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Events

Speaker at "Design Controls for Drug-Device Combination Products"

by Gerhard Bauer-Lewerenz • 9 July 2024
15 October 2024, online course
CAPA is a central element in QA, closely linked to other systems

Speaker at "GMP for Medical Devices" - a seminar by the European Compliance Academy

by Gerhard Bauer-Lewerenz • 7 January 2024
The CAPA-Process, Improvement, Design Controls, and the Regulatory Pathway are an integrated concept.
Risk Management for Drug-Device Combiantion Products

Speaker at "GMP-Auditor/in für Medizinprodukte"

by Gerhard Bauer-Lewerenz • 25 August 2022
Praxisbeispiele: Einstufung von Beobachtungen, CAPAs und Wirksamkeitsprüfung
Risikoanalysen für Medizinprodukte/risk analysis for medical devices

Speaker at Seminar "Qualifizierung und Validierung von Medizinprodukten"

by Gerhard Bauer-Lewerenz • 23 August 2022
Risikobegriff ganz allgemein, Methoden der Risikoanalyse, Einsatz bei der Qualifizierung.
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