Plenary

How You Can Influence and Support Leadership and a Quality Culture in your Organization

Friday, April 24, 2026

8:05 AM - 9:05 AM East Coast USA Time

Location: Regency Ballroom - 3rd Floor

Moderator(s)

Kim Trautman

Expert
Medical Device, IVD and Combo Product Expert

Speaker(s)

Philip Desjardins

Partner
Arnold Porter
Heather Howell

Lead Quality Systems Auditor
Fresenius Medical Care
Jennifer Paine

Chief Quality Officer
Johnson & Johnson
James Wabby

Global Head, Regulatory Affairs (CoE) - Emerging Technologies, Devices, and Combination Products & Volwiler Senior Research Industry Fellow - Regulatory Science,
AbbVie, Inc.

Every employee of a medical device company can influence quality culture! Quality isn't just a policy and is not a specific regulatory requirement; it's a core value influencing how people think and act.

A culture of quality is a shared organizational mindset where everyone, from top leadership to front-line staff, prioritizes and actively pursues excellence, continuous improvement, and customer satisfaction by embedding quality values into daily behaviors, decisions, and processes, going beyond mere compliance.

This session will discuss some areas where companies are overtly trying to increase awareness of quality culture and challenges sometimes in messaging to leadership. The session will include a short case study to stimulate discussions on how to make quality culture a fundamental part of your company's spirit and competitive advantage through shared responsibility.