Excellence in Quality Workshop
Chart Your Path to Continuous Improvement this November in Irvine, CA
Hosted by the Medical Device Innovation Consortium’s Advancing Quality Excellence Collaborative Community (AQEcc) and Edwards Life Sciences.
Workshop Details:
Thursday, November 14, 2024 | 7:30 a.m. – 5:00 p.m. PT | In-person
Edwards Life Sciences Corporate Campus | 1 Edwards Way, Irvine, CA 92614
$195.00 registration fee (breakfast and lunch provided)
About
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.
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
- Presented by Paul Sumner and Rob Becker
Jackie Torfin
CEO, Qlear Advisors
Kathryn Merrill
Global Quality Program Director, Medtronic
Pat Shafer
Managing Director, Healthcare, FTI Consulting
Rob Becker
Vice President, Quality, Edwards Lifesciences
Ravi Nabar
Senior Vice President, Quality & Regulatory Compliance, Compliance Group
Daniel Walter
Policy Analyst, FDA-CDRH
Amra Racic
Sr. Director Global Government Strategy MedTech, Veeva Systems
Marina Moses
Policy Analyst, FDA-CDRH
Erin Keith
Policy Analyst, FDA-CDRH
Andy Lee
Director, Software Quality, Edwards Lifesciences