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Purchasing Controls, Supplier Management, and Receiving Acceptance for Medical Devices (August 19-20, 2021)

  • ID: 5378995
  • Training
  • August 2021
  • Region: Global
  • 2 Days
  • Compliance Online
  • Training Dates: August 19-20, 2021

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
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Day 01 (9:00 AM - 3:30 PM EDT)

09.00 AM: Session Start

  • Understanding the regulations
  • FDA QSR and ISO13485
    • GHTF guidance
    • FDA Expectations
    • Authority and Scope
    • Balance between Supplier Control and Receiving Acceptance
    • Purchasing Controls Process
    • Purchasing Data
  • Planning Purchasing Control and Supplier Management
    • Supplier Management business process
    • Business risk
    • Regulatory risk
    • Medical Risk
  • Planning for Supplier Selection
    • What is being purchased
    • Design Control and purchasing data
    • Identify Risks (business, regulatory, medical)
    • Identify Controls (business, regulatory, medical)
  • Evaluation of Potential Suppliers
    • Identify potential suppliers
    • Evaluate business capability
    • Evaluate operational capability
    • Evaluate quality capability

Day 02 (9:00 AM - 3:30 PM EDT)

  • Supplier Selection
    • Sole vs Single source
    • Selecting the supplier
    • Maintaining an ASL (Approved Supplier List)
  • Implementing Supplier Controls
    • Control Plan
    • Receiving Inspection
    • Risk-based audits
    • Purchasing Data
    • Quality Agreements
  • Performance Management
    • Supplier scorecards
    • Standard metrics
    • Supplier Reviews
    • Maturity Models
  • Feedback and Communication
    • Supplier Reviews
    • Supplier Corrective Action Requests (SCARs)
  • Lessons Learned
  • Supplier Audits
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  • Susanne Manz Susanne Manz,
    President and Principal Consultant ,
    Manz Consulting, Inc.

    Susanne Manz 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.

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  • Quality Managers
  • Supplier Engineers
  • Supplier/Purchasing Managers
  • Quality Engineers
  • Supplier Quality Engineers
  • Compliance Personnel
  • Supplier Auditors
  • Compliance Specialists
  • Product and Process Engineers
  • Design Engineers
Note: Product cover images may vary from those shown