Supplier Quality Management: Implement it Now or Pay for it Later

This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.

This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.

Why Should You Attend:

Failure to adequately assess and control your supplier/subcontractor pool can result in dire consequences for an organization. Aside from the regulatory implications for failure to comply with FDA’s requirements, not assessing and monitoring your suppliers can result in product recalls, high levels of complaints, potential patient/user injuries and deaths, and expensive lawsuits. Not explicitly defining the responsibilities of your suppliers can lead to adulterated and mis-branded product, as well as unnecessary costs associated with cost of good and overhead.

Assessing and approving your suppliers before placing the first order with them will eliminate many headaches for a medical device manufacturer.

This webinar will provide attendees with the information and tools necessary to develop, implement, and effectively utilize and maintain a program for Supplier Quality Management that will satisfy the FDA’s requirements without creating undue burdens for the organization.

Areas Covered in the webinar:

• 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

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?

Who Will Benefit:

This webinar will provide valuable assistance to the following departments of medical device manufacturers:

• 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
• Medical Device Suppliers
• Medical Device Contractors, OEMs