Advanced Statistics for Quality Control and Quality Assurance (2 days)

  Content Day 1
09.00 - 09.45 Optimisation of Precision (of the Reportable Value, Replication Strategy)
  • Reducing the precision of the reportable value by averaging
  • Impact of variance contributions obtained from precision studies
  • Optimisation of replications for reference standards
09.45 - 10.30 Workshop: Optimisation of Precision (of the Reportable Value, Replication Strategy)
  • Optimisation of number of injections/measurements
  • Sample preparations, and series/runs for physico-chemical assays and bioassays
10.30 - 11.00 Break
11.00 - 11.45 Precision Requirements
  • Acceptable precision - empirical and requirement-based
  • Derivation from specification limits (tolerance factors, measurement uncertainty, probability of normal distribution), for drug substance and drug products, bioassays, guard bands (internal limits)
11.45 - 12.30 Concentration Dependency of Precision (Horwitz Function)
  • Horwitz-function, repeatability approaching QL
  • Concentration dependence of injection precision and repeatability and their variance contributions
  • Acceptable precision for impurities
12.30 - 13.45 Break
13.45 - 14.30 Workshop: Uncertainty of Intermediate Precision
  • Reliability of intermediate precision, appropriate number of series/runs and determinations in precision studies
14.30 - 15.15 Assessment of Results including their Uncertainty
  • Simple and statistical evaluation
  • Confidence intervals of differences between means and of precisions
  • USP chapter
  • Combined evaluation of accuracy and precision including prerequisites
15.15 - 15.45 Break
15.45 - 16.30 Trend Analysis & Monitoring of Data
  • Trend test according to Wallis-Moore
  • Statistical control charts
  • Alert and control limits, out-of-control rules
  • Analytical monitoring parameters
  • Practice check
16.30 - 17.30 Workshop: Trend Analysis & Monitoring of Data
  • Evaluation of example data sets, selection of suitable control charts, selection of suitable
17.30 Final discussion
  Content Day 2
09.00 - 10.00 Regression and Calibration Models
  • Confidence and prediction intervals of the regression line
  • Statistical linearity tests, regression and concentration range
  • Weighted and non-weighted linear regression
  • Standard addition
10.00 - 10.30 Break
10.30 - 11.15 Trending in Stability
  • Approaches to identify out-of-trend results 
11.15 - 12.00 Detection and Quantitation Limit
  • Blank and analyte distribution
  • Linearity-based approaches
  • From precision 
  • Signal-to-noise ratio
12.00 - 13.15 Break
13.15 - 14.00 Workshop: Detection and Quantitation Limit
  • Dependence of QL from concentration range, determination of QL from precision, from signal-to-noise ratio
14.00 - 14.45 Attribute Testing (Discrete Data)
  • Distribution of discrete data
  • Binominal distribution
  • Defect classes, sampling plans, probabilities of acceptance
14.45 - 15.00 Break
15.00 - 17.00 Application Workshop
  • Selection of appropriate calculations and tests for examples
17.00 Final Discussion

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