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Method Validation & Uncertainty of

Measurments

  

Program Duration

:

5 Days

Program Date 1

:

22-26 April, 2012

Program Location

:

Cairo, Egypt

Program Fees

:

US$ 3200/Per Person

 

 

PROGRAM INTRODUCTION:

 

Any measurement is subject to imperfections; some of these are due to random effects, such as short-term fluctuations in temperature, performance of the methods used, humidity and air-pressure or variability in the performance of the measurer. Repeated measurements will show variation because of these random effects. Other imperfections are due to the practical limits to which correction can be made for systematic effects, such as offset of a measuring instrument, drift in its characteristics between calibrations, personal bias in reading an analogue scale or the uncertainty of the value of a reference standard.

Method validation

The performance of the methods is important in ensuring that the results obtained are reliable and fit for purpose. Method validation may be interpreted as being the process of defining an analytical requirement, and confirming that the method under consideration has performance capabilities consistent with what the application requires. Implicit in this is that it will be necessary to evaluate the method’s performance capabilities.

Thus the method should be validated when it is necessary to verify that its performance parameters are adequate for use for a particular analytical problem. For example:

  • New method developed for particular problem;

  • Established method revised to incorporate improvements or extended to a new problem;

  • When quality control indicates an established method is changing with time;

  • Established method used in a different laboratory, or with different analysts or different instrumentation;

  • To demonstrate the equivalence between two methods, e.g. a new method and a standard.

Uncertainty of measurements

Uncertainty is a quantitative indication of the quality of the result. It gives an answer to the question, how well does the result represent the value of the quantity being measured? It allows users of the result to assess its reliability, for example for the purposes of comparison of results from different sources or with reference values.

Confidence in the comparability of results can help to reduce barriers to trade.

Uncertainty is as such an unavoidable part of any measurement, and a proper evaluation of uncertainty is good professional practice and can provide laboratories and customers with valuable information about the quality and reliability of the result.

It is therefore important that laboratory chemists understand and are able to evaluate measurement uncertainties. It is against this background that this course

has been organized aimed at equipping Laboratory staff with necessary skills in method validation and uncertainty of measurement to enable them produce reliable results that are internationally accepted and thus reduce barriers of trade as a result of analytical results.



 

PROGRAM OBJECTIVES:

At the end of the training the participants will be expected to have learnt and understood:

  • Principles of method validation and uncertainty of measurements

  • Requirements of ISO/IEC 17025 with regards to method validation and uncertainty of measurements

  • Basic Statistics; average, standard deviation, variance, coefficient of variance, calculations using excel

  • Performance characteristics of the methods; linearity, specificity, selectivity, LOD, LOQ, Repeatability, Reproducibility

  • Identification of all sources of uncertainties using fishbone diagram

  • Estimation of uncertainty of measurements for all methods

  • Evaluation for methods for “Fitness for purpose”

 

PROGRAM OUTLINES:

  • Introduction

  • Overview of requirements of ISO 17025 on Methods

  • Development

  • Basic Statistics

  • Exercises- Basic Statistics

  • Presentations

  • Discussions

  • Principles of Method validation

  • Determination of Method validation parameters

  • Case study on Method validation

  • Presentations

  • Principles of uncertainty of measurements

  • Sources of uncertainty using fish bone diagram

  • Quantification of uncertainties

  • Quantification of uncertainties

  • Estimation of uncertainty-Example

  • Estimation of uncertainty-Exercise

  • Presentations

  • Discussions & Evaluations