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Measure, Analyze and Optimize Validation & GMP Processes through the Use of Meaningful Statistics

June 20-22, 2017
  • Philadelphia, PA

IVT’s 3rd Annual 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.

The FDA and global regulatory authorities require the recognition of variation as well as the control of variation throughout the entirety of the product lifecycle; the application of statistical methods in the measurement and analysis of data throughout the stages of process validation are critical to this effort.

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.

Choose from 16 Deep-Dive Sessions
Providing Practical Takeaways, Including:

  • Examine FDA Quality Metrics, Data Integrity and Application of
    Statistics throughout Process Validation in a Global Economy
  • Analyze the Process Validation Lifecycle and the Need for
    “Fit for Purpose” Statistics
  • Learn to Use the Right Statistical Tools to Solve Your Problems in
    Process Validation
  • Assess Evolving Trends in the Use of Statistics for Process Validation
  • Determine Sampling Plans Utilizing Risk Analysis
  • Biologics — A Case Study in Non-Normal Data
  • Understand the Benefit and Danger of Statistical Acceptance Criteria
    for PPQ
  • Use Statistics to Identify and Understand Process Capability and Control — Statistical Process Control and the Use of Control Charts
  • Utilization of Continued Process Verification (CPV) —
    Statistical Tools for Process Control and Process Improvement

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

June 20-22, 2017 | Wyndham Historic District | Philadelphia, PA