Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls. Purchasing Controls continue to be a leading source of 483 and Warning Letter citations. This course will examine real-life warning letters to deepen your understanding of important concepts

Learning Objectives:

• Understand QSR 820.50, 820.80, and ISO13485:2016
• Understand GHTF guidance
• FDA QSIT approach to inspection
• FDA authority over medical device manufacturers and their suppliers
• Develop a risk-based approach to supplier audits

Who will Benefit:

• Quality Managers
• Supplier Engineers
• Supplier/Purchasing Managers
• Quality Engineers
• Supplier Quality Engineers
• Compliance Personnel
• Supplier Auditors
• Compliance Specialists
• Product and Process Engineers
• Design Engineers