Michael Schousboe

  PhotoMichael Schousboe holds the title of Senior QbD Manager, Principal Scientist in within the department Manufacturing Science and Quality part of Global Quality of Novo Nordisk. His main areas of responsibility are Quality by Design and process analytical technology (PAT), Validation Non Conformities Analytical instrument qualification among others. He is currently the project manager of global implementation of Quality By Design in Novo Nordisk. Michael Also serves as the chairman of the internal Focus Group regarding Quality by Design. Schousboe holds a Masters degree in pharmaceutical science (M.Sc. Pharm.) from the Royal Danish School of Pharmacy and has eleven years of experience within the pharmaceutical industry. With a QC laboratory background and later as a QA professional Schousboe has worked with qualification and validation within the areas of computerised systems, laboratories, as well as production of drug products and API in different Danish pharmaceutical companies, and he is experienced as a speaker on the aspects of validation, Quality by Design and Quality Management. Furthermore, Schousboe is an experienced auditor and has served as a qualified person. He is a member of the ASTM E55 Committee on Pharmaceutical Manufacture, and has participated in writing of the standard “Continuous Quality Verification” an the draft standard “Verification of PAT systems.”