Training written by the people who do the work. Four levels across every GxP discipline, from a fifteen-minute essentials guide to a two-day practitioner course. Each item is authored, reviewed by a named specialist in that discipline, approved and reviewed annually — controlled the same way we control a procedure.
Level 1 is open now: seven free essentials guides, one per discipline, available immediately with no sign-up required. Levels 2 to 4 are in development — browse the full course catalogue, see pricing by territory, and pre-register for the topics that matter to you. What you register for shapes the order we build them in.
The four levels
1 · Essentials
A free two-page guide, about fifteen minutes. Available now for all seven disciplines and emailed to you straight away. No assessment.
Browse the course catalogue →2 · Intermediate
An online course of one to two hours, four modules. Twenty-question test, pass mark 80%. Verifiable e-certificate.
3 · Advanced
Three to six hours, case-based, five modules including a worked inspection case study. Case assessment. Verifiable e-certificate.
4 · Practitioner
One or two days, classroom or live online, with a practical exercise. Certificate and portfolio entry.
Disciplines
GMP
The quality system in practice, deviations and CAPA, change control and validation, batch records and release. Advanced adds risk-based validation, complex investigations, supplier qualification, self-inspection that finds real issues.
GDP
The RP role, supplier and customer qualification, temperature control and excursions, returns, recalls and falsified medicines. Advanced adds transport lane qualification, diversion risk, 3PL oversight.
GPvP
The PV system and the UK QPPV, case intake and ICSR timelines, literature searching, safety data exchange agreements. Advanced adds signal detection, PSURs and risk management plans, keeping the PSMF current.
GCP
ICH E6 principles and participant safety, the roles of the sponsor, the contract research organisation (CRO) and the investigator, consent and protocol deviations, safety reporting. Advanced adds risk-based monitoring, sponsor oversight, an inspection-ready trial master file (TMF) and bioequivalence essentials.
GLP
OECD principles, Study Director and QA roles, study plans, raw data and reports, archiving. Advanced adds QA inspection programmes, multi-site studies, computerised systems.
Data integrity
ALCOA+ in everyday work, good documentation habits, paper and electronic records, corrections and true copies. Advanced adds data governance, audit trail review, spreadsheets, investigating an integrity issue.
Biologics
What makes biologics different, cell banks and viral safety, contamination control, the cold chain. Advanced adds comparability after process change, characterisation, biosimilar development in the UK.
How we write it
Everything is written in our own words and cited, never copied from guidelines, books or other courses. Official UK and EU material is reused under its own open licence with attribution. Every item carries this line, and we mean it: this is our own summary and interpretation of the sources listed. It is not an official text and not legal or regulatory advice. Always consult the current official source.
Register your interest
Tell us which discipline and level you need, and pre-register via the GxP Academy Catalogue. Your pre-registrations shape the order we build them in. We will write to you as each topic launches.