An NSF International Company Dr Line Lundsberg
Consultant
BSc, MSc, PhD, D MMPI
- [email protected]
- +44(0)1751 432999
Line is PhD in NIR spectroscopy by the University of Copenhagen and MSc in Physics from University of Copenhagen, The Niels Bohr Institute
Line has 15 years’ experience in the pharmaceutical industry, first in Quality Control, later Quality Assurance mostly from Manufacturing of APIs, oral solid dosage forms and sterile products. Line has worked in the field of Process Analytical Technology and Quality by Design. She has been a member of development teams involved in submitting NIR methods for Identification, Assay, Content Uniformity and Water Content. Which have been approved by EU regulators.
Line is Chair of the ISPE PQLI Control Strategy team, Member of the ISPE PQLI Technical Committee and member of the ISPE PQLI Illustrative Example team. She is also Co-author of a Good Practice Guide on how to implement Quality by Design (in progress)
Line has an impressive industry background that inludes : Past Chair and founder of the ISPE Process Analytical Technology Community of Practice, UK and Ireland; Past founder of the ISPE Process Analytical Technology Community of Practice, Nordic Region; Past Member of the ISPE Process Analytical Technology Steering Committee, Global Community of Practice; Past Membership Secretary of the ASTM E55 Executive committee on Manufacturing of Pharmaceutical Products. Line was originally appointed by the FDA as a member of the Executive committee and to help start the E55 committee
Line got the ASTM Award 2006, acknowledging her ongoing successful effort in getting the EMA PAT Team involved in ASTM E55, she has also spoken at the IFPAC Conferences for the last 8 years – QbD conference organised jointly with the FDA - and has delivered many training courses in QbD, PAT, Science and Risk-based approach to Verification
Line is Member of the International Society for Pharmaceutical Engineering (ISPE) and Member of the ASTM Committee E55 on Manufacture of Pharmaceutical Products, an International Standard Organisation on Pharmaceutical Manufacturing Exec Committee.
