8TH SEMI-ANNUAL RISK BASED MEDICAL DEVICE SUPPLIER QUALITY ASSURANCE CONFERENCE

JUNE 11-12, 2018 | MINNEAPOLIS, MN

MILLENNIUM MINNEAPOLIS HOTEL

Download AgendaRegister Now

DAY ONE | MONDAY, JUNE 11

8:00 REGISTRATION AND WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS

9:00 KEYNOTE: UPDATE ON CURRENT FDA INITIATIVES RELATING TO SUPPLIER QUALITY EXPECTATIONS
Supplier quality executives must not only focus on staying at the forefront of industry led initiatives to ensure product quality, but also continue to remain compliant on all FDA regulations and requirements. As such, understanding FDA initiatives relating to evolving expectations for supplier quality along with potential external factors impacting FDA’s inner workings is paramount for supplier quality teams. Branch Chief of Cardiovascular Device, Daniel Walter, will present on current and upcoming FDA initiatives relating to supplier quality, showcasing to the industry crucial information for ongoing compliance.

Daniel Walter, Branch Chief for Cardiovascular Device, FDA

 

9:30 FIRESIDE CHAT WITH FDA
At the center of all supplier quality practices is the need to remain compliant with FDA requirements, ensuring the comprehensive safety and effectiveness of medical devices. As such, hearing directly from the agency on supplier quality expectations plays a crucial role in ongoing compliance within a medical device company. This dialogue between FDA Branch Chief of Cardiovascular Device, Daniel Walter, and industry expert with over 30 years of experience at the FDA, Steve Niedelman, will focus on industry perspectives surrounding supplier quality through addressing pre-submitted questions from the audience on the following topics:

  • FDA inspections trends
  • Impact of ISO 13485
  • Process validation

Daniel Walter, Branch Chief for Cardiovascular Device, FDA

MODERATED BY:
Steve Niedelman, Lead Quality System and Compliance Consultant & Former Deputy Associate Commission of Regulatory Affairs at FDA
KING & SPALDING

 

10:00 COFFEE & NETWORKING BREAK

 

10:30 STEPS REQUIRED TO DOCUMENT SUPPLIER RISK ASSESSMENT IN ALIGNMENT WITH ISO 13485:2016
One of the biggest additions to the 2016 revisions to ISO 13485 is the requirement for manufacturers to prove to notified bodies and regulatory agencies that suppliers have been thoroughly evaluated for risk. Without an industry standard QMS, manufacturers are made responsible for creating a system that along the way collects the necessary evidence to prove correct and detailed supplier risk evaluation during audits. A notified body will give a comprehensive roadmap starting with necessary steps to evaluate suppliers and a clear definition of risk from an auditing perspective to best practices for preparation of all essential evidence to prove suppliers have been evaluated correctly, equipping executives with knowledge to create an internal system documenting supplier quality from initial stages to audit.

  • Documentation supporting supplier risk assessment
  • Best systematic practices to assess supplier risk
  • Communicating effective demonstration of quality to suppliers

Dennis Gucciardo, Senior Associate, HOGAN LOVELLS

 

11:15 MULTI PART MODULE: IMPACT OF THE MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP) ON SUPPLIER AUDITS, OVERSIGHT & MONITORING
Following the successful pilot program from 2014 through 2017, the International Medical Device Regulators Forum (IMDRF) along with agency partners including the US FDA, have confirmed the viability and continuation of the Medical Device Single Audit Program (MDSAP), which will continue to replace routine Agency inspections on an international scale for both medical device manufacturers as well as supplier partners. Through streamlining audit processes and enabling a single audit of a supplier to meet regulatory requirements of multiple Agencies on a global scale, suppliers and manufacturers are able to recognize cost and time-savings as compared with conducting several audits covering the same material. As the program continues, manufacturers look to the FDA for reports on current findings, as well as industry experiences in both audit conduct as well as summary conclusions of supplier audits.

MODULE ONE: CERTIFIER PERSPECTIVE ON MDSAP

  • Brief introduction to supplier audits via MDSAP
  • Clarification into repeat findings in supplier audits
  • Supplier audit findings & enforcement trends

Zina Apostolou-Keiper, Business Field Manager – Medical Audit
TUV RHEINLAND OF NORTH AMERICA, INC.

