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2020 Symposium Agenda
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THUR|OCT 1    
10:00 - 1:00 Registration/Exhibitor Set-up  
1:00 - 1:10 Welcome & Opening Remarks

Jim Jones, Chair, FMMC Symposium Committee


Geary Havran, Chairman, FMMC

FDA "Super Session"

Hear from and network with key FDA officials and staff who lead all medical device inspectional and compliance activities covering eighteen (18) states from Florida to Minnesota. This interactive FDA session will cover a myriad of compliance and regulatory issues critical to the medtech industry, as well as Q&A and discussion.

1:10 - 1:30

Key FDA Priorities & Initiatives

Blake Bevill, Division Director, Office of Medical Device and Radiological Health Operations (OMDRHO/Division 2), U.S. Food & Drug Administration

1:30 - 3:00

Hot Topics and Trends in Medical Device Audits and Compliance

  • Device Inspectional Issues
  • Top 483 Observations and Recent Trends
  • cGMP/QSIT Compliance Issues
  • Unique Device Identification (UDI)
  • Warning Letters

Kathleen M. Sinninger, Director, Investigations Branch, ORA/ Office of Medical Device & Radiological Health Div 2

Joshua Silvestri, CSO,
Investigator/Device Specialist
U.S. FDA (Maitland, FL)

Salvatore N. Randazzo
Compliance Officer
Office of Medical Devices and Radiological Health Operations (OMDRHO) Division 2 – Central 

3:30 - 4:15 Capital Review: Comprehensive Update on Issues Facing the Medical Device Industry in Washington
Brendan Benner
Executive VP of Public Affairs
Medical Device Manufacturers Association (MDMA)

4:15 - 5:15

Keynote Presentation:

"Becoming the #1 Choice in a Crowded Market"

Gerry O’Brion
What Big Brands Know

5:30 - 7:30

Opening Night Reception & Exhibit Hall Grand Opening -Join us for cocktails, hors d’oeuvres, networking, and exhibits.

Picasso DEF
FRI|OCT 2    
7:00 - 8:30 Full Breakfast Buffet with Exhibitors Picasso DEF
8:30 - 9:20

Mastering the Critical Success Factors in the Bringing a New Device to Market

Panel Session

9:20 - 10:15

Navigating European Union MDR Implementation in the Wake of Brexit

John Bis, Vice President

Regulatory Sevices (Medical Devices), Americas

BSI Group

Alex Butler, Manager

Medical Device Solutions


10:15 - 10:45 Refreshment Break with Exhibitors Picaso DEF
10:45 - 11:40

Emerging Challenges in the Sterilization of Medical Devices: What’s Your Plan B?

Aaron DeMent
VP of Global Quality Assurance


Mac McKeen

Felllow, Regulatory Science

Boston Scientific

11:40 - 12:30

Best Practices in Risk Mitigation, Disaster Preparedness and Business Continuity Planning

Panel Session

12:30 - 1:45

Keynote Luncheon

Keynote Luncheon Presentation

Speaker TBA

2:00 - 2:05 Closing Remarks & Adjourn Geary Havran, Chairman, FMMC

**Times and topics subject to change


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