CAPAFounding list open

Root Cause and CAPA Essentials

Turn investigations into corrective and preventive actions that address the cause and can be shown to have worked.

Duration: 3 hours, self-paced
Level: Practitioner
Lessons: 6 lessons

Do I really need this course? See a sample lesson

What the course teaches and assesses

Decide when an investigation needs a CAPA and when it does not
Select a root cause tool that fits the evidence you actually have
Treat human error as a symptom and name the contributing system factor
Write corrective and preventive actions that someone else can verify
Design an effectiveness check with a criterion, a date and data behind it

Lessons

1When an investigation needs a CAPA, and when it does not
2Root cause tools: 5 Whys, Ishikawa, fault tree, barrier analysis
3Human error and contributing factors
4Writing corrective and preventive actions that can be verified
5Effectiveness checks that prove something
6CAPA trending, overdue actions and management review
Scored final exam and dated certificate

What this course does and does not do

Covered

Root cause tools: 5 Whys, Ishikawa, fault tree and barrier analysis
Writing verifiable corrective and preventive actions
Effectiveness checks, trending and management review input

Not covered

Conducting or reviewing an investigation at your site
Your CAPA software, workflow or approval matrix
Statistical process control, which is outside this course

This course is professional training. It does not replace your site’s procedures, and it is not regulatory or legal advice on a specific event.

Who it is for

QA investigators
Team leads

Before you decide

Do you really need this course?

10 questions from real inspection findings. Three minutes. No sign-up.

Not started

Ten questions about whether your CAPAs actually remove causes or just close records. Written from the investigation and CAPA deficiencies inspectors cite most. Nobody sees your answers.

For managers

Rolling root cause and capa essentials out to a team?

The Site Readiness Programme adds a team heatmap from the self-assessment, a live session on the weakest questions, and records named by employee ID. Quote within two working days.

Seats for the whole team, with licences from ten seats
Anonymised team heatmap: which questions your people fail, by chapter
90-minute live session built on the team's weakest questions

See the programme

Regulations referenced

ICH Q10 Section 3.2.2
EU GMP Chapter 8
ISO 13485 Section 8.5

Founding price held until 30 December 2026

Per learner

€199

Root Cause and CAPA Essentials, 6 lessons, knowledge checks, 12 months access · €199
Worked examples and knowledge checksEvery lesson runs on a real situation, with checks that ask you to make the call rather than recall a definition.
Template packThe report, assessment and investigation templates from the free resources, annotated with what a reviewer looks for in each field.
Before-and-after readiness scoreRetake the self-assessment after the course. Keep both scores as evidence of the gap you closed.
12 months of access, with author Q&AIncluding any updates made during that period. Ask the course author about your own deviations, changes and records.
Dated certificateNames the learner, the course and the exam result, with a unique ID any employer or auditor can check. Supports the training records EudraLex Volume 4 Chapter 2 expects you to keep.

Still under 75% on the retake? Tell us.

Finish the course and retake the chapter assessment. If you still score under 75%, email us with the questions you missed. We will point you at the material that covers them, and if it is quicker to talk it through, we will arrange a call.

Reserve the founding price

Opens truex-consultancy.com, where the course is delivered. Not open for enrolment yet: the founding list holds €199 until launch.

See a sample lesson

Training a team? See the Site Readiness Programme