The FDA’s new Quality Management System Regulation (QMSR), effective February 2, 2026, represents the most significant shift in U.S. medical device quality requirements in more than three decades. By incorporating ISO 13485:2016, QMSR reshapes expectations for documentation, risk management, supplier oversight, and inspection readiness. This session will break down what the transition from QSR to QMSR means for quality leaders and how organizations can prepare.
Attendees will learn how to:
- Interpret the key regulatory changes and their operational impact;
- Strengthen risk management and documentation practices under the new framework;
- Align people, processes, and technology to build a future-ready QMS;
- Support cross-functional teams through the transition;
- Apply lessons learned that benefit both medical device and pharmaceutical environments
This presentation provides practical, actionable guidance for quality professionals navigating the evolving regulatory landscape in 2026 and beyond.
Speaker Bio: Shireen Yalda is a Senior Manager at Eurofins Pharma Bioanalytical Services with deep expertise in GMP manufacturing, GCP, GLP, contract services, and global regulatory compliance. She specializes in Quality Management Systems, Lean Six Sigma, and large-scale organizational transformation across pharmaceutical and biotech environments. Shireen has led major QMS modernization initiatives, built high performing quality organizations, and collaborated with global regulatory bodies to elevate compliance, operational excellence, and long term quality culture.
She currently serves as Vice Chair of the ASQ St. Louis Section, where she leads strategic programming, speaker engagement, and cross-section collaboration. Known for her practical, people-centered approach, Shireen focuses on aligning teams, processes, and technology to drive sustainable quality outcomes and reduce operational risk.