VAL In development

Qualification and Validation

Equipment, utilities, process and cleaning validation under Annex 15, and how to keep the validated state through change.

Duration: 3 hours
Level: Practitioner
Lessons: 6 lessons

Join the waitlist Do I really need this course?

This course is being written now

Qualification and Validation is in development. Waitlist members receive the launch price, an early look at the curriculum and a chance to tell us which situations from their own site the course should cover.

What this course does and does not do

Covered

The validation lifecycle from user requirements to periodic review
Equipment, process, cleaning and computerised system qualification
Change control of the validated state

Not covered

Writing or approving protocols for your equipment
Statistical design of experiments
Engineering commissioning activities outside GMP qualification

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

Validation and engineering
QA reviewers

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 validated state would survive an Annex 15 review. Written from the qualification and validation deficiencies inspectors cite most. Nobody sees your answers.

For managers

Rolling qualification and validation 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 Annex 15
EU GMP Chapter 3
ICH Q9

Price at launch

TBC

Qualification and Validation, 6 lessons, knowledge checks, 12 months access
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.

Training a team? See the Site Readiness Programme