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Handling Medical Device Complaints and CAPA

This course strengthens the ability to evaluate complaints, determine appropriate CAPA actions, and manage post-closing effectiveness activities with greater consistency. It supports stronger inspection readiness by improving decision-making across investigations, risk evaluation, and corrective action documentation. This Course is designed for professionals responsible for medical device quality processes, complaint evaluation, investigation, and corrective actions.

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US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Edwin Waldbusser
  • Study time : 60 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3398
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Complaint handling and Corrective and Preventative Action (CAPA) activities directly affect medical device safety, product quality, and regulatory compliance. FDA inspections frequently identify weaknesses in complaint evaluation, CAPA investigations, corrective action planning, and effectiveness verification, making these processes a critical operational focus for medical device organizations. Consistent handling of complaints and nonconformities requires clear decision pathways supported by risk analysis, documented investigations, and measurable follow-up activities.


This course addresses the full complaint handling and CAPA lifecycle, from information gathering through MDR and recall decision-making, investigation reporting, corrective action planning, verification, validation, and post-closing effectiveness evaluation. Additional attention is given to preventative action activities that are often underused, including proactive information gathering and post-distribution monitoring methods such as customer surveys. The course also examines how manufacturing non-conformities should integrate with the CAPA program while maintaining practical control over the number and scope of CAPAs initiated.

  • Strengthen Complaint Evaluation and CAPA Decisions:

    Participants will improve their ability to distinguish between routine product issues, reportable complaints, and situations requiring formal CAPA investigation. The course clarifies how risk analysis, investigation findings, and product information should guide MDR, recall, and corrective action decisions while supporting consistent documentation practices that withstand regulatory scrutiny during inspections.

  • Improve CAPA Effectiveness and Program Oversight:

    The course provides practical direction for managing CAPA activities beyond initial corrective actions, including verification, validation, and post-closing effectiveness checks. Participants will also gain better control of CAPA program metrics, preventative action activities, and integration of manufacturing non-conformities, helping reduce recurring quality issues and unsupported CAPA escalation across operations.

Key Areas Covered

  • Complaint sources, information gathering activities, and proactive post-distribution monitoring methods
  • Evaluation criteria for determining complaints, investigation requirements, and CAPA initiation decisions
  • Risk analysis methods applied to complaint handling and CAPA assessment activities
  • Root cause determination and preparation of CAPA Investigation Reports with Corrective Action Plans
  • Verification and validation activities supporting CAPA implementation and effectiveness evaluation
  • MDR and recall decision-making processes associated with complaint and CAPA management
  • Integration of manufacturing non-conformities within the CAPA program structure
  • CAPA program metrics and post-closing effectiveness monitoring for ongoing quality oversight

Who Must Attend

  • QA/QC Personnel
  • Medical Device Engineering
  • Software Developers
  • Regulatory Affairs Departments
  • Design Engineering Managers
  • Production Management

Quality training, expert insights, and answers that matter. Know your Expert

EDWIN WALDBUSSER

Edwin Waldbusser retired from industry after 30 years managing medical device product development and company quality systems. His experience includes CAPA, risk analysis, design control, software validation, supplier qualification, and non-conforming product programs across IVD devices, dialysis systems, and inhalation devices. He currently consults on medical device quality systems with emphasis on design control, software validation, risk analysis, and human factors analysis. He is also certified by Lloyds of London as an ISO 9000 Lead Auditor.

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Our students love us ❤️

“Slides were clear. No clutter. That made it easier to stay focused.”


QA Personnel

“Content was relevant. Not outdated examples. That matters.”

Manager, Medical Device Engineering

“Would consider similar sessions again. Format worked for us.”


Director, Regulatory Affairs

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