Supplier Management for Medical Device Manufacturers 2016

Topics

• FDA`s multitier supplier classification system
• Understand FDA QSR, ISO 13485:2003, and ISO 13485:2016 requirements for supplier management
• Analysis matrix and radar chart to compare suppliers
• When suppliers have to register and list with the FDA
• An overall supplier management plan
• The link between design control and purchasing data
• Create receiving inspection criteria and use them as part of supplier controls
• How to develop and implement supplier controls
• The three application of risk management: business risk, regulatory risk, and medical device risk
• Develop supplier measurement and monitoring systems
• Developing a supplier audit using the backward trace process approach
• How to determine when to audit a supplier and the audit`s scope

Who should Attend

Attendees from:

• Supply Chain Managers
• Quality Managers
• Supplier Quality Engineers
• Quality Engineers
• Regulatory Specialists
• Purchasing Professionals
• Design and Development Engineers
• Production and Process Engineers
• Verification and Validation Specialists