Learning Objectives:

• Understand the FDA’s requirements for medical device supplier assessment and approvals.
• “Who” are considered to be suppliers?
• How to structure a Supplier Quality Agreement
• What are the potential methods for evaluating and assessing suppliers?

Areas Covered in the Session:

• Supplier Quality Management Overview
• Supplier Selection, Approval, and Disapproval
• Supplier Evaluation and Performance Monitoring
• Supplier Approval Status: Approved, Conditional, Disapproved, Probationary
• Supplier Change Control
• Supplier-Related Corrective and Preventive Action, Continuous Improvement, and Development
• Supplier Quality Agreements
• Supplier Contract and Agreement Administration
• Supplier Records

Who Will Benefit:

• Quality Assurance/Quality Control Directors, Managers, and Specialists
• Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
• Purchasing/Materials Management Directors, Managers, and Specialists
• Engineering/Development Directors, Managers, and Specialists
• Document Control Managers and Specialists