Join us the day before the FDA/Xavier MedCon conference, for the Case for Quality Workshop, Tuesday, May 1, 2018, from 11:30am-4pm EST, at Xavier University. 

In 2011, CDRH launched the Case for Quality initiative in an effort to shift the focus of industry and FDA from one of compliance and enforcement to one of quality ownership, based on the concept that a focus on quality ownership will improve product quality and patient safety, while naturally resulting in compliance. As the Case for Quality work has progressed, FDA has continually engaged industry members through the Medical Device Innovation Consortium (MDIC), which is a public/private partnership established by Dr. Jeff Shuren (CDRH Center Director). Dr. Shuren has indicated that reductions in certain regulatory oversight (pre-market and post-market) will be granted to those demonstrating mature quality ownership.

Through MDIC, CDRH launched a pilot study in 2017 designed to test the effectiveness of a maturity model established through an MDIC working team of FDA and industry members. As the pilot nears the halfway point, CDRH would like to engage industry members in a workshop to discuss the Case for Quality:

  • Provide your input to FDA on the latest updates on the voluntary Case for Quality pilot study.
  • Discuss the benefits of the preliminary outcomes from the voluntary pilot study with FDA and your industry colleagues.
  • Engage with FDA and your industry colleagues to develop ways to help expand the applicability of the pilot.
  • Participate in developing the strategy for next steps.

As a primer to the Case for Quality Workshop at Xavier, it would be beneficial for attendees to listen to the February 27th MDIC Quarterly update webinar on the "CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program." Attendees will be in a better position to provide meaningful input to the FDA if the background is understood prior to joining us at Xavier.

Cost of Workshop:

  • If attending MedCon:
    • Industry: $495
    • Small Business, Startup, Self-Employed, Nonprofit, or Non-Xavier Academic: $249
    • FDA, Media, or Xavier Faculty/Staff: Free
    • If not attending MedCon:
      • Everyone: $595
      • Government, Media, or Xavier Faculty/Staff: Free
     

    Planning Your Trip

    For information on planning your trip (including information about the Cintas Center, hotel, airports, maps, and Cincinnati attractions), click here. For a printable parking pass the day of event for lot C2, click here.

     

    Agenda

    11:30 AM - 12:10 PM

    Networking Lunch


    12:10 pM - 12:15 PM

    Let's Make a Difference

    This purpose-driven workshop will lead you to actionable learning and implementation plans.

    Moderator/Speaker:

    • Marla Phillips, Director, Xavier Health, Xavier University

    12:15 PM - 12:45 PM

    FDA Update on the Case for Quality Voluntary Pilot Program

    • Current observations
    • Learning
    • What has worked, what hasn’t, what has been adjusted

    Moderator:

    • Stephanie Christopher, Program Director, Medical Device Innovation Consortium

    Speaker: 

    • Sean Boyd, Deputy Director for Regulatory Affairs, Office of Compliance, CDRH - FDA
    • Cisco Vicenty, Program Manager, Office of Compliance, CDRH - FDA
    • Bleta Vuniqi, Biomedical Engineer, Office of Compliance, CDRH - FDA

    12:45 PM - 1:35 PM

    Panel: Manufacturers' Experiences in the CDRH Pilot

    Among the questions to be answered:

    • Why did you participate?
    • What did you learn?
    • What surprised you?
    • Benefits beyond the CDRH regulatory benefits

    Moderator:

    • Stephanie Christopher, Program Director, Medical Device Innovation Consortium

    Panel: 

    • Kathleen L. Bardwell, Senior Vice President, Chief Compliance Officer, STERIS
    • Patrick Caines, Ph.D., M.B.A., Senior Director, Quality & Compliance, Baxter Healthcare
    • Stephanie Fossat-Dominguez, Director, Quality, Celo Nova Biosciences
    • Joe Sapiente, Vice President, Quality Assurance and Regulatory Affairs
      Hologic, Inc.

    1:35 PM - 1:50 PM

    Break


    1:50 PM - 2:35 PM

    Expanding the Scope of the Current Pilot Model and Requirements

    This small group discussion, which includes all attendees, will touch on:

    • Possibly expand participation in the pilot to companies who have OAI inspection outcomes
    • Brainstorm on how to leverage the maturity methodology to bring new innovators into the pilot program

    Moderator:

    • Stephanie Christopher, Program Director, Medical Device Innovation Consortium

    2:35 PM - 3:05 PM

    How the Pilot Fits into the Future of CDRH and Other Initiatives

    • Metrics collection and utilization
    • Submission modifications and trends at FDA
    • Digital health and FDA Pre-Check program

    Moderator:

    • Stephanie Christopher, Program Director, Medical Device Innovation Consortium

    Panel: 

    • Sean Boyd, Deputy Director for Regulatory Affairs, Office of Compliance, CDRH - FDA
    • Cisco Vicenty, Program Manager, Office of Compliance, CDRH - FDA
    • Bleta Vuniqi, Biomedical Engineer, Office of Compliance, CDRH - FDA

    3:05 PM - 3:55 PM

    Small Group Discussion: Potential Continuous Visibility

    FDA would like to explore with participants how to move beyond the "Snap shot in time" challenge that audits present, and move to a more advanced way for industry to continuously assess its operations and the quality of its products.

    Moderator:

    • George Serafin, National Managing Principal HC/LS, Compliance RiskGrant Thornton


    3:55-4:00

    Closing Remarks

    Moderator:

    • Marla Phillips, Director, Xavier Health, Xavier University


    Case for Quality Workshop Speakers