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:63336 DTSTAMP:20260521T113847Z SUMMARY:Best Practices for Implementing an Adverse Event Reporting Sys tem for Medical Devices Including IVDs DESCRIPTION:This training on Medical Device Reporting (MDR) requiremen ts will provide attendees the best practices for implementing an adver se event reporting system for medical devices including in vitro diagn ostic devices (IVDs).\n\nWhy Should You Attend:\nIn the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medic al Device Reporting (MDR) regulations have required firms who have rec eived complaints of device malfunctions, serious injuries or deaths as sociated with medical devices to notify FDA of these incidents. MDR is the mechanism for the FDA to receive reports of significant medical d evice adverse events from manufacturers, importers and user facilities , so they can be detected and corrected quickly. To achieve compliance and to remain compliant, it is critical to accurately interpret and u nderstand the applicable medical device reporting regulations to adequ ately implement an adverse event reporting system for medical devices including IVDs.\nThis 60-min webinar will provide a great opportunity to help establish and maintain adequate procedures for medical device reporting in a way that one would differently plan, develop and execut e the relevant procedures in an efficient and effective manner.\nDurin g this webinar, the speaker will share his practical, actionable and s ustainable perspectives to help attendees increase awareness and famil iarity of the regulatory requirements.\nAreas Covered in the Webinar:\ n\nApplicable statutes and regulations\nDefinitions\nRegulatory requir ements for Medical Device Reporting\nHow to report an adverse event\nR eporting requirements for the user facilities, manufacturers, and impo rters\nRequired elements to be contained in your standard operating pr ocedures\nHow to implement an adverse event reporting system\nEnforcem ents: Case Studies\nGood Practices\nConclusion\n\nWho will Benefit:\n\ nCEOs\nVPs\nRegulatory affairs (associates, specialists, managers, dir ectors or VPs)\nQuality professionals (associates, specialists, manage rs, directors or VPs)\nR&D (engineers, scientists, managers, directors or VPs)\nComplaint and risk management personnel\nConsultants\nContra ctors/subcontractors\nClinical affairs (associates, specialists, manag ers, directors or VPs)\nOther interested parties\n\nInstructor Profile :\nDr. David Lim, Ph.D., RAC, ASQ-CQA is President and Principal of R egulatory Doctor (www.RegulatoryDoctor.com). Dr. Lim frequently presen ts global regulatory and quality compliance topics in various forums a nd meetings. Recently, he developed 510(k) templates ready for use com pliant with e-Copy and RTA policy. In addition, he developed FDA inspe ction checklists for drug and medical device manufacturers based on hi s analysis of FDA inspectional observations cited in 483s for the past seven years. He provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.\n\nFor more informati on visit https://medtechiq.ning.com/events/best-practices-for-implemen ting-an-adverse-event-reporting-system DTSTART;TZID=America/New_York:20140305T100000 DTEND;TZID=America/New_York:20140305T110000 CATEGORIES:medical LOCATION:Online Event WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu s/~product_id=703248?channe=medtechiq URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p roduct_id=703248?channe=medtechiq CONTACT:+1-650-620-3915 ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer ral512 ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562006613?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc eOnline:https://medtechiq.ning.com/profile/Referral512 END:VEVENT END:VCALENDAR