Introductory CMC Analytical Studies and Lab Quality Practices

Online Course • Informa Connect

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.

Provider

Informa Connect

Informa Connect is the world’s leading facilitator of knowledge sharing and business connections. The Informa Connect portfolio provides digital content, memorable face to face experiences, networking, and professional development and learning. Operating in key industry verticals, including finance, life sciences, and technology, we provide the highest-quality content and thought leadership alongside platforms for connecting and collaborating, giving our customers real advantage.