As a Qualified Person for several Clinical Research institutes, I’ve specialized over the years in building up a Pharmaceutical Quality System on a shoestring. This implies making choices and putting the money where it’s best spend. I gained this experience in nearly 20 years working in different Quality roles for Big Pharma. My own company Eye-Tec provides specialized consultancy in the domain of Visual Inspection of parenterals – a unique and highly specialized service within the GMP world. Visual inspection is a challenging domain, not only as a regulatory ‘twilight zone’ but also because it is so technically advanced.