2017 Medical Device Regulations Conference & Workshop
November 7-8, 2017
Schedule of Events
Tuesday, November 7, 2017:
Implementing the Medical Device Single Audit Program (MDSAP) with ISO 13485: 2016 Considerations
7:30 – 8:00 AM: Workshop Registration
8:00 – 5:30 PM: Workshop
The Medical Device Single Audit Program (MDSAP) is an international initiative led by five Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements.
Five of the RAs (Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW) conducted a three-year pilot program that ended in December 2016 and the formal program began in January 2017. Health Canada announced that as of 1 January 2019, it will terminate the current CMDCAS program and only accept MDSAP certificates. If MDSAP certificates are not provided to Health Canada by January 1, 2019, for existing Canadian Licenses of class II, III, and IV medical devices, the associated devices will no longer be permitted to be marketed/sold in Canada.
Is your QMS ready for the MDSAP Program? What about ISO 13485:2016?
Join us for a one-day workshop where Angie Combs (BSI’s MDSAP Expert) and industry experts will provide training to help prepare your organization for a MDSAP compliant QMS while also providing comparisons to ISO 13485:2016. Industry experts who have already undergone MDSAP audits will also provide implementation strategies and watch-outs that they have learned.
At the completion of this workshop, you should have a general working knowledge of:
- What is the MDSAP Program?
- How MDSAP works?
- How does MDSAP fit with other certifications?
- MDSAP financial impacts
- MDSAP audit duration impacts
- MDSAP grading scale
- Understanding the requirements of the MDSAP Audit Model
- Using the MDSAP Companion Document as your guide to compliance
- Comparisons to ISO 13485:2016
- Implementation strategies/watch-outs
Tuesday, November 7, 2017: Networking Reception 6:30 PM – 8:30 PM:
Networking Reception (Location: TBD)
Main Conference: Wednesday, November 8, 2017
|7:00-8:00 AM||Registration Breakfast and Networking||UGA Gwinnett|
|8:00-8:15 AM||Welcome/Conference Overview Introduction of Speakers||David Mullis, Ph.D., RAC, FRAPS University of Georgia Ingrid A. Zambrana Food and Drug Administration|
|8:15-9:15 AM||What to expect with FDA’s ORA Alignment||Anne P. Reid, MS Deputy Director, Medical Device/RH Program, Office of Regulatory Affairs, Food and Drug Administration|
|9:15-10:15 AM||Defending Device Claims–FDA & FTC||Alan Minsk, JD
Partner, Arnall Golden Gregory Attorneys at Law
|10:30-11:30 AM||Preparing for the new EU Medical Device Regulations (EU MDR)||Ibim Tariah, PhD Technical Director, BSI Healthcare|
|11:30 AM-12:15 PM||MEDDEV 2.7.1 Revision 4 Changes – Clinical Evaluation Report (CER) Requirements & Impacts to Regulatory and Operational Strategies||Mary Beth Henderson, PhD VP, RA/QS Senior Principal Advisor, RCRI|
|12:15-1:15 PM||Lunch and Networking|
|1:15-2:15 PM||Best practices for compliance with ISO 13484:2016||Russ Rainey Quality Systems Integration Leader, Halyard Health|
|2:15-3:15 PM||Expectations of Contract Manufacturer Controls from an FDA Perspective||David Van Houton Compliance Officer, Tennessee Office of Medical Device and Radiological Health Operations Food and Drug Administration|
|3:30-4:30 PM||Importance of Quality and Regulatory throughout the Merger and Acquisition Life Cycle-Landmines and Opportunities||Wilfredo Ruiz-Cabán Executive Vice President Quality Assurance, Regulatory Affairs & Operations, Conmed|
|4:30-5:00 PM||Panel Discussion Q & A|