Assessing the Risk of Interaction Between Extractables and Leachable and Ther... - Seguridad Mania.com - España y América Latina

FULL TITLE: Assessing the Risk of Interaction Between Extractables and Leachable and Therapeutic Proteins Presented by Andrew Teasdale, Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca Chair of AstraZeneca impurities advisory group. Responsible for the development and oversight of policy relating to all impurity categories, including impurity qualification / genotoxic impurities / metals and extractables & leachables. Expert within the field of Genotoxic Impurities. Editor of the first book specifically focused on the subject matter : Genotoxic Impurities: Strategies for Identification and Control. Current activities include leading a cross industry group in the development of an addendum table to ICH M7, including specific limits for genotoxic reagents (analogous to that in place in ICH Q3C for solvents). Inventor of the purge factor calculation concept used in the risk assessment of genotoxic impurities. Currently the chair of the Extractables and leachables safety information exchange (ELSIE) materials group. Also chair of the Joint Pharmaceutical Analytical Group (JPAG). Expertise also within the within quality assurance and pharmaceutical analysis field. Extensive project management experience both internally and in relation to cross industry collaborations. Specialties: Evaluation and risk assessment of genotoxic impurities / metals and extractables and leachables. Analytical chemistry >15yrs experience as an analytical chemist. Chairman of the Joint Pharmaceutical Analytical Group (JPAG).