Brigitte Gübitz has almost 25 years industry experience in pharmaceutical and medical device production. For 20 years at VTU she holds an executive position and is responsible for the development and implementation of VTUs Risk Management Expert system REXS. Due to her strong background in quality risk management design and implementation, she supports national and international clients during implementing a life-cycle risk management process and moderates GMP-risk analyses according to the FMEA model. Brigitte is a certified GxP- and medical device auditor and an experienced GxP-trainer. PhD at Graz University of Technology “Risk management in Quality by Design”.