Introduction to C> GMP
University Assigned Professor Module: Prof. A Spyridonidis
The students will accept a best practice approach to manufacture C>s 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
