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FEB 24, 2021 8:00 AM PST

Best Practices for Lot Changes in Quality Control or Reagents

C.E. Credits: P.A.C.E. CE Florida CE
Speakers
  • Scientific Fellow, Bio-Rad Laboratories
    Biography

      Mr. Yundt-Pacheco performs research in quality control and patient risk issues in the Informatics Discovery Group at Bio-Rad. John has had the opportunity to work with laboratories around the world, developing practical real time, inter-laboratory quality control and proficiency testing systems. As an innovator, has developed numerous ideas leading to 37 laboratory related invention patents around the globe.



      John holds a Master's degree in Computer Science from University of Texas at Dallas with a focus on Intelligent Systems and has a Post Master's Certificate in Sequence Analysis and Genomics, and is a degree candidate for a Master's degree in Biotechnology at Johns Hopkins University. In addition to authoring articles and papers on QC design, he is a popular speaker on laboratory QC and QA topics at international conferences.

    • Scientific and Professional Affairs Manager, Bio-Rad Laboratories
      Biography

        Mr. Nico Vandepoele serves as Scientific and Professional Affairs manager for the Bio-Rad Laboratories Quality Control Division. He works to promote an understanding of laboratory regulations and best practices as they pertain to QC and EQA/PT programs. Nico is a well-recognized speaker and presents trainings, workshops and lectures at symposia around the world and volunteers on several CLSI committees.



        Nico studied in Bruges Belgium in the Higher Technical Institute and graduated in 1995 as a Bachelor in Clinical Chemistry with a dual degree in Information Technologies and Chemistry. He worked in a clinical lab for and then for a Biotech company as head of the research lab before starting at Bio-Rad as Field Application Specialist. In 2010, Nico became product manager for the Quality Systems Division in Irvine, California where he managed the Unity and EQAS informatics programs.


      Abstract

      Starting a new quality control or reagent lot is a critical point in the workflow of a lab.  Standard clinical laboratory practices can vary during this process and these changes have the potential to adversely affect patient results and lab operations. To ensure your laboratory produces consistent patient results, this webinar will present the most recent developments and best practices to perform quality control and reagent cross-over studies.

      Learning Objectives:

      1. Identify how to establish the new mean and standard deviation (SD)

      2. Describe the new simplified CLSI C24 (A4) guidance to perform cross-over studies

      3. Explain how to use QC and patient specimens to verify the integrity of a new reagent lot


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