9th Annual Medical Device Supplier Quality Assurance Conference

April 29-30, 2019 | Arlington, VA

Key Bridge Marriott

Download AgendaRegister Now

DAY TWO | TUESDAY, APRIL 30

8:30 REGISTRATION & WELCOME COFFEE

8:55 CHAIRPERSON’S OPENING REMARKS

9:00 MANEUVERING AN UNCERTAIN REGULATORY & QUALITY LANDSCAPE IN ASIAN MARKETS
Ensuring quality compliance with regulations in global markets proves complex as organizations face varying requirements and ever changing demands for devices. Specifically within Asia, certain countries are currently more challenging than others such as China, for which OEMs seek clarification on recent updates as well as insight into qualifying suppliers across the Asian region. With mandates and supplier capabilities evolving, quality assurance experts aim to properly interpret requirements in order to maintain global quality demands.

Jetzabeth Deliz, Quality Assurance Director, BD

 

FUNDAMENTALS OF ROBUST MEDICAL DEVICE SUPPLIER QUALITY MANAGEMENT
Quality teams revise supplier management programs as the company, suppliers, and the overall medical device industry evolves and changes, and with a greater focus on risk assessment, executives must ensure management approaches remain detailed and up-to-date. Dynamic programs are designed to operate throughout the entire product life cycle, from the early stages of collaborating with suppliers to discuss quality agreements and legal contracts, to developing a unique scoring system for distinct component types, and lastly, creating procedures to properly disengage suppliers. Throughout this multi-part module, participants will walk through the crucial elements that comprise a robust supplier quality management program and how industry peers are tackling the numerous steps.

9:30 CASE STUDY: TECHNICAL REQUIREMENTS FOR SUPPLIER AGREEMENTS

  • Request for comprehensive supplier proposals
  • Evaluate templates & industry standards
  • Technical traits of quality agreements

Kenneth Brown, Sr. Supplier Quality Engineer, GETINGE

 

10:00 COFFEE & NETWORKING BREAK

 

10:15 BREAKOUT GROUPS: ASSESSING MULTIPLE SUPPLIER SCORING MODELS

  • Detailed examination of various supplier scoring systems
  • Consideration of scoring structures & areas of improvement
  • Developing scorecard characteristics for specific suppliers

MODERATORS:
Shonte Pettiford, Quality Program Manager, ABBOTT

Ragini Ayengar, Sr. Manager, Supplier Quality Development – New Product Introduction, ILLUMINA

Brian Tucker, Supplier Engineer, COORSTEK MEDICAL

 

CASE STUDIES: SUMMARY OF SCORING MODEL DEVELOPMENT & SPECIFIC ATTRIBUTES
Following the small group discussion session, breakout group leaders will present brief case studies to showcase the process for establishing robust scoring systems and the significant aspects aligned with company priorities. Audience members will have the opportunity to ask detailed questions and share constructive critiques.

10:45 ABBOTT CASE STUDY
Shonte Pettiford, Quality Program Manager, ABBOTT

11:05 ILLUMINA CASE STUDY
Ragini Ayengar, Sr. Manager, Supplier Quality Development – New Product Introduction, ILLUMINA

11:25 COORSTEK MEDICAL CASE STUDY
Brian Tucker, Supplier Engineer, COORSTEK MEDICAL

 

11:45 LUNCHEON FOR ALL PARTICIPANTS

 

INDUSTRY CASE STUDIES: MANAGING SUPPLIERS RESPONSIBLE FOR VARIED TYPES OF COMPONENTS
Quality teams must manage a network of suppliers developing various components, including traditional material such as metal and plastic parts, chemical and medicinal units, as well as technology including GxP software for internal quality measuring and additional integrated software in the final product. The utilization of a wide range of suppliers involves careful consideration while establishing diverse methods to assess risk throughout qualification, validation, and monitoring stages. Different classes of suppliers will also require distinct scoring systems and audit practices.

