Case for Quality Collaborative Community Workshop

 // Events

October 9  

Since it began in 2011, the Case for Quality has helped medical device stakeholders elevate the standards for sustained, predictive practices that advance medical device quality and safety.

This event will provide exciting perspectives on the successes of the MDIC Case for Quality Collaborative Community (CfQcc) highlighting the CAPA Improvement pilot (#makeCAPAcool) and Leadership Engagement-Culture of Quality. 

Attendees will be inspired by the advances, impacts, and ROI from CfQcc participation, including enterprise transformation towards higher quality medical devices, improved patient safety, and greater investment returns.

Join us to learn through hands-on practical ways to adopt the recently released CAPA risk-based framework and be inspired to elevate to a culture of Quality through this interactive in-person workshop. Small and medium sized organizations serving the healthcare ecosystem will especially benefit from experiencing strategic and practical adoption techniques from the innovators that lived and learned the lessons and successful surmounted the summit of holistic, integrated Quality.

Instructors / Panelists

Jackie Torfin, Partner, QRX Partners

Daniel Buehner, Vice President, Head of Plant Quality, Edwards Life Sciences

Daniel Walter, Policy Analyst, FDA, CDRH

Zillery Fortner, Product Advisor, QA/RA Life Science, Honeywell

Rhonda L. Mecl, Deputy Program Director, FDA, OMDRHO

Karen Peifer, Chair MN ASQ Biomedical Consortium, American Society for Quality

Lynn Roberts, Founder, OptiQ Consulting

Pat Shafer, Regulatory and Quality Practice Leader, FTI Consulting

Ravi Nabar, Steering Committee Chairperson, Case for Quality Collaborative Community


Value Story, Successes, and Lessons Learned 

7:30 – 8:00 AM  |  Breakfast & Registration

8:00 – 8:15 AM  |  Welcome

8:15 – 9:55 AM  |  Championing a Culture of Quality: “Beyond a Breakfast Conversation”

  • The culture mindset of compliance-only leads to Quality devices persists within the medical device industry. Hear from and converse with thought leaders on the importance and challenges of elevating organization culture to one of Quality excellence from a variety of perspectives.
  • This inspiring session will bring together industry thought leaders to engage in a conversation focusing on enterprise organizational quality culture. Explore various challenges facing professionals and companies that directly impact elevating quality culture to the next level and as we offer personal insights with successful best practices. Drawing from the Leadership Engagement Playbook and their firsthand experiences, experts will have an enriching dialogue as part of their multifaceted strategy development for implementing best practices, regardless of an organization's stature. Attendees can expect to gain valuable knowledge and tactical advice to navigate the evolving landscape of quality culture management. This group is dedicated to enhancing quality throughout the entire product lifecycle, and their efforts will serve as a demonstration to the importance of fostering a culture of quality within organizations. By emphasizing the significance of leadership engagement and sharing innovative methodologies, attendees will be provided with the tools and insights needed to drive positive change and achieve excellence in quality management.

9:55 – 10:15 AM  |  Networking Break

10:15 – 11:55 AM  |  Make CAPA Cool – A Risk Based Framework: “The Rosetta Stone of CAPAs”

  • Are you interested in closing Corrective and Preventive Actions (CAPAs) in 60 days or less, leaving more time to focus on improvements and problem solving? What about finding out why almost 90% of participants were satisfied with their experience using a transformative, risk focused CAPA framework? Join us in this follow-up to the impactful #makeCAPAcool pilot study and White Paper release to find out the answers to these questions and much more! 
  •  Led by MDIC’s Case for Quality Collaborative Community, this initiative transforms the corrective and preventive action (CAPA) process for medical devices by taking a risk-based approach, rather than the traditional resource-draining one-size-fits-all CAPA method. Featuring experts from the pilot study, industry and FDA, this workshop will provide in-depth details of the risk focused CAPA framework and discuss successes, lessons learned, and adoption approaches that elevate from the challenging traditional CAPA processes and why this framework is the Rosetta Stone of CAPA. Allow this #makeCAPAcool session to equip you with the tools to revolutionize CAPA practices and achieve better outcomes in medical device quality and safety.

11:55 AM – 12:00 PM  |  Closing Remarks

Event Details

Date & Time: 

November 14, 2023

7:30 AM - 12:00 PM CST 


Medical Alley
4150 Olson Memorial Hwy.
First Floor Training Center
Golden Valley, MN 55422


Medical Alley Partner Ticket - $75
Non-Partner Ticket - $99

Not sure if you are a partner? Search for your company on our partner directory here. If your company is a partner, YOU are a partner!

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