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Speaker at Seminar "Qualifizierung und Validierung von Medizinprodukten"

Gerhard Bauer-Lewerenz

Lectures: Risik analysis, validation master plan

19-20 February 2025 | Concept Heidelberg 

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

von Gerhard Bauer-Lewerenz • 9. Juli 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

von Gerhard Bauer-Lewerenz • 7. Januar 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"

von Gerhard Bauer-Lewerenz • 25. August 2022
Praxisbeispiele: Einstufung von Beobachtungen, CAPAs und Wirksamkeitsprüfung
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