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.
ContentWhat is a deviation?
What are the differences between deviations and changes?
with interactive exercises
Documentation of deviations
How are deviations documented?
Evaluation of deviations
How are deviations assessed?
Root cause analysis
Why try to find the cause of the deviation?
Corrective and preventive measures, CAPA
Completion of the investigation
When can the investigation be completed?
CAPA effectiveness check
Trainingszeit der Aktivität
Die geplante Trainingszeit sind 90 Minuten. Der tatsächliche Zeitaufwand hängt sehr vom Ausbildungsstand und den Praxiserfahrungen des Lernenden ab!