Supplier Management for Medical Device Manufacturers 2019

Key Topics

• Creating a Risk-based Multi-tier supplier classification system
• Understand FDA QSR and ISO 13485 requirements for supplier management
• Defining and using supplier Metrics
• Understand when suppliers have to register and list with the FDA
• Develop an risk-based supplier management process
• Explain the link between design control and purchasing data
• Understand the how to develop and implement supplier controls
• Create supplier measurement and monitoring systems
• How to prepare yourself and your contract manufacturer for unannounced audits from your Notified body
• Create a risk based Value-added system for supplier audits
• Creating acceptance criteria and understand how that fits into your supplier control process

Who should Attend

• Quality Engineers
• Quality Managers
• Supplier Engineers
• Audit Managers
• Supplier auditors
• Internal quality auditors
• Quality Specialists
• Quality associates
• Regulatory Compliance Managers