eLearning Course - Failure Investigation

Details

This course comprises practical examples of failure investigations in facilities. Different deviations in the production process are shown (contaminated sample, deviating ph value, deviating temperature sequence, deviating analysis result etc.). The aim is to find the relevant causes of these discrepancies. To do this, scenes must be checked for correctness and has to be evaluated. Entries in log books may also provide indications of non-compliant processes. A particular emphasis is placed on the importance of validating manufacturing processes.

Correct behaviour during inspections from authorities is also shown. Specifically, the module looks at a situation in the field of receipt of goods and how the responsible staff should have answered correctly during the inspection by the authorities.

In the past, course n° 9 "Failure Investigation" was part of course n° 6 "GMP in Analytical QC". As the content of the course gives a general view of GMP / QC topics and is not specialised on quality control, it has been separated.