Line Lundsberg-Nielsen is Global Technology Partner at NNE Pharmaplan. For the last 20 years, she has been working in the pharmaceutical Industry, both in pharmaceutical development and product manufacturing. Her background is physics and she has a PhD in NIR spectroscopy. Line’s main consulting areas are QbD, PAT 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 for each CQA. Line has been a member of ISPE for 15 years and has served many roles. She was member of the ISPE PQLI Technical Committee, past chair of the PQLI Control Strategy team and has recently been one of the authors of ISPE’s Process Validation Course that she also teaches.