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Yves Samson, Founder and CEO, SME e-Compliance

Biography

Automation and system engineer, after his education in France and Germany, Yves Samson joined Novartis Pharma, Basel (formerly Ciba-Geigy) in 1989 where he worked during 11 years. He has been performing computerized system validation (CSV) since 1992.

Since 2000 Yves provides consulting, audit, project management and training services. In 2002 he founded the consulting company Kereon AG, Basle. Since 2004 he is industry lecturer at the Université de Haute Alsace (UHA), Mulhouse, for the Master 2 AII and in charge of the lecture about "Good Software Engineering Practice".

His customers are globally-acting pharmaceutical companies and their equipment suppliers and service providers, as well as smaller regulated organizations, blood transfusion services, and medical device manufacturers.

Yves is the editor of the French Version of GAMP® 4 and GAMP® 5 and he translated the PIC/S Guide PI 011 into French. He is the co-founder and chair of GAMP Francophone and member of GAMP Europe Steering Committee (GESC). He is was an active member of the ISPE IT infrastructure SIG and he is member of ISPE French affiliate board.

Activities

  • Consultancy: CSV, QMS
  • Auditing: CSV, QMS, GxP
  • Project support/coaching/management for automation, IT, validation projects
  • Training: CSV, Qualification, Validation, GxP (regulated Good Practices)

Diploma

  • Diplom Ingenieur FH (Certified Engineer) - Electrical Engineering / Automation (process control, industrial & process IT, software engineering)
    Fachhochschule Münster, Germany
  • Diplôme Universitaire de Technologie (DUT) - Electrical Engineering / Automation & System
    Institut Universitaire de Technologie Grenoble, France

Internet social networking

Yves is member of various professional networks:

... including ISPE's Communities of Practice as well.

Information


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Last update: 2017-01-01

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