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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 one from the first phone call to the closed record.
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
CMPPractitionerTake 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
RECPractitionerDecide 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.
GMPFoundationThe principles behind every rule: quality systems, personnel, premises, documentation and the batch record from start to release.
Curriculum in development · waitlist open
GDocPFoundationALCOA+ in daily work: recording, correcting and reviewing records on paper and in electronic systems.
Curriculum in development · waitlist open
AUDAdvancedHow 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
VALPractitionerEquipment, utilities, process and cleaning validation under Annex 15, and how to keep the validated state through change.
Curriculum in development · waitlist open
OOSPractitionerPhased out-of-specification investigations, retest rules, hypothesis testing and reporting that survives an inspection.
Curriculum in development · waitlist open
SUPPractitionerQualifying 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 bundle two for 20% off. Teams get seats and 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.
GMP is one connected system. Understanding how a deviation feeds a change, how a change affects validation, and how all of it shows up in an inspection is what we teach.
Deviations, CAPA, change control and complaints. The core of every inspection.
ExploreALCOA+ on paper and in systems. Records that tell the true story.
ExploreContamination control, batch records, line clearance and process control.
ExploreSampling, testing, OOS investigations and stability programmes.
ExploreEquipment, process, cleaning and computerised system validation.
ExploreSelf-inspection, supplier audits and regulatory inspection conduct.
ExploreNobody 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.
ALCOA+ in daily work: recording, correcting and reviewing records on paper and in electronic systems.
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 bundled recommendation.
Most GMP training tells you the rule. Ours shows you the deviation report, the change request and the inspector's question, then teaches you what a defensible answer looks like.
Each module starts with what regulators actually cite, then works back to the practice that would have prevented it.
Deviation, CAPA, change control and validation are taught as one connected flow, because that is how inspectors read them.
Every requirement is tied to its clause in EU GMP, ICH or PIC/S so you can defend it in the room.
Pass the end-of-course assessment and receive a certificate with a unique ID your training matrix can reference.
We do not claim a percentage we cannot evidence. These are the metrics your own QMS produces, the state most sites are in before the training, and what a trained team should be able to hold afterwards.
Read it in: Deviation log, ageing report
Read it in: Trending report, management review
Read it in: Root cause field, closed records
Read it in: Change records, implementation dates
Read it in: CAPA closure records
Read it in: Self-inspection reports
Generic e-learning is cheaper and a classroom day is far more expensive. The difference is what you can show an inspector afterwards.
| Feature | This academy€199 founding price | Generic GMP e-learning€40 to €90 per learner | Classroom or consultant€1,200 to €2,000 per day |
|---|---|---|---|
| Every point cited to a clause | Yes, EU GMP, ICH and PIC/S, on every question | Rarely, and often to the wrong region | Depends entirely on the trainer |
| Built from published inspection findings | Yes, the findings library feeds the course | Generic scenarios | Sometimes, if the trainer brings them |
| Scenario questions, not definition recall | Every assessment question is a situation | Multiple choice on definitions | Discussion, rarely assessed |
| Before-and-after evidence of the gap closed | Self-assessment score before and after | Completion tick only | Attendance sheet |
| Templates you can use on Monday | Inspector-annotated pack included | No | Occasionally, as handouts |
| Training records for the matrix | Exportable per learner, with a verifiable ID | Certificate PDF | Attendance record |
| Cost of training twenty people | Per seat, with team pricing | Cheap, and usually repeated next year | A day of everyone's time plus the fee |
| Updated when guidance changes | Reviewed twice a year, included for 12 months | Whenever the vendor refreshes the library | Next time you book |
Comparison prices are the market bands quoted by other GMP training providers, not offers from a named competitor.
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 breakdownTap a term. The full glossary has over ninety, grouped by GMP chapter.
Open the glossaryAttributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring and Available. The principles of data integrity.
Roll out Deviation Management and Change Control across QA, production and engineering, and walk into the inspection with the training records already in the matrix.
If your question is not here, the contact page reaches a person, not a ticket queue.
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.