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What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to do with each other?
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.
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.
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