After successful completion of the course, students are able to understand and to use methods and tools of quality assurance / qualicty control in the chemical laboratory and in a production environment. Particularly, they are able to calibrate and to validate analytical methds, and to estimate the uncertainty of analytical results. Furthermore, they know and understand the different quality assurance systems under which the work of analytical laboratories is to be performed in the various regulated and non-regulated environments.
Introduction to Quality Assurance (QA): Definition of quality, terms and concepts of QA; importance of QA in research and industry; necessity of QA in the regulated environment; cost-benefit analysis of QA measures; mathematical and statistical methods and tools of quality assurance; method validation; practical tools of quality assurance (control charts, (certified) reference materials, interlaboratory comparisons; ). Accreditation of testing and calibration laboratories and certification of production sites according to the relevant regulations (DIN, ISO, EN); audits and inspections in the laboratory or the factory; Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP).
Conventional lecture course format with numerous real-world examples and discussion items.
The lecture course will be held in German language in the winter semester, and in English in the summer semester.
Lecture notes (copies of PPT slides) will be made available via TUWEL to enrolled participants.
Oral exam (discussion), or preparation of a 'dossier' on a selected topic from the field of analytical QA/QC.
Not necessary
Lecture notes for this course are available.
As further reading, one of the two boks is recommended:- E. Prichard, V. Barwick: Quality Assurance in the Analytical Laboratory (Wiley & Sons, 2007)- E. Prichard: Quality in the Analytical Chemisty Laboratory (Analytical Chemistry by Open Learning) (Wiley & Sons, 1995)
Basic knowledge of analytical methofds and the analytical approach of problem solving.
