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DTSTART:19700308T020000
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UID:2140535:Event:468647
DTSTAMP:20260521T181703Z
SUMMARY:Medical Device Single Audit Program
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.\nWhy Should You Attend:\nThis 6
  hrs. webinar is focused on understanding the Medical Device Single Au
 dit Program, the scope of the program, how to apply, the Authorized Or
 ganizations, the rating system developed and what you can expect when 
 signing onto the program. The webinar will discuss how such audits are
  organized, what to expect during a MDSAP audit, how does this differ 
 from a typical certified body audit, along with document movement and 
 timeline expectations in receiving the facility’s certificate.\nHigh
 lights of the key Regulatory Requirements for Medical Devices will als
 o be covered for the participating MDSAP Countries of: U.S., Canada, B
 razil, Australia and Japan.\nLearning Objectives:\n\nThe Medical Devic
 e Single Audit Program (MDSAP)\nDevice Classification\nLicensing Pathw
 ays\nMedical Device GMP\nInspections\nDevice Labeling\nLicense Holder 
 Responsibilities\nTimelines and Fees\nCountry Specific Cultural Consid
 erations and Challenges\nAdverse Event Reporting\n\n\nWho Will Benefit
 :\n\nRegulatory Affairs\nQuality assurance, quality control, and quali
 ty systems\nProduct development personnel\nContract research organizat
 ions\nBusiness management\nSite managers\nSenior and executive managem
 ent\nContractors and subcontractors\nDistributors\nConsultants\n\n\n\n
 \n\n\nFor more information visit https://medtechiq.ning.com/events/med
 ical-device-single-audit-program
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/8935069684?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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