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Felix Kern
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Felix Kern

Head of Compliance (Associate Director), Merck KgaA.

Published articles

Substance-based medical devices

Substance-based medical devices

The differentiation between medical devices and medicinal products is a constant challenge for pharmaceutical manufacturers. Does my product meet the definition of a medical device according to the EU Medical Device Directive (MDD) or the definition of a medicinal product according to EU-Directive 2001/83 for medicinal products?

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Smart Deviation Management – Vision or Reality?

Smart Deviation Management – Vision or Reality?

The GMP-compliant and timely management of deviations is very often addressed in audits. One reason for this is that deviations reveal gaps in the defined quality systems or indicate that they have not been set up correctly.

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Deviation Causes as KPIs – Collection vs. Assessment

Deviation Causes as KPIs – Collection vs. Assessment

Deviation management plays an increasingly important role in the collection and review of KPIs (Key Performance Indicators) for pharmaceutical production and quality processes. Tracking the cause of deviations in particular provides information on how stable the respective processes are, where there are gaps and where countermeasures need to be taken with corrective and preventive actions (CAPAs).

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