Event - BASIC Workshop - Validation of diagnostic tests in clinical molecular genetics (WP1.8 - WP1.7)

What

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 number of participants is limited to 25.

The workshops are in English.

Registration

It is highly recommended to bring the ISO 15189 accreditation standard for medical laboratories with you.
In case you do not have ISO 15189 you can order a pdf version in combination with your registration for this workshop.

Registration fee for this workshop is 425 euro per person
Registration fee for industrial partners is 525 euro per person

Registration fee + ISO 15189 standard in pdf is 550 euro per person
Registration fee + ISO 15189 standard in pdf is 650 euro per person for industrial partners

The registration fee covers documentation, dinner on Friday evening, plus two lunches and morning and afternoon refreshments.
Travel and hotel are at the expense of your laboratory.

Registration closes September 28, 2009 (but note that the number of places are limited).
Follow this link to have access to the registration form.

You are free to choose an accommodation in a different hotel. In that case you have to book the rooms yourself:
- Hotel Albergo delle Drapperie http://www.albergodrapperie.com/
- Hotel Paradise http://www.hotelparadisebologna.it/
- Collegio Erasmus http://www.ceur.it/collegio-erasmus/
- B&B Chez Vevé http://www.chezvevecamere.it/
- B&B Piazzetta Morandi http://www.piazzettamorandi.com/
- B&B Amarcord http://www.amarcordbologna.it/
- B&B Cosy house (No website) Via della Grada 2 - 40122 Bologna, Tel +39 051 554207
- B&B Le Mura (No website) Via San Donato, 4 - 40127 Bologna, Tel +39 051 250351
- B&B C'era una volta il Salento (No website) Via Orfeo 12 - Bologna, Tel +39 051 778663

Cancellation policy

For cancellation within 6 weeks of the workshop, 50% of the registration fee is due to cover our costs.
For cancellation within 3 weeks or no-show, registration will be billed in full.

If you are unable to attend you may nominate a replacement participant and transfer the registration any time before the first day of the course.