Overview
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 the 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 the safety of 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 you should attend
This 4 hours seminar 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 Seminar will discuss how such audits are organized, what to expect during an MDSAP audit, and how this differs 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 the U.S., Canada, Brazil, Australia, and Japan.
Learning Objectives:
- The Medical Device Single Audit Program (MDSAP)
- Device Classification
- Licensing Pathways
- Medical Device GMP
- Inspections
- Device Labeling
- License Holder Responsibilities
- Timelines and Fees
- Country-Specific Cultural Considerations and Challenges
- Adverse Event Reporting
Who Will Benefit
- Regulatory Affairs
- Quality Assurance, Quality control, and Quality systems
- Product Development Personnel
- Contract Research Organizations
- Business Management
- Site Managers
- Senior and Executive Management
- Contractors and Subcontractors
- Distributors
- Consultants
Agenda
- 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
- Q&A Session
Speaker Profile
Robert J. Russell is a Global Regulatory and CMC expert with 28 years of prior industry experience in international regulatory management and compliance, global business development and global supply chain management. Mr. Russell formerly held senior leadership positions, in these functional areas, at Dow Pharmaceuticals and Cordis-Dow Medical Devices.
His experience and knowledge span Healthcare Authority’s requirements and regulatory processes across Life Science products.
For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries.
He holds a BS / MS in Chemistry."
