1 Quality Engagement Forum Case for Quality Suzanne Fiorino, Program Manager
2 Welcome Introductions Purpose Program Overview Expectations
3 Introductions Name & Affiliation only; Bio s available in your handout
4 Purpose of Today s Meeting Provide Common Understanding of the Case for Quality work Share progress made to date in the various initiatives Obtain your thoughts & input for consideration for future programs
5 Case for Quality Broad Agency Agreement (BAA) Identify Project Manager Engage Participants Establish Forum Structure Host Monthly Forums Conduct Research Document Learnings Publish: White Papers, and Change Action Plan Infrastructure Implementation Deliverables Goal: Develop a better understanding of what changes are necessary to catalyze industry movement towards improved device quality. Strategy: Conduct research through Quality Engagement Forums of medical device industry stakeholders and summarize the findings from those interactions in a comprehensive Change Action Plan. Objectives: 1. Conduct research on Quality Maturity Models, 2. Create a venue for Quality Engagement Forums, 3. Create a list of key topics to be used to generate discussion and interaction during these sessions, 4. Develop a Change Action Plan summarizing the results.
6 MDIC Case for Quality Governance MDIC CfQ Steering Committee SC Roles / Responsibilities - Membership by Nomination & approval of non-fda SC members - No more than 2 members per represented organization - Total SC not to exceed 12 members MDIC CfQ Forum Members - Membership by application to MDIC - Capped at 42 members - No more than 2 members per represented organization MDIC Open Forum - Open to all interested parties - Limited only by technology capability - Oversees overall program and periodically reviews for any changes needed - Approve establishment of Working Group(s) - Communicate progress of program to interested stakeholders - Seek diverse representation to both SC and Forum Forum Roles / Responsibilities - Active participation in Forums and at least one Working Group - Commit human resources to Working Groups Roles/Responsibilities - Listen - Ask Questions - Contribute Ideas
7 2015 Schedule SC Forums March 24 th Washington, DC May 20 th Washington, DC July 21 st Washington, DC TBD TBD Open/Large Forums Virtual - TBD Virtual - TBD October 8 San Diego, CA [after AdvaMed] Working Groups Current Updates Updates Updates SC Reviews/ Approves New Working Groups Steering Committee Meetings Regular Forum Meetings Periodic Open Forum Meetings Working Groups meet and make progress between Forum Meetings
Agenda: Case for Quality Forum 3/24/15 Topic Speaker 8:00 8:15 am Welcome Steve Solomon Deputy Associate Commissioner for Regulatory Affairs, FDA Joe Sapiente Vice President Global Quality Operations Medtronic 8:15 8:45 am Program Overview, MDIC, & CfQ Research-Maturity Models Suzanne Fiorino Program Manager, MDIC (Johnson & Johnson) Bill Murray President and CEO Medical Device Innovation Consortium (MDIC) George Serafin National Managing Director Life Sciences and Healthcare Governance, Regulatory, and Risk Strategies 8 8:45 9:15 am Case for Quality Journey Jan Welch Acting Director, Office of Compliance, CDRH Joe Sapiente Donna Godward Chief Quality Officer Johnson & Johnson Medical Devices
Agenda: Case for Quality Forum 3/24/15 Topic Speaker 9:15 10:00 am Transparency Efforts Ann Ferriter Director, Division of Analysis and Program Operations 10:00 10:20 am Break - 10:20 11:15 am Critical to Quality 11:15 11:40 am Successful Practices 11:40 12:00 am Quality Measures Initiative Bill MacFarland Director, Division of Manufacturing and Quality Donna Godward Kim Lewandowski-Walker National Device Expert, Office of Regulatory Affairs Kristin McNamara Senior Advisor Office of Global Regulatory Operations and Policy 12:00 12:30 pm Lunch - 9 12:30 1:00 pm Ideation Captured at June 26, 2014 Forum Francisco Vicenty Chief Respiratory, Ear/Nose/Throat, General Hospital, and Ophthalmic Devices Branch Division of Manufacturing and Quality Office of Compliance Center for Devices and Radiological Health, US FDA
10 Agenda: Case for Quality Forum 3/24/15 Topic Speaker 1:00 1:15 pm Instructions Deloitte 1:15 2:30 pm Facilitated Break Out Sessions Deloitte 2:30 2:45 pm Break N/A 2:45 3:15 pm Report Out and Voting Deloitte 3:15 3:45 pm Assignments Deloitte 3:45 4:00 pm Feedback and Closing Remarks Steve Solomon Joe Sapiente
11 Expectations Dream Big Great Ideas Great Actions Across all Stakeholder Groups