Bernd Renger, PhD

Bernd Renger has been working as a freelance consultant since 2011. He specialises in the development of efficient quality assurance systems, the preparation and follow-up of inspection, the establishment of effective deviation management and the design of sterile and aseptic processes.

He works as a lecturer at the University of Sigmaringen and is the co-founder of the European QP Association.

Bernd Renger holds a PhD in Organic Chemistry. He started his professional career at Hoechst AG in pharmaceutical research and transferred to the pilot plant at a later stage. He then became Head of Quality Control at Mundipharma. He subsequently held positions as Head of Department/VP Quality Control and Assurance at Byk Gulden, Baxter BioScience and most recently at Vetter Pharma-Fertigung. Bernd Renger has also worked simultaneously as Head of Quality Control since 1986 and later as a Qualified Person.

Bernd Renger has written widely on chemical and analytical issues. His publications also deal with topics such as deviation management, quality assurance systems or the tasks of the Qualified Person. He also gives presentations and provides in-house training in these areas. In addition, he carries out international audits of contract manufacturers as well as manufacturers of active ingredients and excipients.

He is author or co-author of the following chapter of GMP Compliance Adviser:

1.C Quality Assurance Duties

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