QC for CGT/Equipment

University Assigned Professor Module: Ass. Prof. Stathopoulos, Stamatopoulou

 

The students will gain knowledge about assay availabilities in the industry as well as best practices on how to create a QC plan and choose the right assay for a specific therapy.

GMP from Phase 1 to Phase 3

Computerised System Validation

“Contamination Control Strategies”

“Critical Quality Attributes (CQA)

Critical Process Parameters (CPP)”

“Qualification and validation of analytical and bioanalytical methods”

Chain of custody

GDP

Stability

Personnel training

Risk Analysis case study