eLearning Course - GMP in Analytical QC
Course available in:
Staff working in a facility that manufactures pharmaceuticals or active pharmaceutical ingredients - specifically for staff in quality control.
Part 1: € 90,- plus VAT
Part 2: € 90,- plus VAT
Both parts: € 155,- plus VAT
Phone: +49 (0)6221 / 84 44 0
E-mail: info (at) concept-heidelberg.de
Part I – GMP (general)
The basic principles of GMP are explained in Part I. What does GMP mean? What is GMP used for? The subitem ‘personnel’ shows when GMP training is required and what hygiene measures must be taken to prevent the contamination of products. This includes protective clothing, no food and drinking and reporting illnesses. The importance of external inspections (FDA, PIC/S, EMA) and internal inspections (self-inspections) is also highlighted.
Part II – Analytical Laboratory
The “sample” section deals with correct sampling, including the use of the right sample container and the complete labelling of the sample container to specific storage conditions for sample containers and reserve samples. In the section “Analysis”, the emphasis lies on the GMP-compatible handling of reference standards as an important task in quality control.
The correct use of well-maintained and suitable instruments is the topic of “Equipment and Methods” as well as which tasks must be recorded into the log book in this area. In addition to the correct handling of out-of-specification results (OOS), GMP-compatible documentation, including specifications and raw data, also forms an important part of this analytical part.
Video extract from the eLearning course GMP in Analytical QC
music by musicfox.com
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