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Course Overview (from website):

This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical, and quality elements necessary to assure successful planning and documentation of the required CMC analytical and stability studies for biological products. Key data deliverables from each phase of development will be illustrated. Current ‘hot-button’ CMC analytical and stability issues will be presented, and strategies for preventing (or remediating) gaps will be presented, based on real-world experiences of Dr. Nadine Ritter supporting hundreds of biological products over more than 25 years.


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