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:468413 DTSTAMP:20260521T051657Z SUMMARY:Medical Device Single Audit Program [MDSAP] Implementation &am p; Participating Country Regulatory Processes DESCRIPTION:Global Medical Device Regulations continue to evolve, as d evices become more diverse and sophisticated. Understanding the regula tions and requirements in your targeted markets will expedite speed-to -market of innovative products and assist patients needing access to l ife-saving products and technologies. Government Regulatory Authoritie s, needing to become more efficient with their time, are looking for w ays to better use their internal resources without compromising safety in products, which become marketable. One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations w ould be allowed to carry out a single GMP audit on medical device manu facturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Aust ralia and Japan. Health Canada has now made the MDSAP process mandator y for all licensed products in Canada.\n\nWhy Should You Attend:\nThis 6 hrs. webinar is focused on understanding the Medical Device Single Audit Program, the scope of the program, how to apply, the Authorized Organizations, the rating system developed and what you can expect whe n signing onto the program. The webinar will discuss how such audits a re organized, what to expect during a MDSAP audit, how does this diffe r from a typical certified body audit, along with document movement an d timeline expectations in receiving the facility’s certificate.\nHi ghlights of the key Regulatory Requirements for Medical Devices will a lso be covered for the participating MDSAP Countries of: U.S., Canada, Brazil, Australia and Japan.\n\nLearning Objectives:\n\nThe Medical D evice Single Audit Program (MDSAP)\nDevice Classification\nLicensing P athways\nMedical Device GMP\nInspections\nDevice Labeling\nLicense Hol der Responsibilities\nTimelines and Fees\nCountry Specific Cultural Co nsiderations and Challenges\nAdverse Event Reporting\n\nWho Will Benef it:\nThis 6 Hrs. webinar will provide invaluable assistance to all per sonnel in the Medical Device industry, who have a stake in expanding t heir business into a MDSAP participating country and for those interes ted in more information about MDSAP and how it may apply to them.\nThi s webinar will be particularly useful for those involved in research a nd development, document creation for regulatory submission, data hand ling and for those conducting/monitoring/coordinating clinical investi gation, performing risk management and post-market vigilance/surveilla nce. This seminar is a must for those who are looking to apply for a m edical device registration and product license in a MDSAP country.\n\n Regulatory Affairs\nQuality assurance, quality control, and quality sy stems\nProduct development personnel\nContract research organizations\ nBusiness management\nSite managers\nSenior and executive management\n Contractors and subcontractors\nDistributors\nConsultants\n\n\nFor mor e information visit https://medtechiq.ning.com/events/medical-device-s ingle-audit-program-mdsap-implementation-amp-1 DTSTART;TZID=America/New_York:20210526T110000 DTEND;TZID=America/New_York:20210526T170000 CATEGORIES:seminae LOCATION:online WEBSITE:https://www.complianceonline.com/medical-device-single-audit-p rogram-mdsap-implementation-regulatory-processes-us-canada-brazil-aust ralia-japan-seminar-training-80493SEM-prdsm?channel=MedTech%20I.Q URL:https://www.complianceonline.com/medical-device-single-audit-progr am-mdsap-implementation-regulatory-processes-us-canada-brazil-australi a-japan-seminar-training-80493SEM-prdsm?channel=MedTech%20I.Q CONTACT:8887172436 ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer ral512 ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0 /file/get/8722271095?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc eOnline:https://medtechiq.ning.com/profile/Referral512 END:VEVENT END:VCALENDAR