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 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 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.
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)
- Device Classification
- Licensing Pathways
- Medical Device GMP
- 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
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.
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
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08:00 AM PST | 11:00 AM EST
- 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
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
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