Every site manages risk. Quality risk management is the difference between managing it by habit and managing it by a method you can explain to an inspector, a Qualified Person or yourself in a year's time.
A short, complete course on quality risk management as EU GMP expects it to work: the two principles, a risk assessment that starts with a proper question, control, communication and review, choosing the right tool and level of formality, and building it into deviations, change control and supplier management so that the assessment informs the decision rather than following it.
Quality Risk Management Essentials is not open for enrolment yet. Join the waitlist and we will email you when it opens. Waitlist members receive the launch price, an early look at the curriculum and a chance to tell us which situations from their own site the course should cover.
Notify me when it opensThis course is professional training. It does not replace your site’s procedures, and it is not regulatory or legal advice on a specific event.
The Site Readiness Programme adds a team heatmap from the self-assessment, a live session on the weakest questions, and records named by employee ID. Quote within two working days.
A short, complete course on the product quality review (PQR) as EudraLex Volume 4, Chapter 1 expects it to work: knowing what it is for and who owns it, gathering the twelve inputs, finding the trends hidden in the data, drawing conclusions with actions or written reasons, and making sure management and the Qualified Person use what it found.
Curriculum in development · waitlist open
A short, complete course on sterile manufacturing as EudraLex Volume 4, Annex 1 expects it to work: building a contamination control strategy, designing premises and barriers, qualifying and guiding the people who work near open product, monitoring the environment and the aseptic process, and bringing it all together in the decision to certify a batch.
Curriculum in development · waitlist open
A short, complete course on the life of one batch record as EudraLex Volume 4 expects it: what the record must hold, how to review it as evidence, how to link every deviation, out of specification result and change to the batch, what the Qualified Person must be able to rely on, and how certification and release actually happen.
Curriculum in development · waitlist open