Evaluating and Trending of Process Data for Continued Process Verification and for Annual Product Quality Review (APR/PQR)

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

A practical course on charting, interpreting and trending of data from the pharmaceutical plant with Minitab® 18, for Continued Process Verification and for the Product Quality Review

Content Day 1
  • Introduction (including regulations)
  • Content of APR/PQR
  • Organization and presentation of process data
  • Acquaintance with Minitab® 18
  • Variation of process of data
  • Exercises
Content Day 2
  • Control Charts of Grouped Data
  • Control Charts of individual data
  • Three-Way Charts
  • Control charts for attributes
  • Exercises
Content Day 3
  • Tools for detecting a trend and shift in process average and/or process variability
  • Capability and stability of a process
  • Introduction to Change-Point Analysis
  • SPC rules in the Real-World of pharmaceutical process data
  • CPV/OPV Plan
  • Workshops/Case studies
  • Exercises

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