Product Details
Medical Device Purchasing Controls: Building Compliant Systems
FDA investigators are keeping a sharp eye on your supplier management program. How can you remain in compliance?
Industry expert Dan helps you understand expectations using the regulations, their explanation in the QSR preamble, the GHTF guidance, and warning letters that illustrate the issues.
After listening to this 90-minute session you will be able to:
- Describe the elements of supplier evaluation and selection
- Develop “purchasing data” to define the component, service, and supplier requirements
- Maintain supplier records to demonstrate the systems effectiveness
- Establish procedures to accept or reject incoming product or services
- Explain the additional requirements in ISO 13485:2016
BONUS MATERIALS: Attendees will receive a QSR checklist for supplier selection and control and a comparative analysis in QSR, ISO 13485:2003 and ISO 13485:2016 requirements.
Order today and begin creating an integrated, efficient and compliant supplier management system.