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Introduction to Method Validation

This course is designed for participants desiring to understand the terminology, principles, and criteria for validating methods. Participants will also learn the historical background and importance of method validation, differences between quality control and quality assurance, and their unique impacts on method validation. The differences between method validation and method verification will be highlighted and explained as these terms relate to the correct implementation of ISO/IEC 17025, ISO 17034, and, in some instances, ISO/IEC 17043. The emphasis behind this revision of the course is the focus of EURACHEM’s The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics. Participants will learn key documentary requirements and be introduced to the mathematical and statistical computations using a provided Microsoft Excel workbook template to validate chemical and microbiological methods.

Prerequisites

Required: This is a mathematics and statistics-based course. Familiarity with basic MATH and STATISTICAL functions and understanding the order of math operations (PEMDAS).

Desired: Participants should have bench experience applying analytical methods in a chemistry and/or microbiology laboratory environment and familiar with the requirements for method validation per the appropriate quality system standards employed in their laboratories, e.g., ISO/IEC 17025, ISO 17034, or ISO/IEC 17043. To evaluate and validate modified national or international methods or laboratory-developed methods, participants are encouraged to participate in the following courses:

Equipment Needed

-Virtual Delivery

Laptop (PC or Pac) / MS Excel or equivalent (can use Google Sheets)

-In-Person (on Location)

Laptop (PC or Pac) / MS Excel or equivalent (can use Google Sheets)

Target Attendees

This workshop is intended for participants who desire to understand the key terminology and components required to validate a modified standard or laboratory-developed method.

Organizational Level

-Directors, Managers, and Supervisors

GOALS:  Understand the approval requirements for validating methods, fitness-for-use, and verification prior to introducing the methods into production

-R&D and Production Scientists, and Laboratory Technicians

GOALS:  Explain the different attributes and requirements to validate a method

Learning Outcomes

After the successful completion of the workshop, participants will be able to, with a provided Excel workbook and instructor/class chosen measurement method:

  1. Determine “Fit for Intended Use” of a test method
  2. Recognize the components of a method validation and write a validation plan
  3. Establish the required performance, acceptance criteria of the method
  4. Describe the difference between method validation and method verification
  5. Determine the performance characteristics that should be verified or validated
  6. Establish criteria for experimental design and acceptance
  7. Using the supplied Excel ™ workbook and data set, estimate values for validation performance characteristics
  8. Discuss how method validation utilizes target measurement uncertainty and decision limits, and decision rules with defined probabilities, and
  9. Write a validation report

CEUs Awarded

0.7 CEUs Awarded* (7 active training hours, 8 hours total)

* A2LA WorkPlace Training is accredited by the International Association for Continuing Education and Training (IACET) and is authorized to issue the IACET CEU.

Presentation Style

Lectures, discussions, and classroom exercises.

Reference

JCGM 100:2008 (Free Download) – Evaluation of measurement data – Guide to the expression of uncertainty in measurement (GUM)

NIST Tech Note 1297 (Free Download) – Guidelines for Evaluating and Expressing the Uncertainty of NIST Measurement Results

JCGM 200:2012 (Free Download) – International Vocabulary of Metrology – Basic and general concepts and associated terms (VIM)

ILAC G17:01/2021 (Free Download) – ILAC Guidelines for Measurement Uncertainty in Testing

Eurachem Guide 2025 – The Fitness for Purpose of Analytical Methods A Laboratory Guide to Method Validation and Related Topics

ISO/IEC 17025:2017 (Optional) – Conformity Assessment – General requirements for the competence of testing and calibration laboratories