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Uncertainty of Measurement and Method Validation In Accordance With ISO 17025

 

  

Program Duration

:

5 Days

Program Date 1

:

22-26 April, 2012

Program Location

:

Cairo, Egypt

Program Fees

:

US$ 3200/Per Person

 

 

PROGRAM INTRODUCTION:

 

Statistical tools play an important role in GLP to calculate the Uncertainty Measurement. This program will focus on the latest techniques and standards developed to measure the uncertainty of the data.

 

The Guideline for Uncertainty Measurement (GUM) will be introduced in a simple way. Every effort is made in this seminar to eliminate unnecessary complications, to apply the GUM at its simplest level and to take away apparent mystery. Participants who have never drawn up uncertainty budgets before usually develop the required skill well before the end of the seminar. Others who seek explanations of GUM complexities obtain clarifications expressed in simple terms. Measurement uncertainty problems are solved by brainstorming methods so as to generate interaction by all participants. The seminar will use the Statistical Process Control (SPC) module as a tool to validate the uncertainty measurement. It covers control charts and their applicability to uncertainty before covering a step-by-step process of calculating uncertainty for a typical application. Methods of reporting uncertainty, the uncertainty budget and applicable standards and guidelines for expressing measurement uncertainty are covered in some detail. Successful completion of this seminar will enable participants to understand, evaluate and express measurement uncertainty.

Laboratories have a professional obligation to provide accurate and reliable analytical results to customers. The Laboratory should justify the customer’s trust by providing the correct answer to the analytical part of the problem, in other words, results that have demonstrable ‘fitness for purpose’. Analytical method validation is one of the measure universally recognized by laboratory as a necessity for a comprehensive system of quality assurance.

Method validation is the process that provides evidence that a given analytical method, when correctly applied, produces results that are fit for purpose. No matter how well a method performs elsewhere, analysts need to confirm that the method is valid when applied in their laboratory. There is now a much greater emphasis on method validation in the ISO/IEC 17025 accreditation standard. Through a number of workshops within this seminar, delegates build a validation protocol for a method of their choice.

The seminar will introduce the principles of evaluating uncertainty and the tools for identifying uncertainties and using validation data. The seminar will take participants through the process of evaluating uncertainty. Completion of this seminar should provide sufficient training to enable analysts to carry out an uncertainty evaluation for their own laboratory methods.


 

PROGRAM OBJECTIVES:

Upon the successful completion of the seminar, participants will be able to:-

  • Enable scientists/technicians to understand the principles of uncertainty of measurement

  • Know the difference between errors and uncertainties and be familiar with the measures of central tendency & measures of the spread of measurements

  • Learn the various types of hypothesis testing and the concept of ANOVA

  • Introduce the basic principles of correlation and regression

  • Enable them to draw up an uncertainty budget

  • Understand the process of method validation as prescribed by ISO 17025

  • Enable them to draw up a method validation document according to ISO 17025

  • Learn how to set validation criteria that will satisfy the needs of customers

  • Recognize the method of validation by considering the proof of the performance of a method and/or assuring the quality of a measurement according to ISO 17025

  • Perform maintenance of validation by means of analysis of QC samples & CRMs, reproducibility studies and customer management

  • Demonstrate the process of writing a method validation document by presenting some case studies and practical exercises to enhance knowledge and understanding of the subject

WHO SHOULD ATTEND?

This seminar is aimed at laboratory managers of test laboratories and scientists doing measurements in test laboratories.

 

PROGRAM OUTLINES:


 

  • Principles of uncertainty of measurement

  • Errors and uncertainties

  • Measures of central tendency & measures of the spread of measurements

  • Various types of hypothesis testing and the concept of ANOVA

  • The basic principles of correlation and regression

  • Uncertainty budgets

  • Method validation as prescribed by ISO 17025

  • Validation criteria and methods

  • Maintenance of validation

  • QC samples & CRMs,

  • reproducibility studies and

  • customer management

  • Writing a method validation documents