Charles Burt

Company: Abeona Therapeutics

Job title: Sr Quality Manager

Bio:

Experienced Quality professional in Cell and Gene Therapy, Medical Devices, and IVDR. Recently helped lead a team through a BLA submission and approval for ZevaSkyn. Currently responsible for all supplier and material management activities at Abeona Therapeutics.

Seminars:

Owning the Risk Managing Raw Material Qualification when Suppliers Fall Short 1:45 pm

Understanding the level of due diligence required when using research-use-only or poorly documented reagents in clinical and commercial manufacturing Navigating practical strategies for tracing raw material quality and risk down to secondary and tertiary component levels when suppliers provide limited data Developing internal qualification frameworks and risk assessments to ensure regulatory readiness, despite inconsistent or…Read more

day: Conference Day One