MedCon Conference Sessions Agenda: Day 1

WEDNESDAY, MAY 1, 2019

 

7:45 AM - 8:30 AM

Breakfast

Join your colleagues from around the globe as we kick off MedCon with a complimentary warm breakfast.


8:30 AM  -  9:00 AM

Let's Make a Difference!

Welcome to the Conference, welcome to Xavier University, and welcome to the Cincinnati District of the FDA. This purpose-driven conference will lead you to actionable learning and implementation plans.

Moderator:

  • Marla Phillips (Co-Chair), Director, Xavier Health, Xavier University

Speakers:

  • Gina Brackett, Director Compliance Branch, FDA-ORA (invited)

  • Joe Matrisciano, Divisional Director, Office of Medical Device and Radiological Health Operations, Division 1, FDA-ORA (invited)

  • Marla Phillips, Director, Xavier Health, Xavier University


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9:00 AM - 9:45 AM

The Solution Xchange

Start your day with solutions! This fast-paced, engaging session draws out your experience and ideas by having you work collaboratively with your colleagues to address the challenges that will be discussed throughout the conference, while tying your ideas to the hopes of a patient whose life is depending on you.

Moderator:

  • Dennis Hahn, Director, Regulatory Policy Innovation, Johnson & Johnson Medical Devices

Speaker:

  • Dennis Hahn, Director, Regulatory Policy Innovation, Johnson & Johnson Medical Devices


9:45 AM - 10:05 AM

Break


10:05 AM - 10:50 AM

Center Director Corner: Strategic Priorities for 2018 and Beyond

Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH) will provide insight on progress and direction of the 2018-2020 strategic priorities related to protecting public health, including collaborative activities shared with industry on the balance of safety, efficacy, quality, access, and innovation.

Moderator:

  • Kim Trautman, Executive Vice President, Medical Device International Services, NSF International

Speaker:

  • Jeff Shuren, Director of the Center for Devices and Radiological Health, FDA-CDRH (remote)


10:50 AM - 11:35 AM

FDA Office of Medical Device and Radiological Health Operations Update and Strategic Priorities

The Office of Medical Device and Radiological Health Operations (OMDRHO) houses all medical device and radiological health investigators across the country. Understand the key OMDRHO initiatives that are on the horizon, and the expectations FDA has of your organization to protect and promote patient health.

Moderator:

  • Gina Brackett, Director Compliance Branch, FDA-ORA (invited)

Speakers:

  • Jan Welch, Director, Office of Medical Device and Radiological Health Operations, FDA-ORA (invited)


11:35 AM - 12:50 PM

Lunch Networking by Topic

Sit with FDA officials, speakers, industry experts and your colleagues at tables dedicated to topics that are important to you. Enjoy the discussion with others who share your passion.


12:50 PM - 2:15 PM

TRACk 1 (International)

Beyond MDSAP and ISO 13485: Multi-Purpose Global Regulatory Audits

Expert leaders will engage participants in practical discussions for how best to prepare for successful Multi-Purpose Regulatory Audits. Expert leaders will share invaluable benchmark information you won't want to miss on best practices for preparation and execution of Regulatory Audits that are MDSAP and EU combined. You will be engaged in exploring the challenges of multi-jurisdictional Regulatory Audits and will understand real experiences to date.

Moderator:

  • Kim Trautman, Executive Vice President, Medical Device International Services, NSF International

Speakers

  • David Pieratos, Director, Regulatory Affairs, BD

  • Kimberly Soter, VP Quality, Olympus Surgical

  • Kim Trautman, Executive Vice President, Medical Device International Services, NSF International

TRACk 2 (PostMarket Track)

Follow the Defect: Case of the Missing Cavity

FDA will explore a case study with you on how to manage a production defect in a critical life saving device that is in product shortage. The case study includes how the production defect was identified, the risk-based decisions that were made, and the concerns related to the solution. Participants will delve into the impact of decisions on pre-market design, production, corrective actions and how to maintain product availability while assuring consumer safety.

Moderator:

  • Gina Brackett, Director Compliance Branch, FDA-ORA (invited)

Speakers:

  • Ben Dastoli, Investigator, Medical Device Specialist, FDA-ORA (invited)

  • David Elder, Executive Vice President, Regulatory Compliance, Greenleaf Health

  • Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding

  • Phil Pontikos, National Device Expert, FDA-ORA (invited)

  • Adam Saltman, Medical Officer, Office of Compliance, FDA-CDRH (invited)

TRACk 3 (PreMarket Track)

Improve Your Pre-Market Review, Know What's New!

