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

Jim Jones, Chair, FMMC Symposium Committee

 

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.

1:10 - 1:30

Hot Topics: Key FDA Priorities & Initiatives

Topics: Program Alignment, FDARA, Transparency, Nonbinding Form 483 Feedback, 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
1:30 - 3:00

Med Device Compliance and Enforcement

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

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

Joshua Silvestri, CSO,

Investigator/Device Specialist

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

Global Trends in the Medical Device Industry and Supply Chain

Anthony S. Freeman
President

A.S. Freeman Advisors, LLC

5:30 - 7:30

Opening Night Reception & Exhibit Hall Grand Opening

 Join us for cocktails, hors d’oeuvres, networking, and exhibits.

Picasso DEF
TUES|MAY 14    
7:15 - 8:45 Full Breakfast Buffet with Exhibitors Picasso DEF
8:45 - 9:25

Powering Peak Performance: Using Operational Data Effectively to Grow Your Business

Manufacturers routinely collect data to understand their operational processes and eliminate pain points in their workflows. From employee performance metrics to downtimes to demand forecasting, this operations data is only useful to those who know how to collect and interpret it effectively. Unfortunately, companies struggle with data collection and analysis. To overcome this pervasive challenge, it’s critical to engage every employee in soliciting insights and information about the state of business operations in your organization. Once employees buy into and rally around a common vision for improving operations, you can design “smart data” collection strategies to target just the data you need to drive results. A number of techniques and tools are available to help you maximize the effectiveness of working with the data you’ve collected. And a number of real-life examples can provide insights and inspiration as you jump-start your company’s journey to operational peak performance.

Tim Dorsey, President & CEO

The Dorsey Group

 

Carla Dorsey, VP & COO

The Dorsey Group

9:25 - 10:15

What’s New with 510(k)s?

Section 510(k) of the Food, Drug and Cosmetic Act requires device makers to notify FDA of their intent to market a medical device that is at least as safe and effective – substantially equivalent – to a legally marketed device. Most medical devices in the U.S. today are marketed under the 510(k) pathway which has been around since 1976. The 510(k) program is the subject of literally hundreds of FDA guidance documents, including several over the past year which propose to significantly “modernize” this device approval pathway. But what’s really “new” with the 510(k) program? Attend this session to get the latest and greatest on the essential 510(k) pathway.

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

 

Valerie Followell

President

Followell Compliance Consultants

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

Industry 5.0: How Robotics, Advanced Automation, and Machine Learning Are Changing the Face of MedTech Manufacturing

The skilled labor market is the most competitive in history, operational costs are skyrocketing, and marketplace demands for speed of response and customization are ever increasing. Offshoring and the low cost labor model has run its course, and the Global Manufacturing Competitiveness Index has the US predicted to be number one in 2020 over China. Are you ready? This panel will discuss Industry 5.0, the connectedness between humans and machines, and how to leverage automation to become more productive and profitable. And we will also hear from an educational leader on how state colleges are preparing the students of tomorrow for this coming wave of change. 

Sean Dotson

President & CEO, RND Automation


Lara Sharp

Program Director, St. Pete College – Engineering, Manufacturing, and Building Arts

Doug Adams

Vice President, Adams Automation & Controls, Inc.

11:40 - 12:30

Software Validation: Practical Approaches to Achieve Compliance While Saving Time and Resources

Medical device firms are required to validate “electronic systems” that create, modify, maintain, archive, retrieve, or transmit electronic records. But the challenge is while FDA regulations and international  standards require software validation, they do not specify how companies should go about the validation process. This session will explore the common validation problems encountered by regulated companies. And our speaker will cover what you need to know to validate your medical device software to meet FDA’s expectations and how to prove to FDA that you validated your software properly and successfully.

Erin Wright

Validation Product Manager MasterControl

12:30 - 1:45

Keynote Luncheon

Florida’s Economy: Healthy or Ailing?

Dr. 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

 

Biocompatibility Compliance: How to Address New Regulatory Changes that Impact Medical Devices
This special session will examine the shifting regulatory landscape for medical device biocompatibility that is evolving with the new release of the EU's Medical Device Regulation (MDR) and the recent updates to the ISO 10993 suite of standards including 10993-1, 10993-18 and those to follow. After May 2022, all devices sold in the European market will have to demonstrate compliance with ISO 10993, even if the device has been on the market for years. These recent regulatory changes and those in the pipeline need to be evaluated within the context of an existing biocompatibility program. In this workshop, you will learn how to evaluate your biocompatibility information and determine what the gaps are and your options in addressing them. This presentation will also walk through a real-life example of bringing a device that has been on the market in Europe into compliance with the ISO 10993 and the new MDR.
Nicholas J. Christiano, M.S., M.B.A.
Senior Manager - E&L Medical Devices
Nelson Laboratories, LLC

5:00 - 5:05 Closing Remarks & Adjourn Geary Havran, Chairman, FMMC
     

**Times and topics subject to change

 

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