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2020 Virtual Symposium Agenda
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THUR|OCT 1  AGENDA UNDER DEVELOPMENT  
  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.

 

Key FDA Priorities & Initiatives


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

 

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 

  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)

 

Keynote Presentation:

"Becoming the #1 Choice in a Crowded Market"

Gerry O’Brion
What Big Brands Know

 

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

MasterControl

 

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

Aaron DeMent
VP of Global Quality Assurance
Sterigenics

 

Mac McKeen

Felllow, Regulatory Science

Boston Scientific

  Closing Remarks & Adjourn Geary Havran, Chairman, FMMC
     

**Times and topics subject to change

 

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