There we were, in the ‘quartier Polytech’, looking for the department ‘Aérospatiale & Mécanique’ at the university of Liège. We had gotten up way too early in the morning, but a small holiday feeling at 8 AM on Monday was our reward, as we crossed the language border – Liège is located in the French speaking part of Belgium, while QbD is headquartered in Flanders – and entered the beautiful landscape of the Ardennes.
”Est-ce qu’il y a des toilettes ici?” was the only French we spoke all day. We may know a lot about quality management systems, but my French is dusty at best… Luckily we were asked to do our presentation in English.
Theory in practice
But, why were we there in the first place? Well, Quality by Design was invited to give several guest lectures to future biomedical engineers. This semester these students were instructed to develop a medical device themselves. While universities are very good at teaching theory, the practical stuff is often a whole different ballgame. So they called QbD to the rescue!
Thanks to several lectures – such as ‘Roadmap to CE marking’, ‘ISO 13485’, ‘FDA & Medical Devices’ and ‘Intro in validation’ – the students won’t only know what it takes to design and develop a medical device, but will also learn what it takes, regulatory and quality-wise, to bring it to the market. They will end this journey with an external company visit to introduce them to the real world.
Intro in QMS and GMP
We (Michiel Van Pee and Kato Deckers) gave the very first lectures of this QA/RA (Quality Assurance / Regulatory Affairs) program. The first topics were ‘Intro in QMS’ (Quality Management System) and ‘Intro in GMP’ (Good Manufacturing Practices). Saying that the students were heavily interacting and participating would be an exaggeration – they were very, uhm, student-like. But that didn’t stop Michiel and me from vigorously explaining everything. We enthusiastically fired new terms, examples, and information at them which they all absorbed with pleasure.
They got a taste of the Big QA and Regulatory world that exists out there and they now know what to expect in the following lectures. Quality by Design will make sure they will gain some hands-on and relevant knowledge on QA, RA and medical devices and on what needs to be done to bring a perfect design to the market!