9th Annual Medical Device Supplier Quality Assurance Conference

April 29-30, 2019 | Arlington, VA
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“I thought the conference was excellent!  Having a conference tailored to one discipline made each panel and contact relevant.”

Director, Compliance & Legal Affairs
Orexigen

“Great insight to hear payer perspective in contracting and account management and the changing healthcare landscape.”

Channel Liaison
Biogen

“It was definitely an excellent well-rounded opportunity to meet new people, get new ideas, and get an in-depth education on what’s to come with the FDA collaborations.”

Quality Engineer
Centurion Medical Products

“It was very well organized event and high quality, the fact to have an IVD track was also interesting. Thanks, I will recommend the Q1 event!”

Regulatory Affairs – EMEA Regional Head
BIOMERIEUX

“The organization and support staff were fantastic! I’m looking forward to next year.”

Global Business Project Lead
Genentech

About the Conference:

Supplier Quality Assurance executives face a wide array of challenges in the qualification, validation and monitoring of supplier partners who provide critical components, medicinal mechanisms as well as software being integrated into medical products. Of primary importance throughout the management of suppliers is the definition of risks with each partner, identifying all potential risks and weighting each to ensure monitoring processes are handled appropriately. In addition, executives must consider the impact of MDSAP and ISO 13486:2016 audits on suppliers, ensuring a readiness for more process oriented audit experiences.

Topics to Be Addressed:

  • Multiple Perspectives on MDSAP: FDA, NB, Industry
  • Alignment of ISO 13486 with MDSAP processes
  • Supplier re-evaluation in light of ISO 13485:2016
  • Impact of EU MDR on Supplier Quality Validation
  • Supplier Qualification: Critical vs. Non-Critical Suppliers
  • Bridging the Gap Between Supplier QA & Procurement

Program Highlights:

  • Direct Regulatory Interpretation from FDA & Notified Bodies
  • Global-Centric Content Focused on Holistic Supplier QA
  • Procurement & Sourcing Perspectives to Balance Quality
  • Heavy Industry Participation for Wide Ranging Perspectives

Audience

75 Attendees

All attendees come directly from medical device companies

Distinguished Presenters

Speaker recruitment in process

Networking

Networking time is built into the agenda to allow industry peers to connect and exchange ideas

Open Dialogue and Group Share

Each presentation is followed by 10-15 minutes of open dialogue for questions and exchange of best practices

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