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DEVOpen for enrolment

Deviation Management Essentials

Detect, document, investigate and close deviations the way inspectors expect to see them, with clear ownership and defensible impact assessments.

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

What the course teaches and assesses

  • Apply a risk-based method for classifying a deviation by criticality
  • Draft a deviation report a reviewer can follow without asking what happened
  • Run a structured investigation and separate root cause from symptom
  • Set out product, patient and process impact against the evidence you hold
  • Explain how a deviation connects to CAPA, change control and batch disposition

Lessons

  1. 1What counts as a deviation and what does not
  2. 2Immediate actions and containment
  3. 3Classification: minor, major, critical
  4. 4Investigation tools: 5 Whys, Ishikawa, timeline analysis
  5. 5Impact assessment and batch disposition
  6. 6Writing the report and closing the loop
  7. Scored final exam and dated certificate

What this course does and does not do

Covered

  • Detecting, recording and containing a deviation
  • Classification, investigation method and impact assessment
  • Closure, CAPA linkage and trending

Not covered

  • Your site's own deviation procedure, forms or QMS software
  • Batch disposition decisions, which remain with your QP
  • Legal or regulatory advice on a specific event

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 and QC staff
  • Production supervisors
  • Anyone who raises or investigates deviations
Before you decide

Do you really need this course?

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

Not started

Ten questions from the deficiency categories that recur in EU and UK GMP inspection reports. A yes to most of them is a finding waiting to be written. Nobody sees your answers.

For managers

Rolling deviation management 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

  • EU GMP Chapter 1 and Chapter 8
  • EU GMP Annex 16, Section 3
  • ICH Q9 (R1) Quality Risk Management
  • ICH Q10 Pharmaceutical Quality System

Continue the path

CCFoundation
Open for enrolmentAbout 2 hours, self-paced

Change Control Essentials

Raise, assess, approve, implement and close changes on a GMP site without losing control of the validated state.

5 lessons · knowledge checks · scored final exam

€179excl. VATView course
GMPFoundation
Open for enrolmentAbout 1 hour of core reading, self-paced

GMP Fundamentals

A short, complete introduction to Good Manufacturing Practice, told as the life of one batch: why it has to be right, the people who make and control it, the building and equipment it is made in, how it is made and recorded, and what has to be true before a Qualified Person can release it.

5 lessons · knowledge checks · scored final exam

€179excl. VATView course