Excellence in Quality Workshop: Irvine, CA

Higher Quality: Charting the Path to Continuous Improvement

November 14, 2024 | 7:30AM – 5:00 PM PT
Edwards Life Sciences Campus
1 Edwards Way, Irvine, CA 92614

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 risk-based framework methodology (#makeCAPAcool), Championing a Higher Culture of Quality, Continuous Quality Improvement (VIP and ASC) leading to unique regulatory flexibilities, and featuring the utilization of Artificial Intelligence and Machine Learning for higher Quality Decisions and Management. 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.

MDIC Excellence in Quality Workshops are a unique opportunity to learn adoptable cutting-edge practices to maximize the impact of investing in quality across your total product lifecycle. Participants will be guided by industry experts and thought leaders through examinations of enterprise transformation, enhanced patient safety, and increased returns—all through the lens of the most advanced approaches to elevating quality.

The workshops will also provide opportunities to network with peers from companies at all phases of development, explore personal use cases to bring back real solutions, and discover the empowerment of engaging with the Case for Quality Collaborative Community. These unique events will home in on strategic and practical adoption techniques in hands-on workshops led by innovators in successfully having surmounted the summit of holistic, integrated quality. Participants will be inspired by a dynamic line-up of speakers and panel presentations connecting the threads between elevating Quality and patient safety.

Breakfast and lunch will be provided with ample networking time to participants. We look forward to hosting you this November in Irvine, CA!

Workshop Agenda

7:30 – 8:00 AM | Continental Breakfast

8:00 – 8:15 AM | Welcome

Presented by Paul Sumner and Rob Becker

8:15 – 9:55 AM | Championing a Culture of Quality

Explore how to elevate quality culture beyond compliance. Engage with industry leaders to discuss challenges, best practices, and leadership engagement strategies to foster a culture of quality. Includes panel discussions, case studies, and breakout sessions.

9:55 – 10:10 AM | Networking Break

10:10 – 11:50 AM | Make CAPA Cool – A Risk-Based Framework

Learn about transforming Corrective and Preventive Actions (CAPA) with a risk-based approach. Gain insights from industry and FDA experts on improving CAPA processes and outcomes. Includes interactive discussions, case studies, and group activities.

11:50 AM – 1:00 PM | Lunch

1:00 – 2:40 PM | Elevating Excellence Through Continuous Improvement

Discover the benefits of continuous improvement through the Voluntary Improvement Program (VIP). Experts share lessons learned, success stories, and tools for driving organizational and product quality improvements. Includes panels, practical case reviews, and mentorship.

3:00 – 4:40 PM | Accelerating Quality Excellence: CSA for AI/ML Enhanced QMS

Explore how to leverage CSA (Computer Software Assurance) for AI/ML in Quality Management Systems. Participate in interactive use cases and gain insights into critical thinking for technology adoption. Concludes with an executive panel discussion on the value of CSA.

4:40 – 4:50 PM | Workshop Closing Remarks