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DTSTART:19700308T020000
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DTSTAMP:20260416T124500Z
SUMMARY:Medical Device Single Audit Program [MDSAP] Implementation
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.\n\nLearning Objectives:\n\nThe Medical Dev
 ice Single Audit Program (MDSAP)\nDevice Classification\nLicensing Pat
 hways\nMedical Device GMP\nInspections\nDevice Labeling\nLicense Holde
 r Responsibilities\nTimelines and Fees\nCountry Specific Cultural Cons
 iderations and Challenges\n\nWho Will Benefit:\nThis 6 Hrs. webinar wi
 ll provide invaluable assistance to all personnel in the Medical Devic
 e industry, who have a stake in expanding their business into a MDSAP 
 participating country and for those interested in more information abo
 ut MDSAP and how it may apply to them.\nThis webinar will be particula
 rly useful for those involved in research and development, document cr
 eation for regulatory submission, data handling and for those conducti
 ng/monitoring/coordinating clinical investigation, performing risk man
 agement and post-market vigilance/surveillance. This seminar is a must
  for those who are looking to apply for a medical device registration 
 and product license in a MDSAP country.\nThose employees working in th
 e following roles will significantly benefit by attending:\n\nRegulato
 ry Affairs\nQuality assurance, quality control, and quality systems\nP
 roduct development personnel\nContract research organizations\nBusines
 s management\nSite managers\n\n\nFor more information visit https://me
 dtechiq.ning.com/events/medical-device-single-audit-program-mdsap-impl
 ementation
DTSTART;TZID=America/New_York:20211202T110000
DTEND;TZID=America/New_York:20211202T170000
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/9750475289?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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