Supplier Management for Medical Device Manufacturers 2016

Key Topics

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

Who should Attend

Attendees from:

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