Supplier Quality Agreements for Medical Devices

Why Should You Attend:

Effective supplier management can help prevent problems and reduce their impact should they occur. With the increased emphasis on supplier management, you can expect strong coverage of this area during an FDA Inspection. The FDA's Quality System Regulation (QSR) explains how a device manufacturer must manage suppliers. This ranges from supplier evaluation and selection to control methods. One common approach uses a supplier quality agreement.

This 90-minute training will help you understand the FDA QSR requirements, good business practices, and the role of a supplier quality agreement. This webinar will help you set up an effective and FDA compliant supplier management system.

Areas Covered in this Webinar:

• FDA QSR Requirements for Purchasing
• The Supplier Quality Agreement
• Administrative Elements
• Compliance
• Manufacturing, Packaging, and Labeling
• Documentation and Records
• Storage and Shipment
• Change Control
• Non-Conformance, CAPA, and Complaints
• Auditing

Who will benefit:

This webinar provides valuable information for those involved in supplier management in the medical device industry.

People in the following roles can especially benefit from the knowledge in this webinar:

• Medical Device Quality Managers
• Regulatory Affairs Managers at medical device companies
• Risk Managers
• Medical Device Supply Chain Managers
• Purchasing Professionals
• Medical Device Supplier Management Team

Instructor Profile:

Dan O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and holds an APICS certification in Resource Management.

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