Cleanroom training (Q3542887): Difference between revisions
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(Created claim: summary (P836): High standards (Good Manufacturing Practice-GMP) and extensive legal requirements must be met in order to ensure the protection of patients and other users when manufacturing products for medical technology that can affect people’s health and quality of life in the broadest sense. Therefore, extensive training is necessary for the employees, who work in the cleanroom areas and monitor the production. These trainings include validation, qu...) |
(Changed label, description and/or aliases in en: translated_label) |
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Cleanroom training |
Revision as of 23:12, 17 November 2021
Project Q3542887 in Germany
Language | Label | Description | Also known as |
---|---|---|---|
English | Cleanroom training |
Project Q3542887 in Germany |
Statements
2,207.74 Euro
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2,759.68 Euro
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80.0 percent
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7 May 2018
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30 September 2018
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Röchling Medical Neuhaus GmbH & Co. KG
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98724 Neuhausam Rennweg
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Bei der Herstellung von Produkten für die Medizintechnik, die im weitesten Sinn die Gesundheit und Lebensqualität von Menschen beeinflussen können, sind hohe Standards (Good Manufacturing Practice-GMP) und umfangreiche gesetzliche Vorgaben einzuhalten, um den Schutz der Patienten und anderen Anwender zu gewährleisten. Deshalb sind umfangreiche Schulungen für die Mitarbeiter notwendig, die in den Reinraumbereichen arbeiten und die Produktion überwachen. Diese Schulungen beinhalten u.a. die Validierung, Qualifizierung und Verifizierung der Bereiche und Produkte. Die hier geplante Maßnahme umfasst 4 Schulungstage. Der gewählte B-DKS wurde gewählt, weil er den Anforderungen am ehesten entspricht. (German)
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High standards (Good Manufacturing Practice-GMP) and extensive legal requirements must be met in order to ensure the protection of patients and other users when manufacturing products for medical technology that can affect people’s health and quality of life in the broadest sense. Therefore, extensive training is necessary for the employees, who work in the cleanroom areas and monitor the production. These trainings include validation, qualification and verification of the areas and products. The action planned here covers 4 training days. The selected B-DCS was chosen because it is most likely to meet the requirements. (English)
18 November 2021
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Identifiers
DE_TEMPORARY_ESF_138799
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