk Ma
 nagement Plan\nRisk Evaluation documentation\nRisk verification activi
 ties\nRisk Management Report\nRisk Management File\nObtaining producti
 on information\nLinking complaints to provide post-production informat
 ion\n\nYou will learn when written procedures are required, when (and 
 how) to name designated individuals, when (and how) to formally design
 ate units, and the records you must keep. \nWhy should you attend:\nD
 o you have a documented method to combine frequency and severity to ca
 lculate risk?\nDo have a formally approved Risk Management Plan that a
 pplies to your medical device?\nDo you apply risk reduction methods in
  the correct order?\nHave you documented the risk verification in the 
 Risk Management Report?\nDoes your manufacturing process control, espe
 cially validated processes, regularly update you Risk Management File?
 \n\nAreas Covered in the Session:\n\nAn overview of ISO 14971 to place
  the presentation in context\nFDA requirements for risk analysis as pa
 rt of design validation\nRecognition status of ISO 14971 by the FDA an
 d for the EU MDD and IVDD\nThe GHTF guidance document on risk manageme
 nt principles\nDeveloping a Risk Evaluation Matrix for your product\nF
 ailure Modes and Effects Analysis (FMEA)\nFault Tree Analysis (FTA)\n\
 nWho Will Benefit:\n\nValidation professionals\nDesign Engineers\nProj
 ect Managers involved in Design and Development\nQuality Engineers ass
 igned to validation activities\nQuality Auditors\nManagers\nQuality st
 aff assigned to Customer Complaints or CAPA management\n\n\n\n\nDan i
 s the President of Ombu Enterprises, LLC, a company offering training 
 and execution in Operational Excellence, focused on analytic skills an
 d a systems approach to operations management. Dan has more than 30 ye
 ars experience in quality, operations, and program management in regul
 ated industries including aviation, defense, medical devices, and clin
 ical labs. \n\nQuick Contact:\nGlobalCompliancePanel USA Phone:800-44
 7-9407webinars@globalcompliancepanel.comhttp://www.globalcompliancepan
 el.comEvent Link - http://bit.ly/1k271vO\n\n\n\n\n\nFor more informat
 ion visit https://medtechiq.ning.com/events/risk-management-for-medica
 l-devices-iso-14971-webinar-by
DTSTART;TZID=America/New_York:20140320T100000
DTEND;TZID=America/New_York:20140320T111500
CATEGORIES:webinar, pharma, medical, clinical, health
LOCATION:Online Event
WEBSITE:http://bit.ly/1k271vO
URL:http://bit.ly/1k271vO
CONTACT:8004479407
ORGANIZER;CN="John Robinson":https://medtechiq.ning.com/profile/JohnRo
 binson
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012189?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
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