> PRACTICAL MODULE 1. MANUFACTURING PROCESS OF AN INVESTIGATIONAL CELL THERAPY MEDICINAL PRODUCT
The main objectives of this module are to learn how…:
- To produce an investigational cell therapy medicinal product according to GMP guidelines
- To recognise the differences between cell culture for research and manufacturing of a cell product
- To co-work with quality control for ensuring GMP guidelines
- To generate documentation and control it
- To carry out manufacturing validations
- To enter and exit a GMP facility
- To define manufacturing critical points
- To clean a GMP facility
- To manage material
- To master tissue engineering techniques
> PRACTICAL MODULE 2. SITE MASTER FILE AND HOW TO PASS THE MANDATORY INSPECTIONS TO BECOME AN AUTHORISED MANUFACTURER
The main objectives of this module are to learn how…:
- To prepare a site master file in ATMPs: the site master file must be carried out by the manufacturer and submitted to the regulatory authority
- To successfully pass the mandatory inspections to become an authorised manufacturer by means of a practical simulation
> PRACTICAL MODULE 3. QUALITY CONTROL, ENVIRONMENTAL CONTROL, QUALIFICATION AND VALIDATION OF PREMISES AND EQUIPMENT
The main objectives of this module are to learn how…:
- To control advanced therapy medicinal products according to GMP guidelines
- To culture cells for advanced therapy medicinal products
- To co-work with the manufacturing department to ensure the compliance of GMP Guidelines
- To generate relevant documentation and control it
- To manage related material
- To carry out quality control validations
- To perform culture media and environmental control
- To master basic techniques in microbiology
- To practice endotoxins and mycoplasma test according to European pharmacopoeia
- To carry out sterility and growth promotion test
Find out more about this practical training in the following youtube video (click on the image):
