> PRACTICAL MODULE 1. MANUFACTURING PROCESS OF AN INVESTIGATIONAL CELL THERAPY MEDICINAL PRODUCT

This module is compulsory for students registered on the Master Degree in Manufacturing of Advanced Therapy Medicinal Products, specialisation as Manufacturing Manager or as Qualified Person.

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 AUTHORIZED MANUFACTURER

This module is compulsory for students registered on the Expert Degree in Quality Assurance for Manufacturing of Advanced Therapy Medicinal Products and for those registered on the Master Degree in Manufacturing of Advanced Therapy Medicinal Products, specialisation as Qualified Person.

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 authorized manufacturer by means of a practical simulation

> PRACTICAL MODULE 3. PHARMACEUTICAL QUALITY SYSTEM

This module is compulsory for students registered on the Master Degree in Manufacturing of Advanced Therapy Medicinal Products, specialisation as Quality Control Manager or as Qualified Person and for those registered on the Expert Degree in Quality Assurance for Manufacturing of Advanced Therapy Medicinal Products

The main objectives of this module are to learn how…:

  • To manage the pharmaceutical quality system
  • To design, plan, implement, maintain and improve a system which shall allow consistent delivery of products with appropriate quality attributes


> PRACTICAL MODULE 4. QUALITY CONTROL, ENVIRONMENTAL CONTROL, QUALIFICATION AND VALIDATION OF PREMISES AND EQUIPMENT

This module is compulsory for students registered on the Master Degree in Manufacturing of Advanced Therapy Medicinal Products, specialisation as Quality Control Manager or as Qualified Person.

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