Suites 198 E Delaware Pl
Chicago , IL 60611 Location map
Managing Suppliers in the Medical Device Industry
Device manufacturers face issues and confusion when setting up and maintaining a supplier management program. Some of this confusion results from the regulations. While they contain requirements, the details are dependent on the device manufacturer’s ability to create an effective and efficient system.
This workshop will help the device manufacturer through a unique format of explanation, discussion, and practical application. The course is built of modules based on the Global Harmonization Task Force (GHTF) guidance document on the control of products and services obtained from suppliers. It describes the necessary controls in a model that includes six phases:
- Selection potential suppliers
- Supplier evaluation and acceptance
- Establishing controls
- Delivery, measurement, and monitoring
- Feedback and communication, including Corrective Action and Preventive Action processes
The course follows these phases and explains the regulatory requirements in the Quality System Regulation (QSR), ISO 13485:2003, the Medical Device Directive (MDD), EN ISO 13485:2012, and other requirements.
Contact the event managers listed below for more information about how you can participate at the Managing Suppliers in the Medical Device Industry.
Supply Chain Managers
Supplier Quality Engineers
Production and Process Engineers
Design and Development Engineers
Verification and Validation Specialists
Upon course completion, participants will:
Understand FDA QSR and ISO 13485:2003 requirements for supplier management
Understand the FDA's multi-tier supplier classification system
Understand when suppliers have to register and list with the FDA
Use an analysis matrix and radar chart to compare suppliers
and so on
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