13th Annual
Medical Device Supplier Quality Assurance Conference
March 25-26, 2025 | Arlington, VA
Hilton Alexandria Mark Center
Assessing The Impact of New FDA Guidances While Navigating Evolving Medical Device Manufacturing Landscape and Unforeseen World Events to Ensure Uninterrupted Supplier Quality
Robert Labaczewski
Director, Device Quality
BRACCO DIAGNOSTICS
Randy Gage
Senior Supplier Quality Engineer
BD
Ariel Seeley
FDA Medical Device and Digital Health Attorney
MORGAN, LEWIS & BOCKIUS
Justin McCabe
Operations Manager
MEDACCRED
Matthew Boyle
Senior Director of Supplier Quality, Radiology Devices
BAYER
Imene Benachour
Business Development Manager
CELLULOPLAST
Christine Wahba
Senior Regulatory Affairs and Quality Assurance Specialist MEA
ALIGN TECHNOLOGY
Harlan Grossman
Senior New Product Development Supplier Quality Engineer
W. L. GORE
Mahnu Davar
Partner
ARNOLD & PORTER
Veronica Trejo
Senior Supplier Quality Engineer
TELEFLEX
Ravi Nabar
Industry Expert- Supplier Quality
Shahwer Jahan
Manager, Quality Systems, Medication Management Solutions
BD
Tony Sapp
Manager, Quality Assurance/Regulatory Affairs
KLOWEN ORTHO
David Festa
Director, Corporate Quality
THERMO FISHER SCIENTIFIC
Scott King
Senior Director, Regular and Quality
PACIFIC BIOSCIENCES
Jose Montero
Senior Supplier Quality Engineer
TERUMO CARDIOVASCULAR
8:00 REGISTRATION & WELCOME COFFEE
8:50 CHAIRPERSON’S OPENING REMARKS
9:00 QUALITY AGREEMENT MANAGEMENTS AND THE NEW REGULATORY PARADIGM
• Regulatory requirement for supplier agreements
• Understanding the constructs of supplier agreement
• Implementation of the supplier agreement across the supply chain
Ravi Nabar, Industry Expert- Supplier Quality
David Festa, Director, Corporate Quality
THERMO FISHER SCIENTIFIC
9:45 OVERCOMING SUPPLY CHAIN CHALLENGES: STRATEGIES FOR BUILDING RESILIENCY
• Addressing COVID’s impact on supply chains and buying patterns
• Understanding stringent regulatory requirements and its impact
• Tackling quality issues leading to manufacturing delays and recalls
• Geopolitical and trade considerations and its effect on supply
• Export and import constraints delaying the timely delivery of devices
Christine Wahba, Senior Regulatory Affairs and Quality Assurance Specialist MEA
ALIGN TECHNOLOGY
10:30 COFFEE & NETWORKING BREAK
11:00 UNPACKING FDA’S FINAL RULE TO REGULATE LABORATORY DEVELOPED TESTING SERVICES AS MEDICAL DEVICES
• Takeaways from FDA’s final rule on laboratory-developed tests
• Examining opportunities and methods for better supplier efficiency
• Regulatory and technical supplier quality assurance considerations
• Investigating possible legislative action over the final LDT rule
• FDA’s targeted enforcement discretion for certain test categories
Scott King, Senior Director, Regular and Quality
PACIFIC BIOSCIENCES
11:45 RISK MANAGEMENT AND SUPPLIER QUALITY ASSURANCE: RISK-BASED METHODOLOGIES TO MEDICAL DEVICE DESIGN AND QUALITY PROCESSES
• Identifying characteristics related to safety based on intended use
• Assessing risk control, safe design, and protective measures
• Considering risks to determine whether benefits outweigh risks
• Gaging the benefits of applying a risk-based approach in a QMS
• Risk assessment and backup plans to facilitate demands
Harlan Grossman, W. L. GORE
Randy Gage, BD
12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES
1:30-3:15 SESSION SERIES: SUB SUPPLIER CONTROL AND QUALITY ASSURANCE
1:30 Part 1: Stringent Oversight of Sub-Supplier Management Operations
• Decoding components linked to supplier’s material supply chains
• Inclusion of sub-supplier standards in quality agreements
• Establishment of communication channels with sub-suppliers
• Auditing sub-supplier production locations to ensure compliance
• Diverse approaches to manage quality agreements in sub-supplier
• Sub-supplier oversight and regulation compliance assurances
David Festa, THERMO FISHER SCIENTIFIC
Justin McCabe, MEDACCRED
2:25 Part-2 Supplier Qualification and Performance Monitoring
• Addressing terms in your quality agreement with tier 1 suppliers
• Ensuring tooling and assets are being managed at the sub-tier
• Addressing challenges and risks raised by sub-tier suppliers
• Supply chain considerations when qualifying the supplier
• Ongoing supplier monitoring and audits of tier 1 and sub-tiers
Matthew Boyle, BAYER
3:15 COFFEE & NETWORKING BREAK
3:45 KEY TAKEAWAYS INTO FDA’S FINALIZED RULE INCORPORATING ISO 13485 INTO QMSR
• Understanding FDA’s Finalized Rule for Enterprises
• Addressing why FDA is harmonizing QSR and ISO 13485
• Examining the global impact of the new finalized rule
• Compliance considerations with the new regulation
• Strategies for companies to prepare for future inspections
Ariel Seeley, FDA Medical Device and Digital Health Attorney
MORGAN, LEWIS & BOCKIUS
4:45 Closing Remarks & End of Day 1
Day Two Agenda
Wednesday, March 26
8:00 REGISTRATION & WELCOME COFFEE
8:20 CHAIRPERSON’S OPENING REMARKS
8:30 NEW PRODUCT DEVELOPMENT AND SUPPLIER QUALITY ASSURANCE: EXAMINING CHALLENGES WHEN BRINGING PRODUCTS TO MARKET
• Intellectual property protection considerations for companies
• Analyzing challenges relating to the cost of development
• Quality control challenges for new product development
• Ensuring suppliers meet standards when products come to market
Imene Benachour, Business Development Manager
CELLULOPLAST
9:15 PANEL DISCUSSION: FUTURE TRENDS AND CONSIDERATIONS FOR MEDICAL DEVICE SUPPLIER QUALITY
• Navigating and complying with regulations
» FDA (U.S.)
