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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, 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

  • 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

CCPractitioner
Founding list open2.5 hours, self-paced

Change Control Essentials

Plan, assess, approve and verify changes to facilities, equipment, materials, processes and systems without losing control of the validated state.

6 lessons · knowledge checks · scored final exam

GMPFoundation
In development2 hours

GMP Fundamentals

The principles behind every rule: quality systems, personnel, premises, documentation and the batch record from start to release.

Curriculum in development · waitlist open

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