Deviations must be investigated!
Deviations must be reported and investigated. An assessment is to be made as to whether the deviation has an influence on the product quality. Corrective and preventive measures must be defined, implemented and tracked.
EU GMP Guide: Chapter 1
In this eLearning module, you will learn about the whole process of deviation testing, from notification to completion of the investigation, in accordance with Chapter 1 of the EU GMP Guide. You will also learn the differences between a deviation and a change.
Content
What is a deviation?Definition deviation
What are the differences between deviations and changes?with interactive exercises
Quality managementHandling deviations
Documentation of deviationsHow are deviations documented?
Evaluation of deviationsHow are deviations assessed?
Root cause analysisWhy try to find the cause of the deviation?
Corrective and preventive measures, CAPACAPA
Corrections
Corrective measures
Preventive measures
Completion of the investigationWhen can the investigation be completed?
TrackingCAPA effectiveness check
Trainingszeit der Aktivität
Die geplante Trainingszeit sind 90 Minuten. Der tatsächliche Zeitaufwand hängt sehr vom Ausbildungsstand und den Praxiserfahrungen des Lernenden ab!