DUBLIN, Aug. 3, 2021 /PRNewswire/ -- The "Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan" training has been added to ResearchAndMarkets.com's offering.
This 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 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.
Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies.
Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways 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 would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia and Japan. Health Canada has now made the MDSAP process mandatory for all licensed products in Canada.
Why Should You Attend:
Highlights of the key Regulatory Requirements for Medical Devices will also be covered for the participating MDSAP Countries of: U.S., Canada, Brazil, Australia and Japan.
The Medical Device Single Audit Program (MDSAP)
Medical Device GMP
License Holder Responsibilities
Timelines and Fees
Country-Specific Cultural Considerations and Challenges
Adverse Event Reporting
Key Topics Covered:
Introduction and Agenda Review
Medical Device Single Audit Program (MDSAP): Overview, History, Audit Process and Report
U.S. FDA - Overview of Medical Device Regulations and Regulatory Processes throughout the Product Life Cycle
Canada - Overview of Health Canada Medical Device Regulations and Regulatory Processes throughout the Product Life Cycle
Brazil - Overview of ANVISA Medical Device Regulations and Regulatory Processes throughout the Product Life Cycle
Australia - Overview of TGA Medical Device Regulations and Regulatory Processes throughout the Product Life Cycle
Japan - Overview of PMDA Medical Device Regulations and Regulatory Processes throughout the Product Life Cycle
Working Effectively with In-Country Regulatory Agencies
For more information about this training visit https://www.researchandmarkets.com/r/dfdfpf
Research and Markets
Laura Wood, Senior Manager
For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1904
Fax (outside U.S.): +353-1-481-1716
View original content:https://www.prnewswire.com/news-releases/6-hour-virtual-seminar-on-medical-device-single-audit-program-mdsap-implementation--participating-country-regulatory-processes-us-canada-brazil-australia-and-japan-august-11-2021-301346856.html
SOURCE Research and Markets