Back to Basics: CAPA

Build a CAPA system that regulators trust—and teams can execute with consistency.

Practical, regulator-aligned guidance for designing, maintaining, and executing an effective CAPA process under ISO 13485:2016 and the FDA QMSR—with a closed-loop approach that stands up to audits and inspections.

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What You’ll Gain

By the end of this course, you will be able to:

  • Understand CAPA expectations under ISO 13485:2016 and FDA QMSR

  • Apply risk-based decision making to CAPA initiation and routing

  • Use data analysis and investigation tools to identify defensible root causes

  • Build clear, cross-functional action plans with documented approvals

  • Verify effectiveness and document sustained outcomes that hold up in audit/inspection

What’s Included

  • Five self-paced video lessons covering CAPA as a closed-loop system, risk-based initiation, investigations, action planning, and effectiveness checks.

  • A knowledge assessment to confirm comprehension.

  • A completion certificate for training documentation.

  • 12 months access to all lessons and downloads.

Who This Course Is For

  • On-Demand Video Lessons – Expert-led training covering QMSR structure, design controls, supplier management, CAPA, and compliance strategies.
  • Templates and Cheatsheets – Essential regulatory documents, including audit checklists, CAPA templates, and QMS roadmaps.
  • Downloadable Resources – Practical guides on QMSR requirements, FDA inspection preparation, and ISO 13485 alignment.

This course is designed for:

  • Operations leaders who need CAPA to drive sustained control
  • CAPA owners, investigators, and approvers who must document decisions clearly
  • Teams preparing for ISO audits, FDA inspections, or internal remediation
  • Quality and Regulatory leaders responsible for CAPA system performance 
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