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PRIMA LAB ACADEMY
P5-A6 · Workshop 6 of 8 in the pathway
No session scheduled

New lots and reagent vigilance

2 afternoons 12 h
Workshop objectives

To enable biologists to organise the receipt, evaluation, acceptance, release into service and monitoring of new lots, then to manage and document incidents involving reagents and in vitro diagnostic devices.

Evaluate, accept, monitor and secure critical changes.

  • criticality analysis
  • designing a lot comparison
  • interpretation of bias and clinical concordance
  • documented biological decision
  • enhanced monitoring after a change
  • assessment of patient impact
  • withdrawal and reporting
  • traceability through to closure
Programme to come

The detailed programme for this workshop has not been published yet.

This programme is announced: its detailed content will be published shortly.

Prerequisites

know how an analytical system generally operates; understand the concepts of calibration and quality control; know the principles of analytical validation; master the basic concepts of bias and precision; be expected to supervise the introduction of new lots.

Intended audience
  • clinical biology residents
  • pharmacist biologists
  • medical doctor biologists
  • medical biologists
  • biologists responsible for a bench
  • biologists supervising reagents, calibrators and controls
  • quality managers with biological responsibility
12 to 20 participants per session
Assessment and validation Training certificate

This programme strengthens skills and employability; it is not an automatic promise of recruitment.

The hands-on workshops of PRIMA Learn. Practise. Excel.

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100 000 F 100 000 F student rate