Erfolgskontrolle von GMP-Schulungen im Produktionsumfeld
GMP / GLP / GCP
2. Material und Methoden
3. Ergebnisse
4. Diskussion
5. Ausblick
Abstract
GMP Training in Pharmaceutical Production – Evaluation of Success
For some time pharmaceutical manufacturers have faced the need for examination of their GMP trainings demanded by several health authorities. Neither implementation nor performance review are defined in the relevant regulations which leaves space for definition to the manufacturer.
The present study developed a concept for implementation of a standard method for performance review of GMP-trainings in the environment of pharmaceutical production. Several approaches were tested and compared: The well-known multiple-choice test, a creative method in which employees develop own questions for performance measurement, and an e-voting system. Evaluation criteria were efficiency, suitability and balance of effort/benefit.
The comparison showed that the e-voting system used seemed to be the most suitable method. It has been rated best in almost all investigated aspects and shows additional benefits by saving time and effort.
 | Saskia Kind hat das Studium der Pharmazie an der Friedrich-Schiller-Universität in Jena mit dem zweiten Staatsexamen abgeschlossen und befindet sich im praktischen Teil ihrer pharmazeutischen Ausbildung, der ein Jahr dauert. Das Manuskript der vorliegenden Arbeit entstand während ihres Wahlpflichpraktikums im Hauptstudium, das Sie in der Tablettenherstellung der Boehringer Ingelheim Pharma GmbH & Co. KG durchführte. |
 | Dr. Christoph Küster studierte in Frankfurt am Main Pharmazie und arbeitete anschließend |
