Stream: Quality Control, Analytics & Product Release
Potency is one of the most challenging quality attributes to define for a living product. Learn potency
requirements across the cell and gene therapy product lifecycle and the potency assurance strategies expected by regulatory authorities.
Learning Objectives:
- Explain the regulatory basis and scientific challenge of potency measurement for advanced therapies
- Map potency requirements across the product lifecycle from early phase to licensure
- Construct a potency assurance strategy supported by CGT case studies
Modules:
- Introduction to Potency Assay
- Potency Requirements Throughout the Product Lifecycle
- Potency Assurance for CGTs & Case Studies
EST. COMPLETION 60 MIN - E-Learning format