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Combination Product Device Supplier Management Training

What You Will Learn

At the end of this workshop, you will be able to:

• Identify regulatory requirements and international standards for supplier quality management applicable to combination products, including ISO 13485:2016, US FDA, ICH, and the EU Medical Device Regulation
• Describe the life cycle of supplier quality management
• Describe the role of supplier management in the design development process of a combination product
• Describe the role of quality agreements in managing outsourced processes
• Explain the importance of supplier audits and their role in supplier management
• Establish a risk-based process for evaluating, selecting, and reevaluating suppliers
• Translate product development and manufacturing needs into purchased product and supplier requirements
• Develop and maintain an approved supplier list
• Develop an effective supplier quality monitoring and measurement process
• Communicate supplier quality management system status to the management team
• Plan and implement an effective process for verifying purchased product
• Manage supplier nonconformances and escalation of issues through the supplier quality management and related quality management system processes

Who Should Attend

Personnel involved in sourcing, securing, and maintaining suppliers for combination products that ensure excellent product quality and organizational reputation, including supplier quality and procurement/supply chain managers; product development engineering managers; management representatives; product, project, and program managers; RA/QA managers/engineers; auditors; and other crossfunctional team members.