The "Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan" conference has been added to ResearchAndMarkets.com's offering.
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:
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.
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
Who Should Attend:
This 6 Hrs. webinar will provide invaluable assistance to all personnel in the Medical Device industry, who have a stake in expanding their business into a MDSAP participating country and for those interested in more information about MDSAP and how it may apply to them.
This webinar will be particularly useful for those involved in research and development, document creation for regulatory submission, data handling and for those conducting/monitoring/coordinating clinical investigation, performing risk management 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.
Those employees working in the following roles will significantly benefit by attending:
Quality assurance, quality control, and quality systems
Product development personnel
Contract research organizations
Senior and executive management
Contractors and subcontractors
May 26, 2021 (11:00 AM to 5:00 PM EDT)
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
Device Classification, Licensing Pathways, Human Factors and Usability Studies, Medical Device GMP, Inspection Process, Device Labeling, Combination Products, License Holder Responsibilities
(NOTE: Each country session will follow a similar format to the information above)
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 conference visit https://www.researchandmarkets.com/r/eaop6t
View source version on businesswire.com: https://www.businesswire.com/news/home/20210512005815/en/
Laura Wood, Senior Press Manager
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