Risk-based Supplier Management System: ImpactImpact on Regulatory and Operational Goals for Medical Device Manufacturers 2015

Key Topics

• Learn about the two guidelines that cover current FDA and ISO 13485 expectations for supplier control
• Understand the types of suppliers that must be qualified according to the FDA and ISO 13485
• Understand how to create or bring your supplier program into compliance with the these guidance documents while optimizing the resources needed to comply
• Understand how to use the Global harmonization Task Forces (GHTF) and NBOC supplier guidance documents that you could be audited to
• Understand how to define and control supplier risk and why this benefits your company
• Understand requirements for Critical suppliers
• Learn about best practices for supplier qualification and control

Who should Attend

Attendees from:

• Regulatory Affairs
• Quality Management
• Supplier Engineering
• Supply-Chain Management
• Supplier Auditing
• Purchasing Management
• Quality Engineering
• Internal Auditing