The GMP knowledge hub for pharma, biotech and medical devices.
Courses written by practitioners, not by a content agency. Learn how the quality system works when an inspector is reading your report.
Every course is mapped to the regulations you are inspected against
Referenced for educational context. No regulator endorses or accredits training providers.
Deviations, changes, root cause, complaints and recall: the five quality system events that decide most inspection outcomes, each from the first phone call to the closed record. And the records behind all of them: how a GMP record is made, corrected, reviewed and kept.
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
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
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
Join a waitlist and you will get the launch price and a say in what goes into the course.
The principles behind every rule: quality systems, personnel, premises, documentation and the batch record from start to release.
Curriculum in development · waitlist open
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 chapter of the free self-assessment, or go straight to a course if you already know the topic.
Pay once per course, or take the whole Essentials Series in one enrolment. Teams buy seats from 5 learners, with a manager view.
Short modules built on real deviations, changes and inspection findings. Twelve months of access.
Clear the end-of-course assessment and download a certificate with a unique, verifiable ID.
Employers can check any certificate on the verification page.
Nobody needs every course. Pick the description closest to your job and get a recommended order.
The principles behind every rule: quality systems, personnel, premises, documentation and the batch record from start to release.
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.
72 scenario questions across the nine chapters of EU GMP Part I, each with the clause behind the answer. Take one chapter or all of them, then get a course recommendation matched to your gaps. No sign-up.
All nine chapters, 72 questions, about 45 minutes. Pause any time; progress is saved. Get a readiness score, a chapter heatmap and a course recommendation.
What the inspector wrote, why, and what would have prevented it. The fastest way to learn what gets cited.
Investigation of anomalies: inadequate root cause analysis
Deviation DEV-24-0187 concluded that the root cause was operator error and the CAPA was retraining of the operator concerned. The same failure mode had been recorded in three previous deviations in the preceding fourteen months, each with the same conclusion and the same corrective action. No assessment of contributing factors, procedure design or equipment had been performed.
Read the breakdownDeviation handling: impact on other batches not evaluated
A temperature excursion in cold store CS-02 was recorded as a deviation against batch 4471 only. Twelve other batches of four products were stored in CS-02 during the excursion window. No assessment of impact on these batches was performed and two of them were subsequently certified and distributed.
Read the breakdownComputerised systems: data integrity, access control
The chromatography data system in QC laboratory 2 was accessed using a shared account 'QCLAB' whose password was known to all analysts. Electronic signatures applied under this account could not be attributed to an individual. The audit trail showed 214 result approvals under the shared account in the review period.
Read the breakdownRoll out Deviation Management and Change Control across QA, production and engineering, and walk into the inspection with the training records already in the matrix.
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A short breakdown of a real regulatory finding, what went wrong and what would have prevented it. Plus early access when a new course opens.