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Confidence in Analytical Results and Measurement Uncertainty

: 30 Sep 2021

Sector : Pharmaceutical

Type : Training, Webinar


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>

Visit www.gmp-compliance.org

Venue

Online event


Organizer

ECA Academy
Phone : +49 (0)6221 84 44 0
Email : info@gmp-compliance.org
Visit : https://www.gmp-compliance.org/training


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RSSL Sterility Webin...
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2021 PDA Pharmaceuti...







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