  • Risk assessment for non-traditional suppliers
  • Supplier qualification & validation criteria
  • Scorecard attributes exclusive to supplier type
  • Designing audits contingent on component

12:45 CONTRACT MANUFACTURERS:
Darren Cooper, Global Supplier Quality Staff Engineer, BD

1:05 TRADITIONAL COMPONENT PARTS:
Edgar Cardoso, Senior Program Manager, Supplier Quality, MEDTRONIC

1:25 CHEMICAL/BIOLOGICAL SUPPLIERS:
Michelle Cunningham, Quality Manager, Global Supply Chain QA, ABBOTT

 

1:45 BREAKOUT GROUPS: REVIEW OF SUPPLIER MANAGEMENT TECHNIQUES DEPENDENT ON RISK PROFILE OF COMPONENT
With a wide range of parts for each device, quality assurance teams face unique challenges specific to individual supplier types, ultimately shaping the methods to manage each effectively. This peer-to-peer learning session allows participants to share hurdles and solutions exclusively applicable to distinct suppliers, ensuring a detailed approach to each component type and maximized take-away. To enable the exchange, the audience will break into smaller groups, focusing on a specific supplier group as listed below, with the possibility of adding further groups and categories as deemed necessary by the audience.

CONTRACT MANUFACTURERS:
Darren Cooper, BD

TRADITIONAL COMPONENT PARTS:
Edgar Cardoso, MEDTRONIC

CHEMICAL/BIOLOGIC SUPPLIERS:
Michelle Cunningham, ABBOTT

 

2:15 COFFEE & NETWORKING BREAK

 

2:45 FIRESIDE CHAT: MANUFACTURER PERSPECTIVE ON SUPPLIER QUALIFICATION STANDARDS
Quality teams assess component manufacturers on a range of characteristics to ensure capabilities align with OEM needs, however, with various groups of suppliers, executives coordinate distinct qualification measures for individual companies. Qualification standards must adjust for different levels of supplier risk as well as critical and non-critical components. While designing qualification processes involves time and resources, quality teams review industry approaches, discuss appropriate OEM demands, mandatory deliverables, and supplier documentation.

  • Best practices to assess a variety of supplier capabilities
  • Difference in qualifying critical vs. non-critical suppliers
  • Developing qualification standards in line with OEM needs

MODERATOR:
Tiffany Abrams, EDWARDS LIFESCIENCES

PANELIST:
Edgar Cardoso, MEDTRONIC

 

3:05 FIRESIDE CHAT: SUPPLIER PERSPECTIVE: PROCESS OVERSIGHT & VALIDATION EXCELLENCE
OEMs place significant importance on validated processes to ensure conformity and suppliers find it challenging to arrange validations without a standardized pathway throughout the industry. Although validation is of the utmost importance to ensure conformity during product development manufacturing, resources such as man power, time, and financial assets vary, making it difficult to adhere to detailed OEM demands. To mitigate constant OEM oversight, suppliers must manage systems with risk based techniques and align proper documentation to prove conformity and validation.

  • Standardizing requirements for supplier to validate processes
  • Supplier limitations & available resources to validate properly
  • Risk based approaches to ensure accurate supplier validation

MODERATOR:
Tiffany Abrams, EDWARDS LIFESCIENCES

PANELISTS:
Shibu Korula, COORSTEK MEDICAL

 

3:25 COMBINED ROUNDTABLE: SUPPLIER & OEM DELIBERATION ON QUALIFICATION & VALIDATION PROCESSES
Quality executives from OEMs and supplier companies recognize the collaborative efforts necessary to ensure product excellence, however, there can often be discrepancies between counterparts due to a lack of communication about extensive requests and partnership conditions. As suppliers seek further interpretation on qualification standards, OEMs shed light on reasoning for certain attributes and attractive qualities in a supplier. In addition, manufacturers require clarification on supplier procedures and specifics for seamless a validation process.

  • Manufacturer reasoning for supplier qualification standards
  • Communicating supplier requirements & validation efforts
  • Appropriate demands based on manufacturer/supplier abilities

MODERATOR:
Tiffany Abrams, EDWARDS LIFESCIENCES

PANELISTS:
Edgar Cardoso, MEDTRONIC

Shibu Korula, COORSTEK MEDICAL

 

3:45 CLOSING REMARKS & CONFERENCE CONCLUSION

Share This