Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Why Should You 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.

Topics to be Discussed:

• 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

Areas Covered in the Webinar:

• 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
• (NOTE: Each country session will follow a similar format to the information above)
• 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:

This 90-minute 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 webinar is a must for those who are looking to apply for a medical device registration and product license in a MDSAP country. Employees who will significantly benefit by attending this training include:

• Regulatory Affairs Personnel
• Quality Assurance, Quality Control, and Quality Systems Professionals
• Product Development Personnel
• Contract Research Organizations Personnel
• Business Management
• Site Managers
• Senior and Executive Management
• Contractors and Subcontractors
• Distributors
• Consultants

Robert J Russell
President and CEO, RJR Consulting, Inc

Bob 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.

Topic Background:

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, requiring 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.

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