Everything you don´t learn in the lab

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 Steinhauser

Target group
MSc and PhD students, postdocs

Description

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 introduction to the various quality management systems (QMS) and industry-associated processes. The aim is to understand job advertisements’ requirements and keywords and better assess possible future professional fields.

Good Laboratory Practice (GLP)

This 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)

This 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)

This 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.

Already interested in jobs in the regulated environment? You might like our article Jobs in industry: quality management, regulatory affairs & health and safety.

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