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    Method Validation Training Schedule

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    This document outlines the agenda for a 5-day training on statistical method validation presented by the Zambia National Laboratory Association (ZNLA) in 2019. The training covers topics such as quality control and assurance, method validation requirements, basic statistical tools including distributions, measures of central tendency and spread, hypothesis testing, regression, and measurement uncertainty. Presenters will discuss these topics and participants will complete tests each day to assess learning with a final examination on the last day. The goal is to equip attendees with skills for validating analytical methods using statistical techniques.

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    Method Validation Training Schedule

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    ernest
    22 views3 pages
    This document outlines the agenda for a 5-day training on statistical method validation presented by the Zambia National Laboratory Association (ZNLA) in 2019. The training covers topics such as quality control and assurance, method validation requirements, basic statistical tools including distributions, measures of central tendency and spread, hypothesis testing, regression, and measurement uncertainty. Presenters will discuss these topics and participants will complete tests each day to assess learning with a final examination on the last day. The goal is to equip attendees with skills for validating analytical methods using statistical techniques.

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    Method Validation Training Schedule (2)

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    This document outlines the agenda for a 5-day training on statistical method validation presented by the Zambia National Laboratory Association (ZNLA) in 2019. The training covers topics such as quality control and assurance, method validation requirements, basic statistical tools including distributions, measures of central tendency and spread, hypothesis testing, regression, and measurement uncertainty. Presenters will discuss these topics and participants will complete tests each day to assess learning with a final examination on the last day. The goal is to equip attendees with skills for validating analytical methods using statistical techniques.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    22 views3 pages

    Method Validation Training Schedule

    Uploaded by

    ernest
    This document outlines the agenda for a 5-day training on statistical method validation presented by the Zambia National Laboratory Association (ZNLA) in 2019. The training covers topics such as quality control and assurance, method validation requirements, basic statistical tools including distributions, measures of central tendency and spread, hypothesis testing, regression, and measurement uncertainty. Presenters will discuss these topics and participants will complete tests each day to assess learning with a final examination on the last day. The goal is to equip attendees with skills for validating analytical methods using statistical techniques.

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    of 3

    ZAMBIA NATIONAL LABORATORY ASSOCIATION (ZNLA) 2019

    STATISTICAL METHOD VALIDATION

    Day Topic of discussion/contents Presenter (s)

    1. a) Introduction/Course Expectations Mr. R Kamekela


    b) Introduction To Validation Of Methods
    Importance of analyses
    Quality Control and Quality Assurance
    Quality Control
    Quality Assurance
    The Need for a quality system
    Quality systems
    Why Validation?
    c) Introduction To Terminology
    Validation
    Testing
    Calibration
    Verification
    Qualification
    Method Validation
    Fitness for Purpose
    The need for a statistical tool in validation of methods
    Control Charts
    Flowcharts
    d) Test 1

    2. Basic Statistical Tools For Validation Of Methods Mr. H Manda


    Sampling
    Tabulation and Graphical Representation
    Frequency Distribution
    Cumulative Distributions
     Normal Distribution
     Uniform or Rectangular distribution
     Triangular Distribution
     Other distributions
    Descriptive Measures of Location or Central Tendency
     The Arithmetic Mean
     Weighted arithmetic mean
     The Median
     The Mean and Median for Grouped Data
    Measures of Spread
     Variance and Standard Deviation
     Interpretation of the Standard Deviation
     The Normal Distribution and Standard Deviation
     Relative Measure of Spread
    Rejection of a result
     The Q Test
     The Grubbs test for rejection of data
    Test 2
    ZAMBIA NATIONAL LABORATORY ASSOCIATION (ZNLA) 2019

    3. Basic Statistical Tools For Validation Of Methods…Continued Mr. H Manda


    Tests of significance
     The F test
     The t Test
     The paired t Test
     The t Test with multiple samples
     ANOVA the analysis of variance between groups
    Test 3

    4. a) Basic Statistical Tools For Validation Of Methods…Continued


    Mr. H Manda
    Simple Linear Regression and Correlation (Morning Session)
     Bivariate Data
     Regression Analysis
     Scatter Diagrams
     Plotting data for a straight line
     Calculating the Correlation Coefficient and its meaning
    b) Validation Of Analytical Methods Mr. R Kamekela
    Validation (Afternoon session)
    Method Validation
     Precision
     Repeatability Precision
     Intermediate Precision
     Reproducibility
    The Trueness
    Recovery
    Specificity
    Limit of detection LOD
    Limit of quantitation LOQ
    Linearity
    Ruggedness
    Robustness
    c) Getting Started
    What can be validated?
     Laboratories
     Laboratory quality assurance and control
     Instrumentation
     Staff - Motivation
     Staff - Poor performance
     Reagents and their purity
     Sampling
    When should methods be validated?
    Steps in Method Validation
    Test 4
    ZAMBIA NATIONAL LABORATORY ASSOCIATION (ZNLA) 2019

    5. a) Uncertainty Of Measurement Mr. R Kamekela /


     Definition of Measurement Uncertainty Mr. H Manda
     Expression of Measurement Uncertainty
     17025:2017 & 15189:2012 Requirements
     Use in selection of methods
     Use in reporting
     Statistics, Units and Calculations
     Standard deviation
     Transformation of non-normal data
     Harmonisation of scales & units
     Approaches to Estimation of Measurement Uncertainty
     Metrological approach
     Single Within-Laboratory Approach
     Qualitative Results
     Guidance Documents
     Examples in determining uncertainty
     Correct rounding of digits

    b) Examination (3 Hours) 26/07/2019 (13:30 – 16:30hours)

    c) Closure of training (ZNLA Representative)

    Notes:

    08:30 – 10:30 Lecture


    10:30 – 10:50 Tea Break
    10:50 – 12:50 Lecture
    12:50 – 13:30 Lunch Break
    13:30 – 15:30 Lecture
    15:50 – 16:50 Test (Day 5 will not have a test but exam)

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