Case for Quality–Elevating Impactful Investments in Quality
District Architecture, Washington, D.C.
The Case for Quality has helped medical device stakeholders elevate the standards for sustained, predictive practices that advance medical device quality and safety. This summit will provide exciting perspectives on the successes of the Case for Quality Collaborative Community highlighting the Voluntary Improvement Program (VIP), CAPA Improvement pilot (#makeCAPAcool), Leadership Engagement-Culture of Quality, Safe Space Electronic Recall Notification, Supply Chain Resilience Best Practices, Advanced Manufacturing, and Baldrige Pursuit of Excellence. 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.
CAPA Risk Based Framework – “The Rosetta Stone of CAPAs” by Steve Silverman, President, Silverman Group
Baldrige Framework – “Operational Excellence is not just for Breakfast” by Joyti K. Malhotra, Ph.D., Division Chief for National Programs and the Acting Division Chief for National Platorms for the Hollings Manufacturing Extension Partnership, National Institutes of Standards and Technology
Continuous Improvement- “POV-A VIP Participant’s View” by Mark Rutkiewicz, Vice President of Quality, Innovize
Championing a Culture of Quality – “The Vibes from the Top” by Loretta A. Cecil, former Executive Vice President, and General Counsel for Change Healthcare, Inc.
Digital Transformation in Manufacturing – “Automation and Beyond the Keyboard” by Zohair Mehkri, Director of Engineering, Flex
Recall Notification in the Digital Age – “Snail Mail Doesn’t Cut It: by Daniel Walter, Policy Analyst, Compliance and Quality, FDA-CDRH
Supplier Resilience-“What-No Ventilators or Paper Towels Anywhere?” by Scott Schein, Director, National Network and Supply Chain Programs, GENEDGE
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