15 mins

Cell Therapy (CAR T) Processing

Test Systems, Test Articles, and Safety Endpoints in GLP Protocols

Deviation – Initiator

Serious Breaches

ICH E8 Section 4 – Drug Development Planning

Regulatory Submissions

The Fundamentals of Quality Management Systems – Pharma

Batch/Product Release

Equipment Maintenance

ICH E8 Section 3 – Designing Quality into Clinical Studies