7:45AM - 8:30AM

Breakfast

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


8:30AM  -  9:00AM

Let's Make a Difference!

Welcome to MedCon, 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), Xavier Health
Speakers: Steven Barber, FDA; Marla Phillips


9:00AM - 9:45AM

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, ETHICON
Speakers: Dennis Hahn


9:45AM - 10:05AM

Break


10:05AM - 10:50AM

Center Director Corner: Strategic Priorities for 2017 and Beyond

Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH) will share strategic priorities related to protecting public health, including collaborative activities shared with industry on the balance of safety, efficacy, quality, access and innovation. Dr. Shuren will be presenting remotely via video, and questions can be asked by participants via video for a face-to-face interaction with Dr. Shuren.

Moderator: James O’Reilly, University of Cincinnati
Speakers: Jeff Shuren, FDA


10:50AM - 11:35AM

Office of Compliance Strategic Priorities

Director Robin Newman will outline the top priorities for CDRH Office of Compliance, the Case for Quality progress, and other emerging issues. Learn how these priorities can impact you.

Moderator: Gina Brackett, FDA
Speakers: Robin Newman, FDA


11:35AM - 12:30PM

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 on the following topics:

  • Premarket Review Process
  • 510(k) Modifications – When to Submit
  • Purchasing Controls
  • Case for Quality Metrics

12:30PM - 12:35PM

Conference Day 1 Milestone: Your Learning put into Action

Speaker: Jim Wulfeck, Complete Mastery


12:35PM - 1:20PM

Update from the Office of Device Evaluation

New Office Director, Dr. John Sheets, will summarize ODE accomplishments and activities, as well as discuss the recent guidance documents that significantly impact the premarket review process.

Moderator: Phil Phillips, Phillips Consulting Group
Speakers: Angela Kreuger, FDA


1:20PM - 2:05PM

FDA Insight on the 510(k) Modifications Guidance

FDA will provide an overview and insight on the August 2016 draft FDA Guidance, “Deciding When to Submit a 510(k) for a Change to an Existing Device.” Hear FDA discuss the history of the 510(k) guidance and provide  an update on the comments received to date.

Moderator: Steve Binion, BD
Speakers: Michael Ryan, FDA


2:05PM - 2:25PM

Break


2:25 PM - 5:00 PM

Track 1
510(k) Modifications: To Submit or Not to Submit?

A panel composed of FDA and industry experts will address case studies on device modifications: Is a 510(k) needed or not? If not, why not? What is the appropriate documentation? Learn more about your options for not submitting a 510(k), best practices for documentation, and what FDA will look for during an audit.

Moderator: Steve Binion, BD
Speakers: Steve Niedelman, King & Spalding; Phil Phillips, Phillips Consulting Group; Phil Pontikos, FDA; Heather Rosecrans, Greenleaf Health; Michael Ryan, FDA; Angela Kreuger, FDA; April Veoukas, Abbott

Track 2
Your Contract Manufacturer Received a Warning Letter. What Now?

Original Equipment Manufacturers (OEM) and Contract Manufacturers (CM) will share challenges and successful practices in managing a Warning Letter given to the CM. Participants will work thorough mini-case studies on solutions for real world scenarios related to CM/OEM partnerships. OEM will also share successful practices in evaluating and selecting CM partners, and proactively avoiding misunderstandings and issues.

Moderator: Gina Brackett, FDA
Speakers: Francis Blacha, Eli Lilly; Michael Mascali, VWR; Patricia Murphy, BSI Group America



5:45PM - 8:30PM

Keynote Dinner

Anderson Pavilion

Anderson Pavilion

Recognizing that so many of us are impacted and challenged by a world of constant change, Keynote Speaker Joe Sapiente (Vice President of Hologic; former Vice President of Medtronic) will paint a different picture for our dinner guests; a picture of opportunity and growth. Joe will share insights he has gained throughout his career journey that will help you focus on, and appreciate, the value of every experience you have. This keynote address is a refreshing reminder of what is important in life.

Don’t miss this opportunity to join your colleagues for a relaxing evening and enlightening keynote dinner at Anderson Pavilion (Smale Park) along the Ohio River.

Speakers: Joe Sapiente, Hologic