Statistics in pharma – overview of risk management and data analysis methods

Training description: Risk management and statistical data analysis methods applied at particular stages of a product life cycle allow for developing an integrated and systematic approach to collection, analysis and storing of information/data related to products, manufacturing processes and components. Quality management tools enable identification of areas which pose the highest risk to product quality, resulting from the lack of knowledge of the product and process. Statistical data analysis tools make it possible to identify and control sources of variation, to transform information into knowledge and to understand the process.
The aim of the course is to familiarise its participants with practical and easy to use risk and statistical data analysis methods applied in production control. The course combines practical knowledge of specific issues concerning the pharmaceutical industry with the knowledge of risk and data analysis methods, based on data from the sector. Individual issues will be first discussed theoretically and then the participants’ knowledge will be developed during practical classes. After the course, the participants will be able to individually propose appropriate techniques of risk analysis, data visualisation and statistical assessment in a product life cycle.

Requirements: ability to work with a computer in the Windows environment.

Training programme:

1.Application of risk and statistical data analysis methods in the following fields:
  • process validation, on-going process verification,
  • periodical product review,
  • assessment of product stability tests,
  • manufacturing environment monitoring,
  • assessment of OOS / OOT results.
2.Data analysis methods – discussion and examples:
  • Descriptive statistics
  • Process stability analysis
  • Process capability analysis
  • Statistical acceptance plans
3.Risk analysis methods – discussion and examples:
  • Key definitions
  • Assumptions of risk management
  • Risk management implementation
  • Risk assessment
  • Risk management
  • Risk management review
  • Risk management communication
  • Risk management heuristics
  • Fault tree analysis
  • Cause and effect diagram
  • Assessment of the criticality of the influence on the quality
  • Risk Ranking and Filtering (RRF)
  • Preliminary Hazard Analysis (PHA)
  • Hazard and Operability Study (HAZOP)
  • Failure Mode and Effects Analysis (FMEA)
  • Hazard Analysis and Critical Control Points (HACCP)

Questions? Please contact our specialist team.


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