Supplier Management for Medical Device Manufacturers 2017

Topics

• The FDAs multi-tier supplier classification system
• FDA QSR and ISO 13485 requirements for supplier management
• An 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
• Receiving inspection criteria and apply them as part of supplier controls
• How to develop and implement supplier controls
• System for supplier business risk
• Supplier measurement and monitoring systems
• Risk based system for supplier audits
• System for supplier regulatory risk
• Supplier audit using the backward trace process approach

Who should Attend

• 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