EuroGentest, Agence de la biomédecine, Paris
2013-02-07
Meet experienced people in this field, learn about regulatory requirements (ISO 15189) or how to design a proper validation plan for new molecular genetic tests. Genetic tests must be validated before diagnostic use to ensure that they perform according to the laboratory's requirements, and test validation is a formal requirement of many accreditation standards including ISO 15189. In this workshop, we will examine the validation requirements of ISO 15189 and address practical ways of meeting them in your laboratory. 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
For who?The target audience for this workshop are lab directors, lab technicians, lab scientists and quality coordinators.
Focus is on clinical molecular genetics laboratories. The workshops are in English. The number of participants is limited to 30.
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