QC for CGT/Equipment Analytical Methods

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.

Introduction to Analytical Development

Equipment validation and qualification (DQ-PQ)

Contamination Control Strategies

Qualification and validation of analytical and bioanalytical methods

Computerized System Validation

Stability studies – design, performance, reporting and conclusions

Supply Chain for CGTs

Case study (Analytical method qualification)