Workshop - Diagnostic Validation

Aims

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.

Topics will include:

• terms and definitions
• defining the elements to be validated
• approaches to validating specific tests
• approaches to validating general methods
• determining uncertainty
• writing a validation report
• ongoing (follow-up) validation.

Common misunderstandings regarding validation will be discussed, and case studies and group discussion will be used to illustrate the theoretical aspects and to help you develop practical strategies for your laboratory.

Target group

The participants of this workshop should have a basic knowledge of quality management and ISO 15189 or ISO 17025.
These workshops are of equal value to accredited and non-accredited genetic testing laboratories.
Participants include lab directors, scientists, technicians and quality managers that are involved in the validation in the laboratory.
As the number of participants is limited to 25, we can only accept maximum two people of the same laboratory.

The workshop language is English.

List of workshops

• 8/9-01-2009 Prague
• 26/27-10-2009 Bologna --> registration opens January 2009

Last changed: 2008-12-15