Purchasing Controls, Supplier Management, and Receiving Acceptance for Medical Devices

This 2-day virtual seminar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls! This virtual seminar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control. You’ll learn about the essential elements of purchasing control and how you can translate them into your procedures. We’ll discuss the process steps for purchasing control and how it relates to other parts of your QMS including receiving and acceptance activities.

Inadequate supplier/purchasing control can lead to a multitude of problems including rejections or delays at receiving inspection; non-conformances and scrap on your manufacturing lines; and quality problems that can manifest later in the field resulting in MDRs and recalls.

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