> 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):