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 Our GMP in-house training helps your employees to put the GMP requirements into practice, to understand why they have to observe
GMP rules and to develop a positive attitude towards GMP. In the
discussion of topical questions, the participants become familiar
with the GMP rules, and solutions to concrete problems are found.
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The requirements for the GMP-compliant manufacture of drug products
are laid down in the EU GMP Guide. Chapter 2 says that: "The
manufacturer should provide training for all the personnel whose
duties take them into production areas or into control laboratories
(including the technical, maintenance and cleaning personnel), and
for other personnel whose activities could affect the quality of the
product." |
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In the US, the CGMP Guide published by the FDA defines in 21 CFR §
211.25: "Training shall be in the particular operations that the
employee performs and in current good manufacturing practice
(including the current good manufacturing practice regulations in
this chapter and written procedures required by these regulations)
as they relate to the employee's functions. Training in current good
manufacturing practice shall be conducted by qualified individuals
on a continuing basis and with sufficient frequency to assure that
employees remain familiar with CGMP requirements applicable to
them." |
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We orientate the courses towards the individual needs and ideas of a
company. The course takes account of the specific situation in the
company and of the latest GMP publications. We elaborate a training
course whose structure, contents and level are tailored to the
target group - also considering group-dynamic effects.
- Please
click here to see the list of in-house training courses that we offer.
- If
you are interested in one of our in-house courses, please contact us by
e-mail.
-
Click
here to download a PDF version.
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Our GMP trainers have been working for us as speakers over many years.
Only GMP trainers who have performed successfully at our open GMP
Education Courses or European Conferences can conduct in-house
training courses as associated partners. Each special field is
covered by a different trainer. In this way we ensure that you have
a competent GMP trainer, no matter if the course is about current
Part 11 trends or about cleanrooms for aseptic manufacture. |
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 Over a period of 25 years, we have organised both in-house training
courses and open seminars on GMP and Regulatory Affairs for about
50,000 employees in the pharmaceutical industry. At present, CONCEPT
HEIDELBERG is the leading organiser in the fields of pharmaceutical
and biopharmaceutical production and quality assurance in Europe.
Our pharmacists, chemists, biologists and pharmaceutical engineers
are responsible for about 50 GMP in-house training courses and 200
open GMP seminars in 11 European countries per year.
Our top events are organised for up to 250 participants. Among the
team of ca. 500 speakers, there are experts from almost all of the
leading manufacturers of pharmaceutical or biotechnological products
and APIs. In addition, speakers from the FDA (USA), the BfArM (D),
the MPA (S), MHRA (UK), Swissmedic (CH) and many other medicines
authorities regularly give lectures at CONCEPT HEIDELBERG events.
CONCEPT HEIDELBERG is a partner of the European Compliance Academy
(ECA). In addition to the open events, the co-operation is extended
by means of the joint in-house training concept for the European
pharmaceutical and API industry. |
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Every participant receives a folder with detailed training
documentation. As a recognised institution for further education, we
issue certificates that document the participation in the training
measure and that are accepted by the supervisory authorities. |
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