Gert Moelgaard is Vice President for Innovation & Business Development in NNE Pharmaplan. He has been working in the pharmaceutical industry for more than 25 years and has experience from a number of major engineering, automation and validation projects within pharmaceutical manufacturing. He has made international contributions in international conferences on automation, GAMP (Good Automated Manufacturing Practice), process validation, PAT, manufacturing excellence and Quality by Design. He has contributed to several books and technical guidelines. Gert Moelgaard is a past chairman of ISPE (International Society of Pharmaceutical Engineering) and has been very closely involved in ISPE's cooperation with industry and regulators, especially on the science- and risk based approach and the Quality by Design (QbD) paradigm of pharmaceutical R&D and manufacturing. He is on the Steering Committee of ISPE's Community of Practice for Commissioning and Qualification.