Line Lundsberg-Nielsen runs her own consultancy business and works as a Consultant for NNE, supporting clients in developing and implementing manu-facturing processes for pharmaceutical products. She has spent more than 20 years in the pharmaceutical industry. She holds a PhD in process analytical technology (PAT), and her work focuses on science- and risk-based approaches to QbD, PAT, control strategy, process validation, qualification, technology transfer, and Pharma 4.0™. Line has been an ISPE member since 2001. She is currently the Chair of the Global PAT and Lifecycle Control Strategy Com-munity of Practice (CoP) Steering Committee, serves on the advisory board of the Pharma 4.0™ SIG, and is a member of the Validation 4.0 subgroup.