Purchasing Controls and Receiving Acceptance for Medical Devices
  • CODE : SUMA-0011
  • Duration : 90 Minutes
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Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with an emphasis on quality, compliance, and Six Sigma. She has worked at industry-leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices including roles as Worldwide Director of Design Quality, Worldwide Director of Product Quality, Executive Business Consultant, and Director of Corporate Compliance. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications in Six Sigma while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification from RAPS and Quality Auditor Certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.

This webinar 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 webinar 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.

Areas Covered

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
    • Authority and Scope
    • A balance between Supplier Control and Receiving Acceptance
  • Purchasing Controls Process
    • Planning
    • Evaluation of Suppliers
    • Purchasing Data
    • Performance Management
    • Feedback and Communication
  • Best Practices

Course Level - Intermediate

Who Should Attend

Medical Device Companies

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

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.

  • $200.00



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