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Course Description

This 5-day training course provides an in-depth and practical understanding of method validation and measurement uncertainty in accordance with ISO/IEC 17025, ISO 5725, EURACHEM, and relevant analytical and testing standards. The course enables participants to design, execute, evaluate, and document method validation studies and to calculate, express, and apply measurement uncertainty in laboratory testing and calibration activities.

Course Objectives

Upon completion of this course, participants will be able to:

  • Interpret international standards related to method validation and measurement uncertainty.
  • Design and conduct method validation and verification studies.
  • Apply statistical tools for evaluating validation data.
  • Identify and quantify sources of measurement uncertainty.
  • Calculate, express, and report measurement uncertainty correctly.
  • Prepare validation and uncertainty documentation for audits and accreditation.
  • Confidently respond to ISO/IEC 17025 auditor expectations.

Who Should Attend?

This course is designed for laboratory managers, quality managers, technical managers, analysts, technicians, engineers, calibration specialists, auditors, and professionals involved in testing, calibration, or laboratory accreditation.

Course Agenda

Registration

Welcome & Introduction

Pre-Test

Day 1: Standards, Concepts & Planning

  • Overview of laboratory quality systems
  • ISO/IEC 17025 requirements related to:

          Method validation

          Measurement uncertainty

  • ISO 5725, EURACHEM, ICH and sector-specific guidelines
  • Types of test and calibration methods:

          Standard methods

          Non-standard methods

          Modified methods

          In-house methods

  • Validation vs verification
  • When validation is required
  • Developing a method validation plan
  • Defining performance requirements and acceptance criteria
Day 2: Method Validation Parameters 
  •  Accuracy and trueness
  • Precision:

          Reproducibility

          Intermediate precision 

          Reproducibility

  • Linearity and working range
  • Selectivity and specificity
  • Sensitivity
  • Limit of Detection (LOD) and Limit of Quantification (LOQ)
  • Robustness and ruggedness
  • Stability studies
  • Practical examples of validation parameters
Day 3: Validation Studies, Statistics & Reporting  
  • Designing validation experiments
  • Sampling and data collection strategies
  • Basic statistical tools for validation:
          Mean, standard deviation, CV

          Confidence intervals

          Regression analysis

  • Evaluating validation results against acceptance criteria
  • Handling outliers and abnormal data
  • Dealing with non-conformities
  • Validation report structure and documentation requirements
  • Common audit findings related to method validation
Day 4: Measurement Uncertainty – Principles & Estimation
  • Introduction to measurement uncertainty
  • Definitions and terminology
  • Why uncertainty is required (technical and regulatory reasons)
  • Identifying sources of uncertainty:
          Instrumentation

          Environmental factors

          Reference standards

          Operator influence

          Method performance

  • Type A and Type B uncertainty components
  • Uncertainty budgets
  • Bottom-up vs top-down approaches
  • Practical examples of uncertainty estimation
Day 5: Measurement Uncertainty Application & Audit Readiness
  • Calculating combined and expanded uncertainty
  • Coverage factors and confidence levels
  • Expressing and reporting uncertainty results
  • Measurement uncertainty in calibration vs testing
  • Decision rules and statements of conformity
  • Relationship between validation data and uncertainty
  • ISO/IEC 17025 auditor expectations
  • Common non-conformities related to uncertainty
  • Best practices for maintaining uncertainty calculations
  • Course review and key takeaway

Post Test

End of the Course

Assessment Methodology

All courses conducted by EdTech will begin with a Pre-evaluation and end with a Post-evaluation. The instructor will evaluate the knowledge and skills of the participants according to the feedback given by participants. This will help to recognize the benefits and the level of knowledge gained by participants through the course.

Training Methodology

Facilitated by a highly qualified specialist, who has extensive knowledge and experience; this program will be conducted using extensively interactive methods, encouraging participants to share their own experiences and apply the program material to real-life work situations in order to stimulate group discussions and improve the efficiency of the subject coverage.

Percentages of the total course hour classification are:

  • ​40% Theoretical lectures, Concepts and approach
  • 20% Motivation to develop individual skill and Techniques
  • 20% Case Studies and Practical Exercises
  • 20% Topic General Discussions and interaction

Course Manual

Participants will be provided with comprehensive presentation material as reference manual. This presentation material is a compilation of core valuable information, references, presentation methods and inspiring reading which will be used as a part of the material guide.

Course Certificate

At the completion of the course, all participants who successfully accomplished the required contact hours will receive an EdTech Training Participation Certificate as a testimony to their commitment to professional development and further education.

Why Edtech ?

  • Industry Experienced; Internationally Qualified Trainers
  • Hands-on Practical Sessions & Assignments
  • Intensive Study materials
  • Flexible Schedules
  • Realistic training methodology
  • High-Quality Training in Affordable Course Fees
  • Achievement Certificate, as approved by the Ministry of Education (Abu Dhabi Center for Technical and Vocational Education Training - ACTVET), HABC, AWS, IAOSHE, SHRM, etc.