Moelgaard Consulting Information

Moelgaard Consulting is specialised within pharmaceutical manufacturing, technology and compliance. Gert Moelgaard has more than 30 years experience in the pharmaceutial industry, mainly from Novo Nordisk, NNE Pharmaplan and Vetter Pharma Fertigung. He is very actively engaged in the pharmaceutical industry and has been involved in many conferences, guidelines and committees within pharmaceutical manufacturing and compliance in ISPE, PDA and ECA (European Compliance Academy). Gert Moelgaard is currently an active member of ISPE's Facility of the Future initiative and has been the co-leader of ISPE's European conference tracks on Facilities of the Future for several years with an active involvement in new pharmaceutical manufacturing technologies and their practical application. Besides, Gert Moelgaard has been actively involved in the new process validation and qualification guidelines from FDA and EMA, including the new European Annex 15 on Qualification and Validation. He was engaged in FDA's internal training for investigators in the FDA Process Validation Guidance from 2010 to 2012 and has been training both companies and regulatory agencies on the practical application of the new validation approaches. Finally Gert Moelgaard is known from many articles, keynote speeches and other conference presentations for several years, with an outlook on the pharmaceutical manufacturing trends and the regulatory challenges and opportunities within new technologies and the practical application of the new GMP principles called the Science- and Risk-based approach.