Every course ends with a scored final exam and a dated certificate you can verify. Start with a published course, or join a waitlist and shape what comes next.
Deviations feed changes, changes cause deviations, and both end in CAPA, complaints or a recall. All five courses in one enrolment for €695 excl. VAT (€840.95 incl. 21% Dutch VAT) instead of €895. Training a team? €145 per learner excl. VAT, from 5 learners, with completion records for your training matrix.
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
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
Turn investigations into corrective and preventive actions that address the cause and can be shown to have worked.
6 lessons · knowledge checks · scored final exam
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
Management review as EU GMP and ICH Q10 expect it to work: what it is for, the inputs it needs, how to run it so it decides things, the outputs it must produce, and how to close the loop so the quality system actually improves.
5 lessons · knowledge checks · scored final exam
The life of one GMP record as EU GMP expects it to run: made at the time under your own name, corrected so the original can still be read, reviewed in the system rather than on the printout, and kept readable for as long as it has to last.
5 lessons · knowledge checks · scored final exam
How to prepare people, documents and the site for internal audits and regulatory inspections, and how to behave in the room.
Curriculum in development · waitlist open
Equipment, utilities, process and cleaning validation under Annex 15, and how to keep the validated state through change.
Curriculum in development · waitlist open
Phased out-of-specification investigations, retest rules, hypothesis testing and reporting that survives an inspection.
Curriculum in development · waitlist open
Qualifying suppliers and contractors, writing quality agreements that work, and keeping oversight without living on site.
Curriculum in development · waitlist open
Take a complaint in, record it so it can be investigated, judge whether it signals a quality defect, and close it with a conclusion that holds.
6 lessons · knowledge checks · scored final exam
Decide when a defect needs a recall, notify the competent authority, execute the recall and reconcile what came back against what was distributed.
6 lessons · knowledge checks · scored final exam
8 courses enrolling now, 4 in development. Each chapter links to its free self-assessment so you can check where you stand before you buy anything.
Nobody needs every course. Pick the description closest to your job and get a recommended order.
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.
The life of one GMP record as EU GMP expects it to run: made at the time under your own name, corrected so the original can still be read, reviewed in the system rather than on the printout, and kept readable for as long as it has to last.
Detect, document, investigate and close deviations the way inspectors expect to see them, with clear ownership and defensible impact assessments.