|
Career:
Torben Elhauge holds a master of analytical chemistry from The Technical University of Denmark and has been employed in the pharmaceutical area since 1994.
He has been employeed in Nycomed A/S, Statens Serum Institut, The Danish Medicines Agency, Life Cycle Pharma A/S, LiPlasome Pharma A/S and Egalet Denmark.
Areas of Employment
- Development, validation, transfer and control of analytical methods
- Systems to qualify and maintain the equipment
- Trained internal auditor with in EN17025
- Development and maintenance of quality systems
- Development of monographs in expert group 10D in the European Pharmacopeia
- Validation of methods in your own lab using relevant equipment, personnel etc.
- Quality assessment of registration files and control of medicinal products on the market
- Education internally and through pharmacon
- Development and presentation of material in connection with Due Diligence
- Development of access databases for quality systems etc
Torben have experience with performing the following registration material to both EU and FDA:
- Analytical methods
- Validation protocols and reports
- Specifications
- Stability protocols and reports
- Comparative dissolution
- Pharmaceutical and technical development reports
- Have delivered registration material to the FDA leading to approval
|
