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...
Digital Transformation at the 2023 Annual Meeting & Expo
iSpeak Blog
Digital Transformation at the 2023 Annual Meeting & Expo

Digital Transformation (DT) is impacting every aspect of our personal and professional lives, so it was no surprise that nearly one-third of all presentation proposals for this year’s ISPE Annual Meeting involved DT topics. It is a testament to the breadth of DT that there are three ISPE Communities of Practice (CoPs) operating in this space, each of whom had submitted high-quality...

The History & Future of Validation
Features
The History & Future of Validation

Across every industry today, digitalization is driving the use and value of data to disrupt traditional business models and ways of working. In pharmaceuticals, the promises of Industry 4.0 are expected, and needed, to finally modernize the legacy approaches that have evolved since the 1970s. Validation is an obvious target for digital disruption because of the inefficient, document-heavy...