Purchasing Controls - Enabling You to Provide Safe and Effective Products

Susanne Manz

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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. Additionally, finished Device Manufacturers have had to deal with significant quality issues including recalls because of purchased materials and components. 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!

Course Objective

  • Understand FDA Expectations for Purchasing Controls
  • Understand lessons learned from recalls and other major quality issues
  • Steps to developing effective purchasing controls
  • How the FDA will determine cracks in your process
  • How to manage your suppliers
  • Learn what documents the FDA will want to see

Course Outline

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

  • Lessons Learned
  • FDA Expectations
  • Authority and Scope
  • Purchasing Controls Process
  • Planning
  • Evaluation of Suppliers
  • Purchasing Data
  • Performance Management
  • Feedback and Communication
  • Best Practices

Target Audience

  • Individuals new to Medical Device Companies
  • Supplier Quality Engineers
  • Supplier Managers/ Purchasing Managers
  • Compliance Personnel
  • Auditors
  • Managers and Individuals in Purchasing / Supplier Management

Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Susanne Manz,

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) 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.

Get in touch

(315) 632-0735,
(315) 750-4379