How to validate diagnostic tests in clinical molecular genetics?

Meet experienced people in this field, learn about regulatory requirements (ISO 15189) and how to design a proper validation plan for new molecular genetic tests.

After the workshop, the participants will be able to...

• Explain the aims and the importance of validation.
• Describe the regulatory requirements and recommendations concerning validation and where to find them
• Write a validation plan:
  • Distinguish between validation and verification
  • Develop a checklist of parameters to be addressed
  • Define key components of validation plan and apply these parameters to a simple example
  • Determine which type of validation is relevant for which test
  • Design experiments to validate a particular test
• Explain the content, the criteria and the required data for a comprehensive validation report
• Design and implement appropriate internal quality control to follow-up test performance

Registration and more information.