Line Lundsberg-Nielsen

NNE
Managing Consultant, Compliance Consulting
Line is a physicist and holds a Ph.D. in PAT. Her background is pharmaceutical manufacturing and development, and she is passionate about the Control Strategy.
She works as a Managing Consultant at NNE providing services based on science & risk principles in the areas of QbD, PAT, Control Strategy, Real Time Release Testing, Process Validation, Science and Risk based Qualification and Technology Transfer.
Line has been a member of ISPE for 20 years and has served many roles. She is currently the chair of the global PAT & LCS CoP, a member of the Pharma 4.0 CoP Advisory Board, the Holistic Digital Enablement team as well as a co-author of several ISPE guidelines incl the APQ PPPQMS and the Pharma 4.0 Baseline guide in progress.

Related Articles

The Power of Fleet Management in Distributed Manufacturing
Technical
The Power of Fleet Management in Distributed Manufacturing
The pharmaceutical industry faces significant challenges in rapidly expanding production capacity to meet the needs of patients. Traditional centralized manufacturing models are increasingly seen as inflexible and slow to adapt to the dynamic demands of modern healthcare. This article proposes a regulatory framework for distributed manufacturing using the concept of fleet management to address...