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Why
GMP In-house Training?
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.
The
Regulatory Basis for GMP Training Courses In Europe
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."
FDA
Requirements on GMP Training Courses
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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The Courses We Offer
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.
Professional
GMP Trainers
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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Why
CONCEPT HEIDELBERG?
 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.
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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.
Documentation
and Certification
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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