What’s new in CDRH premarket processes, what’s new for preparing your submissions, and what’s new for interacting with FDA? Experts will share tips for success on how best to navigate the tools and processes available for your product approval. Build a strategy that's right for your product by understanding the nuts and bolts of pre-market submissions.

Moderator:

  • Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products (Vice President Regulatory Affairs, MDMA), Greenleaf Health

Speakers:

  • Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS

  • Marjorie Shulman, Chief of Premarket Notification (510(k)) Section, FDA-CDRH (invited)


2:15 PM - 2:35 PM

Break


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2:35 PM - 3:35 PM

TRACk 1 (International)

Beyond MDSAP and ISO 13485: The Impact of the New EU Regulations on Audits

Discuss with your colleagues how to manage the necessity of integrating your regulatory affairs and quality assurance functions, including the technical documentation and objective evidence necessary for successful audit outcomes. You will walk away with some strategies for the competencies needed to manage the audit and objective evidence needed for today's regulatory audit expectations and your company's success

Moderator

  • Kim Trautman, Executive Vice President, Medical Device International Services, NSF International

Speakers

  • Rania Gerges, Quality Assurance Consultant , Qserve Group

  • Laila Gurney, Head of Global Regulatory Affairs, GE Healthcare

  • Kim Trautman, Executive Vice President, Medical Device International Services, NSF International

 TRACk 2 (PostMarket Track)

FDA Mock Inspection: Knock Knock! Guess Who’s at Your Door?

Participate in a rare opportunity to engage in an interactive FDA mock inspection with FDA investigators! By exploring challenging scenarios, you will understand how to prepare your organization for success. Participants will be exposed to 21st Century Inspectional Techniques and how to manage them during the stress of an ongoing FDA inspection. FDA investigators focus on different areas based upon their individual expertise. Learn how to navigate and respond to questions that may seem daunting, while demonstrating a culture of quality at your firm – and avoid FDA leaving with the wrong impression.

Moderator:

  • Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding

Speakers:

  • CAPT Sean M. Boyd, Deputy Director for Regulatory Affairs, Office of Compliance, FDA-CDRH (invited)

  • Gina Brackett, Director Compliance Branch, FDA-ORA (invited)

  • Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding

  • Monica Wilkins, Divisional Vice President of Medical, Clinical, Quality and Strategic Support, Abbott



TRACk 3 (PreMarket Track)

Getting Your Product on the Market: Premarket Approval is Only the Beginning

We often are only focused on FDA and global regulator approval of our products. However, this is only the beginning, since having a product on the market that will not be reimbursed is as good as not having your product on the market at all! In this session, you will gain a deeper understanding of what is critical to the reimbursement process, what insurance agencies require, and why it is paramount to integrate cross-functional priorities across the total product lifecycle for the ultimate success of your product. Your patients and consumers are counting on you to master this process for the accessability of the products they need.

Moderator:

  • Adam Saltman, Medical Officer, Office of Compliance, FDA-CDRH (invited)

Speakers:

  • FDA and Industry TBA


3:35 PM - 3:50 PM

Relocation Break

Participants are invited to use this time to return to the plenary session held in the main conference room.


3:50 PM - 5:00 PM

Investigator Insights 

Every year at MedCon, Investigators share insight on inspection trends observed. The FDA sends veteran device investigators to “tell it like it is” from their perspective. Use this friendly forum to prepare today for tomorrow.

Moderator:

  • Monica Wilkins, Divisional Vice President of Medical, Clinical, Quality and Strategic Support, Abbott

Speakers:

  • Ben Dastoli, Investigator, Medical Device Specialist, FDA

  • Laureen Geniusz, Investigator, Cincinnati District, FDA

  • Thomas Peter, Medical Device Specialist, FDA

  • Timothy Philips, Compliance Officer / Biomedical Engineer, FDA

  • Phil Pontikos, National Device Expert, FDA


Cincinnati Art Museum

5:45 PM - 8:30 PM

Annual MedCon Dinner – Cincinnati Art Museum

Network with FDA, speakers, committee members and peers, while touring one of the oldest museums in the United States. Its collection of over 67,000 works spanning 6,000 years of human history make it one of the most comprehensive collections in the Midwest and is sure to spark interesting conversation. The evening will be capped with a dinner.