Medical Device Supplier Qualification and Management

Medical Device Supplier Qualification and Management - Practical Approaches to Cost Effective Implementation
Regulators around the globe are looking more closely at supplier management issues as device manufacturers extend their processes down the supply chain and acquire components across national boundaries. Are you ready for the increased scrutiny from FDA Investigators and Notified Bodies?
You can start to prepare with important GHTF guidance documents: Control of Suppliers (GHTF/SG3/N17:2008), Risk Management Principles in a QMS (GHTF/SG3/N15R8), and Corrective Action & Preventive Action in a QMS (GHTF/SG3/N18:2010). These guidance documents provide the foundation, but lack practical details. This workshop gives you the tools and methods you need for a cost effective implementation.
Attendees will learn:
• The shape of the industry and current trends
• The overall process and the major steps involved
• Principles of risk management applied to supplier qualification and controls
• The role of basic and advanced questionnaires to get the information you need
• How to conduct an on-site supplier audit applying risk management
• The issues presented by virtual suppliers
• How to select and apply supplier metrics and their role in the QMS management review
• Producing records and issues with their retention
BONUS: Attendees will receive copies of implementation tools, including a process map, sample questionnaire, reevaluation form, audit checklist and more.
Dan O'Leary, President, Ombu Enterprises
John Avellanet, Principal Consultant, Cerulean Associates (Co-chair)