 

12:00 LUNCHEON FOR ATTENDEES, SPEAKERS, & SPONSORS

 

1:00 MODULE TWO: BREAKOUT DISCUSSIONS BENEFIT ANALYSIS

  • Communicating MDSAP process to suppliers
  • Alignment of supplier documents with audit format
  • Preparing global suppliers for MDSAP analysis
  • Cost-benefit analysis of supplier MDSAP participation

 

1:30 NOTIFIED BODY PERSPECTIVE: IMPACT OF EU MDR ON MEDICAL DEVICE SUPPLIER QUALITY OPERATIONS
The new European Medical Device Regulation (MDR) released in mid-2017 creates a modern framework for manufacturer and distributor compliance across the European territory, with changes to existing directives having a wide and comprehensive impact on current operating procedures. Supplier quality executives find concern surrounding the correct and appropriate interpretation of regulations as related to supply chain, distribution and enhanced traceability requirements, which take a granular approach to product component tracking. With compliance deadlines rapidly approaching, medical device firms must consider how to effectively integrate critical suppliers into internal quality systems, as well as securing secondary suppliers of critical components as a risk-mitigation factor.

Zina Apostolou-Keiper, Business Field Manager – Medical Audit
TUV RHEINLAND OF NORTH AMERICA, INC.

 

2:15 COFFEE & NETWORKING BREAK

 

2:45 CASE STUDY: RISK-BASED APPROACH TO GLOBAL SUPPLIER QUALIFICATION & MANAGEMENT
As medical device corporations increasingly look to secure components and materials at reduced costs but of the highest quality possible, supplier bases have expanded to a global level, with supplier partners manufacturing products around the world for inclusion in finished medical products sold in the US and beyond. While regulatory guidance surrounding manufacturing processes is often linked to local frameworks and ISO guidance, supplier quality assurance executives must ensure that suppliers and sub-tier suppliers are following requirements linked to additional regulators, including the US FDA. Additionally, strategic approaches to operational management of a global supplier base require in-depth knowledge and tactical monitoring to mitigate risks and ensure quality procedures are being adhered to.

  • Development of a global supplier quality agreement
  • Development of a global supplier and purchased product qualification
  • Managing suppliers to meet global regulatory requirements

Paul Hakamaki, Vice President of Quality, DOVER CORPORATION
Fast Fact: Paul also brings 28 years of supplier quality experience in the medical device industry

 

3:45 FIRESIDE CHAT: NASA’S PERSPECTIVE ON SUPPLIER QUALITY EXCELLENCE
The automotive and aerospace industries have long demonstrated excellence in supplier quality assurance, including supplier development, oversight, validation, and risk mitigation, through the implementation of a standardized process. Medical device executives value external perspectives for direction in methods to create a system that ensures the highest caliber of supplier quality. Although there are many differences between the automotive and aerospace industry and the medical device industry, parallels will be drawn that allow supplier quality executives to gain insight into well established and practiced processes on an industry level and applicable solutions on an internal level.

  • Beneficial documentation of supplier quality management
  • Best practices for working with supplier and sub-tier suppliers
  • Communicating quality expectations throughout the supply chain

MODERATOR:
Robert Steele, CONVATEC

AEROSPACE PERSPECTIVE:
Steve Foster, NASA

 

4:30 FIRESIDE CHAT: UTILIZATION OF THIRD PARTY SUPPLIER QUALITY PROGRAMS AND ACCREDITATION ORGANIZATIONS
Many executives look to third party programs and organizations to provide monitoring and auditing of suppliers and sub-tiered suppliers to demonstrate a high level of dedication to quality assurance. With many proposed benefits, such as identifying areas of improvement through audits, supplier quality certification programs are giving participating OEMs an advantage in the global marketplace as more of the industry engages with accreditation organizations and requires certification for suppliers. Executives will examine a real life example from a participating OEM and supplier to gain insight to the actionable steps and benefits of working with a third party supplier quality program.

  • Financial and systematic benefits of accreditation
  • Communicating accreditation requirements to suppliers
  • Accreditation roll out on a global scale

MODERATED BY: Connie Conboy, PERFORMANCE REVIEW INSTITUTE

PANELISTS:
Ann Sheldon, MEDTRONIC

Scott Goolsbey, STRYKER

 

5:15 DAY ONE CONFERENCE CONCLUSION