Yves M. Samson Dipl. Ing. FH

Yves Samson initially graduated as automation engineer and computer scientist. After his studies in Grenoble (France) and Münster (Germany), he joined Novartis (formerly Ciba-Geigy) in 1989 where he worked during 11 years as application engineer for process control systems, project engineer, technical project manager, and site engineer (maintenance & projects).

Yves takes care of computerised system validation since 1992. Since 2000, he works as consultant, auditor and trainer for all aspects of quality management in OT and IT environments particularly within the regulated industry – pharmaceutical industry, medical device manufacturing, blood transfusion services, ATMP manufacturer – and for its suppliers.

He supports Quality Assurance and development departments as well as IT and engineering organisations regarding e-compliance and data integrity for automated and IT/OT systems and the supporting infrastructures.

In 2002, he founded the consulting company Kereon AG, Basel, Switzerland.

Yves is strongly engaged within ISPE; he translated and edited the French version of GAMP® 4 and GAMP® 5 FE. He is also member of the French affiliate board. Yves is co-founder and chair of the French Speaking GAMP® Community of Practice “GAMP® Francophone” and member of the GAMP Europe Steering Committee; he is as well an active member of ISPE France Affiliate board.

Since 2004, Yves is industry lecturer for master students at the Université de Haute Alsace (UHA), Mulhouse, France, about "Good Software Engineering Practice".

Since 20+ years, Yves gives regularly numerous trainings around e-compliance, CSV, Data Integrity, Risk Management, and PQS.

He is member of the Pharmaceutical Consulting Alliance (PCA).