Equipment, utilities, process and cleaning validation under Annex 15, and how to keep the validated state through change.
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.
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.
10 questions from real inspection findings. Three minutes. No sign-up.
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.
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.
DEVPractitionerDetect, 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
CCPractitionerPlan, 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
CAPAPractitionerTurn investigations into corrective and preventive actions that address the cause and can be shown to have worked.
6 lessons · knowledge checks · scored final exam