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.

Welcome and syllabus

Introduction to cell and gene therapies (C&GT)

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) Q8-Q12

Technologies for C&GT/ATMP Manufacturing

Challenges οf C&GT/ATMP Manufacturing

POCare Manufacturing

Elements of the Quality Management System (QMS) and QP role

Case study