DAY ONE | MONDAY, APRIL 29
8:00 REGISTRATION & WELCOME COFFEE
8:50 CHAIRPERSON’S OPENING REMARKS
Steve Niedelman, Lead Quality Systems & Compliance Consultant, KING & SPALDING
9:00 ICE-BREAKER: SUPPLIER SCORECARD ATTRIBUTES & BENCHMARKING SYSTEMS
When working with a variety of suppliers, such as component, software, or chemical, OEMs utilize varying supplier scoring methods to audit unique attributes, while employing methods ranging from checklists to robust online databases. This opening ice-breaker will kick off the conference with the chance for all participants to meet new attendees and connect through short, engaging discussions. In this interactive session, participants are encouraged to share perspectives on key insights into supplier scoring system methods. Additionally, delegates will have the opportunity to build contacts with industry peers, kicking off the event networking platform.
Arpita Misra, Supplier Quality Assurance Engineer, COOPERSURGICAL
9:15 PANEL: STRENGTHENING PARTNERSHIPS BETWEEN SUPPLIER QUALITY ASSURANCE & PROCUREMENT TEAMS
In order to form strong cooperation between quality assurance and pro¬curement teams, executives must collaborate effectively on business decisions affecting the entire supply chain as well as explain function capabilities and limitations. Many OEMs are applying integrated methods to qualify suppliers with higher quality standards from the beginning of the relationship, insisting sourcing teams communicate quality requests in initial conversations. With both FDA and international requirements focusing heavily on risk based approaches to supplier management, pro-curement teams need to reassess liabilities and risk while sourcing for components and suppliers.
- Procurement expectations of supplier quality teams
- Supplier relationships with procurement vs. quality
- Integrating quality expectations during initial supplier contact
- Risk based approaches to sourcing & procurement
MODERATOR: Steve Niedelman, KING & SPALDING
PANELISTS: David Vazquez, BD
Leslie Cianella, THERMO FISHER SCIENTIFIC
Fernando Gonzalez, QUEST DIAGNOSTICS
10:00 COFFEE & NETWORKING BREAK
MULTI-PART MODULE: DEEP DIVE INTO THE MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP) INDUSTRY CASE STUDIES ON MDSAP AUDIT PARTICIPATION & BEST PRACTICES
With many companies participating in the MDSAP and completing audits, the industry has gained a better understanding of challenges throughout the audit process, as well as employable solutions. As the MDSAP evaluates compliance based on multiple touch points for supplier quality throughout the product lifecycle, OEMs and suppliers must plan for process oriented audits, as opposed to the more traditional checklist audit procedure. Through these short and incisive case studies presented by peers, delegates will have the opportunity to hear about successful MDSAP audits from an insider perspective and learn about best practices to ensure program compliance.
10:15 FDA PERSPECTIVE ON THE PROGRESSION OF MDSAP & SUPPLIER IMPLICATIONS
- Insight on status of the MDSAP program
- Address supplier controls within MDSAP
- Prospective implications for manufacturers
- CDRH reorganization implications for suppliers
Isabel Tejero, MD PhD, Lead Consumer Safety Officer, FDA
10:45 BOSTON SCIENTIFIC CASE STUDY
Rachel Borchers, Supplier Quality Manager, BOSTON SCIENTIFIC
11:15 THERMO FISHER SCIENTIFIC CASE STUDY
Paul Chiappetta, Director, Quality Systems and Compliance, THERMO FISHER SCIENTIFIC
11:45 PANEL: MDSAP & ISO 13485:2016 GAP ANALYSIS FOR SUPPLIER QUALITY AUDITS
Although MDSAP was developed with consideration for ISO 13485:2016, significant differences in compliance requirements do exist between the program and the guidance. Quality executives must maintain awareness of audit discrepancies to ensure correct procedures are followed accordingly. Reviewing the specifics of the MDSAP and ISO 13485:2016 to determine processes and documentation requirements unique to each will arm quality teams with the knowledge necessary to ensure a smooth auditing process.
