Failure Investigation

Target Group

Members of staff who work in a facility that manufactures pharmaceuticals or active pharmaceutical ingredients.

Prior Knowledge:
No prior GMP knowledge is required.

Languages available:
German and English.

Special Features:
This E-Learning course uses videos from real GMP facilities!

Study Time:
1 hour
We recommend a maximum of three practical situations per session.

Questions to:
Phone +49(06221 / 84 44 0 - e-Mail: info (at) concept-heidelberg.de



Do you want to book this course for more than 10 employees?
Send us an inquiry with the title of the course and the number of participants. We will make you a special offer.


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 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.

Attendance certificate from CONCEPT HEIDELBERG

Costs - individuals
€ 75,- plus VAT

Costs - company licence
Companies which yearly train more than 50 employees can aquire a company licence. Depending on the use, courses can be carried out for under € 30,- per training hour.



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