Introduction to the Course

Basics of Measurement Uncertainty

•     Definition of measurement and uncertainty
•     Analytical Procedures (Methods) as Processes
•     Error sources and statistical descriptions
•     Accuracy and Trueness under ISO definitions
•     ICH Q2(R1) and revision in 2021 to (R2) & Q14
•     Approaches to quantifying MU and Error Budgets
•     Quantifying uncertainties with a very simple example; a reference standard solution
•     Shape of errors
•     Statistical assumptions for Error budgets

Measurement Uncertainty in Calibration and Qualification of Analytical Instrumentation

•     Qualification, Calibration & Validation (QCV)
•     Experimental Errors
•     Calibration example of a UV spectrophotometer
  •         Wavelength accuracy
  •         Sensitivity; DL & QL

Measurement Uncertainty in the Validation of Analytical Methods

•     Holistic approach of MU
•     Case study example; Error Budget Process
•     Step 1: Description of the measurement process
•     Step 2: Specification of the measurand
•     Step 3: Identification of uncertainty sources
•     Steps 4 & 5: Quantification and combination of uncertainties

Measurement Uncertainty without the Maths; an Introduction to Monte Carlo Simulation

•     Monte Carlo Simulation (MCS) modelling
•     Principles behind MCS for MU
•     Example 1: Making a standard solution of a certified reference material (CRM)
•     Example 2: Leachable cadmium determination by Atomic Absorption Spectrometry (AAS)
•     Pros & Cons for MCS

Method Transfer; Success or Failure?

•     Case Study with interactive workshop

Process Performance and Reportable Values

•     What is a reportable value?
•     OOS, OOE & OOT
•     Process performance and process capability
•     ICH precision approach
•     USP <1010>

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