The supply chain is often the weakest and most vulnerable link in a company's quality system. Supplier controls remains at the top of CDRH concerns and enforcement priorities. For manufacturers, supplier issues affect product quality and the corporate bottom line.
 
Key challenges are developing and applying a risk-based approach to supplier selection and management, and procedures for auditing and scoring supplier performance and making best use of collected data.
 
In this web event, experts present results of a survey on the top industry concerns, best practices in risk management and appropriate oversight of suppliers. A speaker from a major consumer electronics company offers a comparative perspective from an industry noted for excellence in supply chain management.
 
Who should attend:
Quality and Regulatory Affairs professionals, Supply Chain managers, Purchasing, and others involved in vendor selection and auditing from medical device companies. Also, senior management, quality, regulatory, business development personnel from suppliers to the medical device industry.
 
Agenda:
 
Global Sourcing and Contract Manufacturing
Daniel Matlis - Principal, Axendia

• Results of a recent survey of senior industry executives identifying concerns about foreign-sourced raw materials and contract manufacturing
• Strategies for reducing and controlling risks while taking advantage of outsourcing cost benefits

Risk Management and Supplier Controls
Joel Roth - Senior Manager, Regulatory Compliance, Edwards Lifesciences

• Establishing risk criticality levels for outsourced products and services
• A risk-based approach to supplier assessment and auditing

Maintaining and Monitoring Supplier Quality
Steve C de Baca - Vice President of Quality, Boston Scientific

• Auditing and scoring supplier performance
• Identifying the data you need and the form in which to store it
• Advantages and pitfalls of data automation
• Using audit data for continuous improvement

Benchmarking with a Leader in Consumer Electronics
Michael Shepherd, Technologist, Dell

• Comparing and contrasting practices in the medical technology industry with those in a field known for excellent supplier controls

Panel Discussion
 
Complimentary Registration is made possible by our sponsors: Camstar and Pilgrim Software
 
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