Statistical Tools for QC and R&D Laboratories

Below is an example of a 3 day inhouse training course.

This is a three-day practical course aimed at teaching the most important basic statistical tools required by personnel of Quality Control, Quality Assurance and Research and Development Laboratories. The course includes hands-on training with Minitab® 18 software for solving a vast amount of examples and exercises by the participants from the pharmaceutical industry. The course is intended to teach you statistical tools for answering the following common questions:

  • Introduction
  • Acquaintance with Minitab® 18
  • Organization and presentation of data
  • How variable are your results?
    • precision, variance
    • standard deviation  and geometric standard deviation, outlier tests, method repeatability and intermediate precision)
  • How comparable are your results?
    • t-Test for a single average, for two averages, paired t-test
    • uncertainty of a result
  • How selective are your results?
    • Types of errors: Types 1 and 2 (Example: False OOS results in testing API)
    • Confounding results
    • Power of a test
  • Statistics of Linear Curves
    • least square regression
    • quality of fit to a linear curve
    • when a single-point calibration curve is justified
    • confidence interval of a line
    • understanding the shelf-life of a drug product
  • How specific are your results?
    • beta error
    • power of a calculation
  • How equivalent are your results?
    • comparability of two sets of results by two methods/instruments/Analysts
    • equivalence of two methods during method transfer

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