» EMA (Europe)
» ISO standards
• Ensuring products meet regulatory criteria for market entry
• Managing regulatory submissions and approvals
• Staying current with evolving regulations and guidelines
• Strategies to help maintain compliance with evolving regulations
• Ways AI can improve quality, increase productivity, and reduce time to market
• Ways digital transformation is shaping medical device quality management
• How to improve audit preparation using modern Quality Management Systems
• Strategies to managing Supply Chain Risk
Jose Montero, TERUMO CARDIOVASCULAR
Justin McCabe, MEDACCRED
Robert Labaczewski, BRACCO DIAGNOSTICS
Ravi Nabar, Industry Expert- Supplier Quality
10:15 COFFEE & NETWORKING BREAK
10:45-12:15 SESSION SERIES: CHANGE MANAGEMENT FOR MEDICAL DEVICES
10:45 Part 1: Practices for Transition Phases Regarding Supplier Quality Assurance
• Surveying supplier quality change processes involving procedures
• Overseeing pre-market and post-market product design changes
• Real tactics to prevent panic when incorporating the changes
Robert Labaczewski, Director, Device Quality
BRACCO DIAGNOSTICS
11:30 Part 2: Prioritizing Changes and Working with Companies Amid Resources
• Learning to prioritize changes according to the impact
• Patient and product functionality considerations
• Manufacturing activities considerations
• Managing change in large and small companies amid resources
• Considering the importance of classifying changes by necessity
Jose Montero, Senior Supplier Quality Engineer
TERUMO CARDIOVASCULAR
12:15 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES
1:15 Closing Remarks & End of Day 2
Previous Attendees Include:
Director of Supplier Quality, ABBOTT
Director, Quality Assurance, ABBOTT
Director Supplier Management and GCP Audit, ABBVIE INC.
Senior Supplier Quality Engineer, ABIOMED INC.
Supplier Quality Engineer, ACELL INC.
Associate Director, Quality, ALLERGAN
Global Director, Quality Assurance & Regulatory, ARTHREX
Manager, Supplier Quality, Global Quality, BAXTER
Supplier Quality Assurance Associate Director, BD
Director, Supplier Quality Assurance, BOSTON SCIENTIFIC
Supplier Quality Assurance Engineer, COOPER SURGICAL
Global Director- Supplier Development, DANA INCORPORATED
Senior Supplier Quality Manager, DEPUY SYNTHES
Principal Quality Engineer, EDWARDS LIFESCIENCES
Supplier Quality Engineer, EXACTECH INC
Quality System Specialist, FOOD & DRUG ADMINISTRATION
Vice President of Global Quality and Regulatory, FLEXTRONICS
Director, Supplier Quality, FRESENIUS KABI
Director Supplier Engineering, FRESENIUS MEDICAL CARE
Associate Director of Supplier Quality, DIOSYNTH BIOTECHNOLOGY
Quality Assurance and Regulatory Affairs Director, GE HEALTHCARE
Senior Director, Supplier Quality, ILLUMINA
Director Quality Engineering, INSULET CORPORATION
Director of Supplier Quality, JOHNSON & JOHNSON
Supplier Quality Engineer, KCI MEDICAL
Manager, Supplier Quality, LIFECELL CORPORATION
Director, Quality Assurance, MALLINCKRODT
Director, Supplier Quality, MEDTRONIC
Associate Director, Device Quality, MERCK GROUP
Senior Director, Quality Operations, MERZ
Supplier Quality Engineer, MICROPORT ORTHOPEDICS
Senior Supplier Quality Engineer, NEOTRACT
and many more
Who should attend:
Executives working within medical device corporations that will find this program of greatest relevance are those currently working to maintain compliance with product regulations in the US, and anticipating implementation of new FDA and global regulations, as well as ensuring suppliers provide products that meet these regulations. Job titles of those executives that will find this program to be most applicable to the job function include:
• Supplier Quality Assurance
• Supplier quality Engineers
• Supplier Quality Management (SQM)
• Quality Assurance
