Day One Agenda
Monday, June 17

All times Central US

8:00   ZOOM SIGN-ON & VIRTUAL PROGRAM WELCOME
» Private & public text chat
» Interactive polling
» Tech check

8:20   OPENING REMARKS

8:30   FIRESIDE CHAT: EXPLORING THE UNDERLYING RATIONALE FOR FDA’S QMS RULE UPDATE
In order to fully address the rapidly evolving medical technology landscape, including highly sophisticated and innovative products, the need to update the FDA’s long-standing QMS rule became pressing. In addition, the FDA is one of the few regulatory authorities to recognize the importance of harmonization in the international setting, and the many benefits to the industry and patients alike. Through a targeted, unscripted discussion, panelists will share thoughts on the why and how behind the FDA’s decision to shift to updated requirements now, the value of aligning more closely with ISO 13485, and what to expect in the near future related to continuously optimizing quality and risk management processes.
Fidelma Sheerin, STRYKER
James Monroe, RHYTHMEDIX

9:00  PANEL DISCUSSION: PERFORMING A COMPREHENSIVE QSR VS. QMSR GAP ANALYSIS
• Understanding differences between QSR & QMSR
• Identifying terminology to be replaced or excluded
• Extending audit prep to cover PMS, supplier & risk management
• Harmonizing processes surrounding complaint records
Darrin Carlson, BRACCO MEDICAL TECHNOLOGIES
Aaron Snyder, ALLOTEX
Fidelma Sheerin, STRYKER

9:45  VIRTUAL NETWORKING & COFFEE BREAK

10:15   ESTABLISHING A TIMELINE FOR QUALITY MANAGEMENT SYSTEM UPDATES
• Outlining steps to reach compliance with QMSR
• Benchmarks for now to February 2026
• Importance of early adoption to monitor upgrades
• Planning for submissions scheduled for year-end 2025
Darrin Carlson, BRACCO MEDICAL TECHNOLOGIES
Jackie Jaskula, NATERA
Aaron Snyder, ALLOTEX

11:00   OPTIMIZING RISK MANAGEMENT STRATEGIES TO BOLSTER PRODUCT SAFETY & EFFICACY
• Embedding risk analysis into design conception
• Identifying & solving risks with design history
• Demonstrating activity & effort criteria to reviewers
Noel Butterworth, Sr. Program Manager
MEDTRONIC

11:45   ISO 14971 STANDARDS AS A GUIDE TO RISK MANAGEMENT UNDER QMSR
• FDA’s heightened focus on documentation of risk
• QMSR comparison to ISO 14971 requirements
• Building risk assessment at all stages of development
• Validating risk management procedures proactively
Eric Henry, Sr. Quality Systems & Compliance Advisor
KING & SPALDING

12:30   DAY ONE CONCLUSION

Day Two Agenda
Tuesday, June 18

All Times Central US

8:00   ZOOM SIGN-ON & VIRTUAL PROGRAM WELCOME
» Private & public text chat
» Interactive polling
» Tech check

8:20   OPENING REMARKS

8:30   PANEL DISCUSSION: DEEP DIVE INTO QUESTIONS PROPOSED IN QMSR REGULATION PREAMBLE
• Pros & cons to modifications of document vocabulary
• Influence when a regulation is or is not incorporated by reference
• Switching to another reference language in QMSR documents
• Impact of future revisions of ISO 13485 on QMSR
• Discussion on audience proposed areas of ambiguity
Imene Benachour, CELLULOPLAST PRODUCTION
Vincent Cafiso, CREO
Gary Hartman, FORMERLY WITH ASTRAZENECA
Samantha Blanco, VERILY LIFE SCIENCES

9:15  PANEL DISCUSSION: PROACTIVE APPROACH TO INSPECTION-READINESS AHEAD OF FDA QMSR RULE ADOPTION
• Expectations for inspections conducted in 2025 & 2026
• Challenges when internal audit records are open to inspection
• Cost-benefit analysis of independent reviewer without requirement
• Preparing supplier quality, PMS, & risk management for review
• Anticipating impact of QMSR on MDSAP program
Giacomo Cargnello, VAREX IMAGING
Josh Weibel, ARUP LABORATORIES
Gary Hartman, FORMERLY WITH AZTRAZENECA
Samantha Blanco, VERILY LIFE SCIENCES

10:00   VIRTUAL NETWORKING & COFFEE BREAK

10:30  APPLICATION OF RISK MANAGEMENT PRACTICES TO SOFTWARE QUALITY ASSURANCE
• Best practices in quality system management for software development
• Documentation of software versions & updates for risk analysis
• Addressing environment factors in product validation & verification
Ephrat Most, Sr. Quality Systems Manager
MEDTRONIC

11:00   PANEL DISCUSSION: OPPORTUNITIES & LIMITATIONS IN THE ESTABLISHMENT OF SUPPLIER QUALITY AGREEMENTS
• Challenges with current implementation of SQAs
• Instilling follow-up actions into documentation
• Management & organization of SQA portfolio
• Impact of supplier audits being open to FDA inspection
• A closer look at specifications in emerging markets
Imene Benachour, CELLULOPLAST PRODUCTION
David Festa, THERMO FISHER SCIENTIFIC
Gary Hartman, FORMERLY WITH AZTRAZENECA

11:45  EXTENDING QUALITY ASSURANCE TO EMPLOYEE TRAINING PROGRAMS
• Monitoring ongoing training schedules for new & existing employees
• Ensuring job functions are aligned with assigned trainings
• Documentation & validation of training completion
• Promoting a culture encouraging continuous improvement
Josh Weibel, Quality Manager, Pharma Dx
ARUP LABORATORIES

12:15  CLOSING REMARKS & PROFESSIONAL EDUCATION COURSE CONCLUSION