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.
Details
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.
Certificate
Attendance certificate from CONCEPT HEIDELBERG
Costs - individuals
Part 1: € 90,- plus VAT
Part 2: € 90,- plus VAT
Both parts: € 155,- 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.
