COURSE OVERVIEW:

The meaning of this course lies in the transition from qualitative laboratory performance to quantified scientific certainty through rigorous mathematical modeling. In a regulated chemical laboratory, the validity of an analytical result is inseparable from the confidence interval that surrounds it. This program provides the advanced statistical and chemical expertise required to prove that an analytical method is fit for its intended purpose and that the reported results are supported by a defensible estimation of measurement uncertainty.

The scope of the training addresses the comprehensive lifecycle of method validation, including the determination of selectivity, linearity, accuracy, and precision. It covers the complex application of the "GUM" (Guide to the Expression of Uncertainty in Measurement) approach specifically for chemical matrices, where factors such as sample preparation, recovery, and glassware tolerances contribute significantly to the total error budget. Participants will explore how to harmonize validation data with the ISO 17025 requirement for reporting measurement uncertainty in a transparent and standardized manner.

The coverage includes detailed instruction on the use of ANOVA for precision studies, the calculation of the Limit of Detection (LOD) and Limit of Quantitation (LOQ), and the evaluation of ruggedness and robustness. The course emphasizes the practical use of "Uncertainty Budgets" and the interpretation of "Coverage Factors" to determine the expanded uncertainty. By mastering these validation and calculation protocols, participants will be able to ensure that their chemical testing results are robust, legally defensible, and internationally comparable.

COURSE OBJECTIVES:

After completion of this course, the participants will be able to:

• Define the core requirements for method validation according to ISO 17025.
• Distinguish between method validation and method verification.
• Calculate the Limit of Detection (LOD) and Limit of Quantitation (LOQ).
• Perform a full linearity study using regression analysis and residuals.
• Evaluate method precision through Repeatability and Reproducibility (R&R).
• Determine analytical "Recovery" and "Bias" using certified reference materials.
• Construct a comprehensive "Uncertainty Budget" for a chemical test.
• Identify and quantify Type A and Type B uncertainty components.
• Use the "Root Sum of Squares" method to combine uncertainty sources.
• Apply "Coverage Factors" to report expanded uncertainty at 95%.
• Conduct "Ruggedness" testing to identify critical process variables.
• Document validation reports that satisfy accreditation body assessments.

TARGET AUDIENCE:

This course is intended for Analytical Chemists, Quality Assurance Officers, Laboratory Technical Managers, and Scientists involved in method development and validation.

TRAINING COURSE METHODOLOGY:

A highly interactive combination of lectures, discussion sessions, and case studies will be employed to maximize the transfer of information, knowledge, and experience. The course will be intensive, practical, and highly interactive. The sessions will start by raising the most relevant questions and motivating everybody to find the right answers. The attendants will also be encouraged to raise more of their questions and to share in developing the right answers using their analysis and experience. There will also be some indoor experiential activities to enhance the learning experience. Course material will be provided in PowerPoint, with necessary animations, learning videos, and general discussions.

The course participants shall be evaluated before, during, and at the end of the course.

COURSE CERTIFICATE:

National Consultant Centre for Training LLC (NCC) will issue an Attendance Certificate to all participants completing a minimum of 80% of the total attendance time requirement.