DEVPractitionerDeviation Management Essentials
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

Every course ends with a scored final exam and a dated certificate you can verify. Start with the five published Essentials courses, or join a waitlist and shape what comes next.
Deviations feed changes, changes cause deviations, and both end in CAPA, complaints or a recall. Each course is €199 per learner at the founding price. Training a team? Licences start at ten seats, with completion records for your training matrix.
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
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
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
5 courses enrolling now, 6 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.
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.