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March 6-7, 2019
  • Philadelphia, PA

The FDA and EMA mandate the use of statistics in validation and production as highlighted in their respective process validation guidance’s. The application of statistical methods in the measurement and analysis of data throughout the stages of process validation are critical to this effort.

IVT’s 4th Statistics in Validation conference provides relevant examples, expanded tutorials and in-depth case studies of how, when and where to use statistics in various stages of the validation lifecycle to ensure quality, safety, and efficiency, as well as adhere to regulatory expectations.

Join statisticians and non-statisticians to gain actionable strategies and practical methods on the proper utilization of statistics in your GMP processes to evaluate stability and capability, identify variability, and indicate potential improvements.

  • Examine FDA quality metrics, data integrity and application of statistics throughout process validation
  • Understand the process validation lifecycle and determine the applicable statistical analysis
  • Evolving trends in the use of statistics for process validation
  • Determine sampling plans utilizing risk analysis
  • How to use statistics to understand process capability and control

IVT’s 4th Statistics in Validation

The FDA and EMA mandate the use of statistics in validation and production as highlighted in their respective process validation guidance’s. The application of statistical methods in the measurement and analysis of data throughout the stages of process validation are critical to this effort.

IVT’s 4th Statistics in Validation conference provides relevant examples, expanded tutorials and in-depth case studies of how, when and where to use statistics in various stages of the validation lifecycle to ensure quality, safety, and efficiency, as well as adhere to regulatory expectations.

Join statisticians and non-statisticians to gain actionable strategies and practical methods on the proper utilization of statistics in your GMP processes to evaluate stability and capability, identify variability, and indicate potential improvements.

  • Examine FDA quality metrics, data integrity and application of statistics throughout process validation
  • Understand the process validation lifecycle and determine the applicable statistical analysis
  • Evolving trends in the use of statistics for process validation
  • Determine sampling plans utilizing risk analysis
  • How to use statistics to understand process capability and control