Quality management knowledge is expected of graduates from the life sciences, but is rarely taught at universities. This course provides an overview of key quality management systems (QMS) and related industry processes. It is designed to help participants better understand the requirements and keywords commonly found in job advertisements and to explore potential future career paths.

The course is divided into three session lasting 1.5h each and delivered over three days. The content of the three sessions is:

Good Laboratory Practice (GLP) is a quality management system that is used in certified laboratories. It is necessary, among other things, for the analysis of drugs in the development stage (animal (in vivo) and cell (in vitro) studies), but also for environmental safety tests. In this part of the course, the 10 basic principles such as the requirements for personnel, apparatus and measurement results are explained.

Good Clinical Practice (GCP) encompasses the ethical and scientific quality requirements for conducting clinical trials on humans. GCP is relevant for pharmaceutical companies and the contract research laboratories and clinics involved. After an overview of the different drug testing and approval phases, the guideline's most essential terms and content are explained.

Good Manufacturing Practice (GMP) includes guidelines for quality assurance in the production of pharmaceuticals, cosmetics, food and feed. Among other things, it regulates standard operation procedures, documentation requirements, the management of deviations and changes in the process, the qualification of systems and the validation of methods.

When: 10.02. + 11.02 + 13.02. from 9.00h – 10.30h (Tuesday, Wednesday, Friday)

Where: online (the link will be shared at a later point)

Target Group: all researchers wanting to receive a brief overview about this topic

Language: English

Free registration: send an email to Cathrin.Nourse@unimedizin-mainz.de