The students are familiar with national and international quality assurance systems and concepts for biomedical analysis, consumer health protection and forensics. Students have the ability to test bioanalytical methods for their validity and robustness. They are also able to test analytical devices for their performance using validated documentation systems.

Modules of semesters 1- 4

• Quality concepts, quality and quality assurance, international and national standardization of specific quality assurance programs (internal, external quality assurance)
• National and international standardization for quality assurance in biomedical analysis, hygiene monitoring, drinking water analysis, food analysis, safety and monitoring
• Quality assurance concepts for consumer health protection, medical devices including IVD and forensics
• Industrial quality assurance concepts such as GCP, GMP, GLP
• Method and device validation, evaluation of methods and procedures / devices (evaluation criteria of an analysis system: precision and correctness, linearity, specificity and sensitivity, analytical limits, carryover effects, capacity of an analytical system, method hierarchy), test methods for biomedical analysis

Ertl-Wagner B. et al. (2013), Qualitätsmanagement und Zertifizierung, Springer;
Klusen N. et al. (2011), Qualitätsmanagement im Gesundheitswesen, Normos;
Rebscher H. & Kaufmann S. (2011), Qualitätsmanagement in Gesundheitssystemen, medhochzwei;
Schuhmann H. (2010), Grundlagen der Qualitätssicherung und Qualitätsmanagement im Gesundheitswesen, Grin Verlag;
Books, journals and websites according to the current state of knowledge in the respective fields.

Lectures

Module examination