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CAPAOpen for enrolment

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

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

  1. 1When an investigation needs a CAPA, and when it does not
  2. 2Root cause tools: 5 Whys, Ishikawa, fault tree, barrier analysis
  3. 3Human error and contributing factors
  4. 4Writing corrective and preventive actions that can be verified
  5. 5Effectiveness checks that prove something
  6. 6CAPA trending, overdue actions and management review
  7. 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, priced per learner from 5 learners
  • 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

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