Institute for Biocomputation and Physics of Complex Systems of the University of Zaragoza

  • 1. State of art and panoramic view of the most significant aspects of the quality control (QC) and surrounding regulatory experimentation and biotechnology research. 
  • 2. Concepts and definitions. Goals. Importance in an organization.
  • 3. History. CC leaders. Integral DC system. ISO. Standardization. CC for Biotechnology.
  • 4. Matters arising from the application of CC in biotechnology. OMG. Bioethics.
  • 5. Major agencies and regulations.
  • 6. National and European Patents. Invention, know-how, patents, others. Tour online.
  • 7. Biological Products and regulation. Clinical Trials. Types and Stages.
  • 8. Standard Operating Procedures. Definition and development of a PNT (collaborative practical work in class, based on a real example of laboratory).
  • 9.Validación. Definition. Reasons to validate. Validation parameters. Stages of validation. ELISA validation.
  • 10. Seminars invited.