10:00 to 11:00 CEST
Agenda
- Introduction and definition about impurities
- ICH Guidelines and other guidelines derived from them
- USP approach to impurities and nitrosamines testing
- PAI (Pharmaceutical Analytical Impurities) complementing USP RS (Reference Standards)
Christian Zeine joined USP in 2019 as Senior Manager in the Scientific Affairs Group for the EMEA region, with a focus on Small Molecules, USP’s General Chapters and Impurities. In his job, he collaborates with scientific experts and stakeholders and is responsible for protecting and growing USP’s scientific reputation in the region and globally. Before joining USP, Christian worked for seventeen years in the field of pharmaceutical reference standards with a focus on impurities, and before that in the IVD (In Vitro Diagnostic) industry. His scientific expertise includes impurity testing, reference standards characterization and adjacent fields.
Christian has published several articles and white papers on topics such as impurities, overview of (certified) reference materials and the use of reference standards in method development and validation. He earned his Ph.D. degree in Organosilicon Chemistry from the University of Muenster, Germany.