Programme Overview GMP eLearning Mediavision and online Training

The production of medicinal products and APIs must be carried out in accordance with the so-called Good Manufacturing Practices (GMP) requirements. GMP is the Good Manufacturing Practice and thus the sum of all measures that ensure that the medicinal product is produced in a reproducible quality.

Worldwide, there is a whole series of GMP guidelines, GMP directives and GMP guides. However, there is no harmonised GMP regulation, which is valid worldwide. There is no harmonised worldwide valid GMP regulation. The decisive factor is the market to which a medicinal product is supplied. If it is delivered to the USA, the 21 CFR Part 210/211 of the so-called cGMP Guide applies. This means that the manufacturing site is also subject to the GMP requirements of the FDA and is monitored by FDA inspectors. If the medicinal product is intended for the European market, the requirements of the EU GMP Guide and Annexes apply. In the individual Member States there are also implementing regulations.

Even if there are differences in detail, the principles are almost identical in all GMP guides. This applies, for example, to the necessary hygiene of the personnel, the requirements for the rooms and equipment, the documentation and the continuous GMP training of the personnel.

This is where the GMP eLearning System from Concept Heidelberg comes in.

The GMP eLearning MediaVision are courses that have been specially developed for employees in production, quality control, packaging and storage. They do not teach rules and regulations, but GMP in practice, i.e. videos from pharmaceutical companies are shown. The videos show which mistakes can happen and how to work according to GMP. These courses are therefore suitable for all employees in the GMP environment.

The GMP online Training is structured differently. Here, a moderator leads through the GMP contents like in a seminar and explains the structures and background of GMP. This seminar is suitable for employees and specialists who do not directly "put their hand on the product". GMP online Training can also be used for employees and specialists who are not directly involved in the GMP environment (e.g. purchasing, sales, management).