What You Will Learn

At the conclusion of this workshop, you will be able to:

• Identify requirements for supplier quality management, including ISO 13485:2016, US FDA, MDSAP, and the EU MDR.
• Establish a risk-based process for evaluating, selecting, and reevaluating your suppliers.
• Translate needs into purchased product and supplier requirements.
• Develop and maintain an Approved Supplier List and manage your outsourced processes.
• Understand the elements of a good quality agreement and when they are needed.
• Implement an effective process for verifying purchased product and monitoring ongoing supplier performance.
• Manage supplier nonconformances, escalation of issues, and supplier change notification.
• Create clear product specifications and head off potential issues before they occur.
• Identify and resolve supplier issues before they escalate.

Who Should Attend

Anyone involved in sourcing, securing, and maintaining critical suppliers and services that affect product quality and organizational reputation. Attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485.