Our training draws on practical delivery experience and focuses on how requirements are interpreted, implemented and evidenced.
Every module opens with a situation that occurred in practice, works through why the standard approach did not prevent it, and ends with the changes a team can make immediately.
Beyond the acronym: how ALCOA+ is assessed on a chromatography data system, an ERP and a SCADA historian — three systems where the same principle produces three different answers.
Critical thinking and risk-based testing in practice. Where CSA reduces effort, where it does not, and how to defend a reduced test set when the inspector asks why.
Supplier assessment, the shared-responsibility boundary, and what qualification evidence you can and cannot inherit from the provider. Includes the questions to put in the contract before signature.
Intended use, model qualification, explainability and change control for systems that update themselves. Which use cases belong in GxP scope and which should be kept outside it.
An audit trail review programme can produce evidence of review without being capable of detecting an event. How to design one that is both proportionate and effective.
We take your own systems, your own SOPs and a recent finding, and build the session around them. Requires a short scoping call and an NDA.
Scheduled sessions, individual seats.
One client, your site, your systems.
Training requests usually come from something that happened. If you tell us what it was, the session will be worth considerably more than a standard module.