Dr. Iris Bensen-Retzko
Chemist | Psychologist

After several years in research, with over 30 publications, I am working in leading positions in various quality management systems, since 1998: analytics, medical devices, pharmaceuticals and their suppliers, e.g. ISO 17025 (Accredited Testing Laboratory), ISO 9000ff, ISO 13485 and US and EU GMP. This includes international project management in Europe, USA and Japan.

Since January 2006 I am working as independent business consultant. I plan, coordinate and work on QM projects and regulatory topics in the pharmaceutical and medical device industries. So far, I have prepared numerous companies in Germany and Switzerland for FDA inspections, according to, e.g., 21 CFR Parts 4, 11, 210/211, 820, and supported them during the inspection in the front-office or back-office. My work areas include, in addition to GxP / ISO-based quality management and regulatory affairs (drugs & medical devices), topics of work and organizational psychology as required by the current standards DIN EN ISO 9001:2015 or 13485:2016, e.g., communication, leadership, quality consciousness, as well as audit psychology.

I am a qualified stress management trainer (program according to Prof. Dr. Gert Kaluza) and was for two years (2018 - 2020) lecturer for "Quality Management" at a private educational institution in Berlin.

My working languages: German, English