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Change Control Essentials

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

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

What the course teaches and assesses

  • Recognise when a change needs formal change control
  • Build a cross-functional impact assessment covering validation, regulatory and documentation
  • Distinguish like-for-like, minor and major changes and justify the call
  • Plan implementation, verification and an effectiveness check that can be measured
  • Describe how a change affects the validated state and the regulatory filing

Lessons

  1. 1Why changes fail: lessons from inspection findings
  2. 2Change classification and regulatory impact
  3. 3Impact assessment across QMS, validation and supply
  4. 4Approval, implementation and verification
  5. 5Effectiveness checks and closure
  6. 6Change control for computerised systems
  7. Scored final exam and dated certificate

What this course does and does not do

Covered

  • Proposal, classification and cross-functional impact assessment
  • Approval, the go-live gate and implementation verification
  • Effectiveness checks, closure and computerised system changes

Not covered

  • Preparing or submitting a variation to a competent authority on your behalf
  • Your site's change control procedure or electronic workflow
  • Engineering qualification protocols, which are covered separately

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

  • Quality assurance
  • Engineering and validation
  • Process owners and project 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 how changes actually move through your site. Written from the change control deficiencies inspectors cite most often. Nobody sees your answers.

For managers

Rolling change control 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 Annex 15
  • EU GMP Annex 15, Section 11
  • Regulation (EC) 1234/2008 on variations
  • ICH Q10 Section 3.2.3
  • ICH Q12 Lifecycle Management

Continue the path

DEVPractitioner
Founding list open3 hours, self-paced

Deviation Management Essentials

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

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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