Line Lundsberg-Nielsen

  PhotoLine Lundsberg-Nielsen is Global Technology Partner in GMP & Regulatory at NNE. For the last 20 years, she has been working in the pharmaceutical and biotech Industry, both in development and manufacturing. Her background is physics and she has a PhD in NIR spectroscopy. Line’s main consulting areas are Science & Risk based approaches, QbD, PAT, Control Strategy and a lifecycle approach to Process Validation. She has been involved in developing and getting approval of products fully based on QbD, Design Space applications, automated PAT controls and with real time release testing. Line has been a member of ISPE for 15+ years and has served many roles. She is currently member of the global PAT & LCS CoP, past chair of the PQLI Control Strategy team, has co-authored ISPE’s GPG on QbD (PQLI) and Process Validation as well as being an ISPE instructor.