Introductory CMC Analytical Studies and Lab Quality Practices
About the course
This course will provide attendees with a concise but comprehensive overview of all relevant regulatory; technical and quality elements necessary to assure successful design; implementation and documentation of the required CMC analytical and stability studies for biotechnology products; including biosimilar products. Key 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.
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