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Application of Statistics in the Pharmaceutical Process Validation Lifecycle

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 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

Previous Attendee Acclaim:

This class was a real eye-opener to statistics coming from someone who did not have a strong statistical background. Excellent course!

Manager, Process Validation, Mylan Pharmaceuticals

Knowledgeable speakers making complex issues and terms simple to understand!

Research Scientist, Charles River Laboratories

IVT’s Statistics in Validation

Application of Statistics in the Pharmaceutical Process Validation Lifecycle

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 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

Previous Attendee Acclaim:

This class was a real eye-opener to statistics coming from someone who did not have a strong statistical background. Excellent course!

Manager, Process Validation, Mylan Pharmaceuticals

Knowledgeable speakers making complex issues and terms simple to understand!

Research Scientist, Charles River Laboratories