CMC regulatory compliance deficiencies have resulted in clinical holds and delays in market approval. Additionally, CMC regulatory shortfalls in marketed products have also resulted in FDA Warning Letters and product recalls. Insights and practical suggestions to develop and manage CMC regulatory compliance for biopharmaceuticals and biologics are presented in this class. This three-day course will also present a strategy to obtain a cost-effective, risk-managed CMC compliance strategy especially useful for all stages of clinical development, and for those biopharmaceutical and biologic products already on the market. This course also includes a discussion on preparing the CMC sections for a market application dossier using the Common Technical Document (CTD)-formatted Modules 2.3 and 3 for biopharmaceuticals and biologics.