- Analyzing differences between MDSAP & ISO 13485:2016
- OEM preparation for differing supplier quality audits
- Common challenges & solutions unique to MDSAP audits
MODERATOR: Steve Niedelman, KING & SPALDING
PANELISTS: Tiffany Abrams, EDWARDS LIFESCIENCES
Rachel Borchers, BOSTON SCIENTIFIC
Paul Chiappetta, THERMO FISHER SCIENTIFIC
12:30 LUNCHEON FOR ALL PARTICIPANTS
MULTI-PART MODULE: REVIEW & ANALYSIS OF ISO 13485:2016
1:30 REGULATORY CLARIFICATION ON RISK ASSESSMENT WITHIN ISO 13485:2016 FRAMEWORK
As ISO 13485:2016 places considerable value on risk assessment, OEMs seek additional interpretation on regulatory expectations regarding risk based application approaches for partnering with suppliers and establishing quality requirements. To ensure supplier excellence and examine each component adequately, OEMs must create unique validation traits for varying risk classifications, as well as maintain auditing efforts during the partnership lifecycle by periodically reevaluating suppliers in accordance to ISO 13485:2016. Medical device manufacturers must also employ risk based procedures for recording changes in processes and supplier sourcing.
- Differentiating risk assessments based on supplier classification
- Requirements for purchasing controls & change management
- Conducting continuous risk based supplier evaluations
Dennis Gucciardo, Partner, HOGAN LOVELLS
2:15 CASE STUDY: IMPLEMENTING EFFECTIVE RISK BASED SUPPLIER MANAGEMENT PROGRAMS
In order to comply with ISO 13485:2016 and remain up to date with industry trends, quality assurance teams are amending quality management systems to accommodate risk based approaches to supplier classification, purchasing and procurement. Quality executives must develop supplier management programs to account for the ISO 13485:2016 control requirements regarding risk based approaches for regulating outsourced processes, in addition to incorporating dynamic reevaluation audits. This industry case study will explore one manufacturer’s progress to design a successful and fully compliant supplier management program through risk based endeavors.
- Risk consideration throughout supplier management procedures
- Risk based supplier assessments prior to outsourcing processes
- Timelines & best practices to continuously reevaluate suppliers
Scott Van Ells, Supplier Quality Assurance, WL GORE & ASSOCIATES
3:00 COFFEE & NETWORKING BREAK
MULTI-PART MODULE: EVALUATION OF THE EUROPEAN UNION MEDICAL DEVICE REGULATION (EU MDR)
3:30 NOTIFIED BODY INTERPRETATION OF EU MDR IMPACT ON SUPPLIER QUALITY
OEMs operating within the EU face stricter requirements under the MDR, including ensuring total regulatory conformity for technologies throughout each stage of product development. Although process and component design files are considered the intellectual property of the supplier, OEMs must obtain complete design dossier submissions under the MDR. In order to continue processing devices and maintain compliance with EU MDR, manufacturers will likely need to obtain ownership of the component or process design.
- Demonstrating regulatory conformity throughout product development
- Clarification on ownership of supplier components & process designs
- Expectations of third parties & required supplier documentation
Tamas Borsai, Division Manager, MHS, TÜV SÜD AMERICA
4:15 CONDUCTING ASSESSMENTS & ASSIGNING APPROPRIATE LEVEL OF RISK TO SUPPLIERS
OEMs modify supplier assessments and develop distinct controls depending on the specific level of risk. Categories of risk not only vary based on suppli¬er type, such as chemical, metal, or plastics, but also on the precise material utilized throughout the manufacturing process or end product, requiring OEMs to provide appropriate and correct assignment of risk. Additionally, quality teams consider differences in risk for critical and non-critical com¬ponents and the effect on conducting supplier assessments.
- Determining critical vs. non critical components
- Qualifying suppliers based on assigned level of risk
- Innovative methods to conduct supplier assessments
Tiffany Abrams, Senior Manager, International Quality, Strategic Sourcing, EDWARDS LIFESCIENCES
5:00 CLOSING REMARKS & DAY 1 CONCLUSION
6:30 CONTINUED NETWORKING: FACILITATED GROUP DINNERS
* With the immense value in peer-to-peer interaction and experience sharing, we wish to provide attendees with an opportunity to continue networking after the first day of the conference. Q1 Productions will arrange dinner reservations at local restaurants close to the conference hotel for those interested in joining a group of fellow participants for dinner on February 28th. Please note that dinner expenses must be covered by each participant individually.