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