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
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
- Control Charts of Grouped Data
- Control Charts of individual data
- Three-Way Charts
- Control charts for attributes
- Exercises
- 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