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MON|MAY 13    
10:00 - 1:00 Registration/Exhibitor Set-up  
1:00 - 1:05 Welcome & Opening Remarks

Jim Jones, Chair, FMMC Symposium Committee

1:05 - 1:20 The State of Florida’s MedTech Economy John Ray, Executive Director, 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.

1:20 - 1:40

Updates on Key FDA Priorities & Initiatives

Topics include Program Alignment, FDARA, Transparency, Nonbinding Form 483 Feedback, MDSAP, Experiential Learning and Regulatory Convergence/ISO

Blake Bevill, Division Director, Office of Medical Device and Radiological Health Operations (OMDRHO/Division 2), U.S. Food & Drug Administration
1:40 - 3:00

FDA-Industry Panel: Hot Topics

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

Melissa Michurski
Director of Compliance (OMDRHO/Division 2, Minneapolis, MN), FDA

Joshua Silvestri, CSO, U.S. Food & Drug Administration
(Maitland, FL)

Neisa Alonso, Recall Coordinator, FDA

(Maitland, FL)

Jeffrey Shapiro, Director Hyman, Phelps & McNamara, P.C.

3:00 - 3:30 Refreshment Break with Exhibitors  
3:30 - 4:15 Washington Review: Comprehensive Update on Issues Facing the Medical Device Industry in the 116th Congress
Mark Leahey, President & CEO, Medical Device Manufacturers Association (MDMA)

4:15 - 5:15

Keynote Session TBA
5:30 - 8:30

Opening Night Reception & Exhibit Hall Grand Opening

Join us for cocktails, hors d’oeuvres, networking, exhibits and an evening capped off with live music under the beautiful Florida weather.

Picasso DEF/Patio
TUES|MAY 14    
7:30 - 8:30 Full Breakfast Buffet with Exhibitors Picasso DEF
8:30 - 9:30 What’s New with 510(k)s?

Lisa Michels J.D., M.S.O.L.Q
General Counsel & Regulatory Affairs Expert, Regulatory Compliance Associates (RCA)

9:30 - 10:30 Best Practices in Software Validation for Medical Device Manufacturers

Panel Session

10:30 - 11:00 Refreshment Break with Exhibitors  
11:00 - 12:00 Best Industry 4.0/5.0: How Robotics, Advanced Automation, and Machine Learning Are Changing the Face of MedTech Manufacturing

Panel Session

12:00 - 1:30

Keynote Luncheon

Florida’s Economy: Healthy or Ailing?

Christopher McCarty

Director,  Bureau of Economic and Business Research (BEBR) and Associate Dean, College of Liberal Arts and Sciences,

University of Florida

2:00 - 5:00

Special Workshop

 

**Additional Registration Required ($99)

 

**Symposium + Workshop Package Discounts Available

 

New Regulatory Changes that Impact Medical Devices: Using Chemistry to Assess Safety
This special session will examine the shifting regulatory landscape that is evolving with the new release of ISO 10993-1, the MDRs, and draft ISO 10993-18. An overview of the strategic options available for the evaluation of medical device biocompatibility will be provided, including the use of chemistry and biological risk assessments to save time, money, and spare animal life.
Presented by Nelson Labs
5:00 - 5:05 Closing Remarks & Adjourn Geary Havran, Chairman, FMMC
     

**Times and topics subject to change

 

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