Training: Corrective & Preventive Actions (CAPA) Training
Build practical understanding of CAPA requirements, root cause investigation, corrective action planning, and effectiveness checks within medical device quality systems.
Training Overview
CAPA is the backbone of an effective quality management system.
When CAPA processes fall short, especially in root cause investigation and verification of effectiveness, organizations face some of the most common serious audit and inspection findings.
This training helps participants understand the requirements behind an effective CAPA subsystem and apply practical methods for CAPA implementation. Participants will review regulatory expectations, CAPA terminology, quality system linkages, data sources, process sequencing, root cause analysis techniques, and corrective action planning. The course also includes a CAPA case study to help participants apply the process in context.
- Date: October 6, 2026
- Time: 9:00 AM to 4:40 PM CET
- Price:
Member price: 5,630 DKK ex. VAT
Non-member price: 8,660 DKK ex. VAT
Valentina Lintas
Quality and Regulatory Affairs Manager
Valentina is a biomedical engineer with over seven years of experience in the medical device industry, specializing in regulatory and quality affairs. She holds a strong academic and research background in tissue engineering and minimally invasive cardiovascular technologies, which she has successfully translated into regulatory expertise across diverse MedTech domains. At Veranex, Valentina contributes to a wide range of regulatory and quality activities, including the drafting and critical review of technical documentation, development of regulatory strategies for EU, CH, and US markets, execution of QMS audits, and tailored support for quality system implementation and compliance with European medical device regulations.
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Training Objectives
Participants will learn how to:
- Understand the regulatory requirements behind CAPA procedures
- Use the correct terminology and wording around CAPA
- Explain logical links within a quality system, including 21 CFR 820 and ISO 13485
- Connect CAPA to post-market surveillance, risk management, vigilance, and design change control
- Identify data sources that can trigger CAPA activity
- Understand CAPA process sequencing and documentation expectations
- Apply root cause investigation techniques
- Determine effective corrective actions tied to identified root causes
- Plan methods and timelines to verify CAPA effectiveness
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Training Content
- Requirements from 21 CFR 820 and ISO 13485 for corrective and preventive action
- CAPA definitions and terminology
- Internal and external CAPA data sources
- Logical CAPA sequences to follow and document
- Root cause determination tools and methods
- Planning activities, competence needs, and effectiveness checks
- CAPA case study exercise focused on sequencing and root cause analysis
- Discussion of case study results
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Training Format
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Online format with:
- Presentations with interactive discussions
- Group and individual exercises
- End-of-training assessment
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Prerequisite
None
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Target Audience
- Management staff
- Engineers working in development
- Quality Assurance managers or individual contributors
- Quality Assurance Staff
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Price
Member: 5,630 DKK ex. VAT (~$881 USD ex. VAT)
Non-member: 8,660 DKK ex. VAT (~$1,355 USD ex. VAT)
Learn from Specialists Who Work Inside Medtech Complexity Every Day
Talk with Veranex about upcoming training dates, private sessions, or tailored programs built around your organization’s device, IVD, regulatory, clinical, or quality needs.