Analytical Testing for Biopharmaceuticals (2 days)
Introduces analytical technologies used from raw material qualification through final product release. Participants gain exposure to cell-based assays, ligand-binding assays, analytical chromatography, electrophoresis, spectroscopy, and mass spectrometry while learning the quality and compliance requirements that govern testing laboratories.
Quality and Compliance (2 days)
Examines the quality systems that underpin successful biomanufacturing organizations. Participants learn quality assurance principles, deviation management, audit readiness, compliance programs, and the critical role of quality culture in regulated environments.
Introduction to Validation (1.5 days)
Introduces validation strategies used to ensure manufacturing systems operate reliably and consistently. Topics include validation lifecycle concepts, regulatory requirements, equipment qualification, environmental monitoring, and applied validation exercises.