This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.
Why You Should Attend
This 90-minute webinar is focused on understanding the Medical Device Single Audit Program (MDSAP), 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.
- Introduction and Agenda Review
- Medical Device Single Audit Program (MDSAP): Overview, History, Audit Process and Report
- U.S. FDA – Overview of Medical Device Regulations
- Device Classification, Licensing Pathways, Human Factors and Usability Studies, Medical Device GMP, Inspection Process, Device Labeling, Combination Products, License Holder Responsibilities
- Canada – Overview of Health Canada Medical Device Regulations
- Brazil -- Overview of ANVISA Medical Device Regulations
- Australia – Overview of TGA Medical Device Regulations
- Japan – Overview of PMDA Medical Device Regulations
- Working with Country Regulators
- Q&A Session
Who Will Benefit
- Regulatory Affairs Personnel
- Quality Assurance, Quality Control, and Quality Systems Professionals
- Product Development Personnel
- Senior and Executive Management
- Contractors and Subcontractors
For the past 9 years, Robert J. Russell has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device, and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has an MS degree in Chemistry.