Purchasing Control Essentials for Medical Devices

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

Why Should You Attend:

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.

Areas Covered in the Webinar:

This 90-minute webinar will focus on establishing an effective and efficient system of purchasing controls. Topics to be covered include:

• Understanding the regulations
• Lessons Learned
• FDA Expectations
• Purchasing Controls Process
• Planning
• Evaluation of Suppliers
• Purchasing Data
• Performance Management
• Feedback and Communication
• Balance between purchasing control and receiving inspection
• Best Practices
• Inspection Readiness

Who Will Benefit:

• Supplier Engineers
• Supplier Auditors
• Internal Auditors
• Supplier/Purchasing Managers
• Quality Engineers
• Supplier Quality Engineers
• Compliance Personnel
• Compliance Specialists