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Online and/or in-house

Introduction to quality management systems (QMS)

Topic area: (Self-) management

Format: Online or in-house workshop

Workload: 3 webinars of 1.5 h each = 1 workshop day

Trainer: Lisa Steinauser

Target group: MSc and PhD students, postdocs

In many companies, quality management knowledge is expected of graduates from the life sciences, but is rarely taught at universities. For this reason, this course offers an initial overview of the various quality management systems (QMS) and the associated processes in industry. The aim is to understand the requirements and keywords in job advertisements and to be able to better assess possible future professional fields.

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. After an overview of the different phases of drug testing and approval, the most important terms and the content of the guideline are explained. GCP is relevant for pharmaceutical companies and the contract research laboratories and clinics involved.

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.

 

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