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PRODID:-//github.com/rianjs/ical.net//NONSGML ical.net 4.0//EN
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DESCRIPTION:This two day interactive seminar will focus on:\n\n\nComplaint
  Management\nMedical Device Reporting (MDR)\nEU Vigilance Reporting\nProd
 uct Recalls\n\nThis course will provide practical guidance and real life 
 examples that will help you develop and/or optimize your company’s post m
 arket surveillance system.\n\nLearning Objectives :\nKey goal of this cou
 rse is to understand:\n\n\nLegal authorities (statutes and regulations) a
 nd definitions applicable to key elements of Post Market Surveillance (Co
 mplaint Management\, MDRs\, Vigilance and Product Recalls)\nRegulatory an
 d compliance requirements related to each element of Post Market Surveill
 ance (Complaint Management\, MDRs\, Vigilance and Product Recalls)\nImple
 menting applicable processes and procedures for Complaint Management\, MD
 Rs\, Vigilance and Product Recalls\nManagement review and dissemination o
 f Post Market Surveillance information\nWhat to do when a complaint is re
 ceived:\n\nWhat/how/when to investigate a complaint\nContents of records 
 of complaint investigation\nHow to adjudicate the complaint\nImplementing
  interactive systems between complaint handling\, medical device reportin
 g\, and CAPA\n\nSubmission of MDR’s to the FDA:\n\nWhat/how/when to submi
 t an MDR\nContents of the reporting form\nUtilizing MDR information as qu
 alitative data\n\nSubmission of Vigilance Reports to EU Competent Authori
 ties:\n\nWhat/how/when to submit a Vigilance Report\nContents of the repo
 rting form\n\nWhat to do when a medical device needs to be recalled:\n\nW
 hat/how/when to initiate a medical device product recall\nContents of the
  recall reports and records\nRecall execution and closure\n\nTo discussio
 n of key case studies and how to prevent compliance issues related to Com
 plaint Management\, MDR\, Vigilance reporting and medical device product 
 recalls\nTo review the key concepts and implementation steps for an effec
 tive Post Market Surveillance system\n\nWho will Benefit:\nAnyone that pa
 rticipates in product complaint management\, medical device reporting\, v
 gilance reporting\, and/or product recalls:\n\n\nRegulatory Affairs Perso
 nnel\nQuality managers and those working in sales or marketing\nLegal Per
 sonnel\nCompliance Professionals\nClinical affairs specialists and those 
 handling complaints\nMedical Affair Professionals\nDesign Control Manager
 s\nRisk Managers\n
DTEND:20250526T043000
DTSTAMP:20260512T232951Z
DTSTART:20250526T090000
LOCATION:\,
SEQUENCE:0
SUMMARY:This two day interactive seminar will focus on:\n\nComplaint Manag
 ement\nMedical Device Reporting (MDR)\nEU Vigilance Reporting\nProduct Re
 calls...
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