Introduction to C&GT GMP

University Assigned Professor Module: Prof. A Spyridonidis

 

The students will accept a best practice approach to manufacture C&GTs utilizing instructions comply with cGMP guidelines. They will cover all logistics and practical aspects of GMP production.

Introduction to cell and gene therapies

Basic principles of GMP Part 1

Basic principles of GMP Part 2

Elements of a QA System

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Risk Analysis – ICH Q9 and FMEA

The Role of the QP

POCare Manufacturing

Case study