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PharmSchul
Legal Requirements
Besides multiple other regulatories like PIC, WHO, FDA and others the EU
Guidelines for Good Manufacturing Practice requires:
2.8 The manufacturer should provide training for all the personnel whose duties take them into production and storage
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.
Planing training efficiently and trainind documentation
In the context of national and international inspections the training plans and training execution need to be documented.
The EG-GMP-Leitfaden requires:
2.9 Besides the basic training on the theory and practice of the quality management system and Good Manufacturing Practice,
newly recruited personnel should receive training appropriate to the duties assigned to them.
Continuing training should also be given, and its practical effectiveness should be periodically assessed.
... Training records should be kept.
Futhermore today an efficient training plan is necessary due to the economical points of view.
Alternative to cost-intensive individual training solutions
If you calculate the costs of an indivdual internal training solution, the effort would be multiple days of programming except validation.
Our solution:
PharmSchul
a cost-efficient, GMP suitable standard programme, which can be implemented without big effort.
The IT system for planning, administrating and documenting GMP training with its modules.
The system is qualified for all companies, that need to implement a training system, which fulfills the requirements of GMP regulations.
Besides the pharmaceutical companies, these are also manufacturers of medical devices, active pharmaceutical ingredients and the cosmetic industry.
PharmSchul is validated based on the GAMP 4/5 guide.
GAMP 4/5 and also other Good Practice Guides (GPG) are the world wide accepted regulations for validating computerized systems.
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