Use Statistical Thinking to find the Goldilocks Zone of Enhanced Sampling

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Use Statistical Thinking to find the Goldilocks Zone of Enhanced Sampling

  • Instructor: Katherine Giacoletti

  • Duration: 0 Min

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The Webinar will focus on understanding the importance of combining statistical analyses, visual data exploration, and process knowledge in making optimal enhanced sampling decisions. Specifically, participants will learn:


  • Why we perform enhanced sampling in Stage 2 (PPQ) and Stage 3a (initial CPV/OPV) – and when we may not need to
  • How enhanced sampling can optimally address the goals of Stage 2 (PPQ) and Stage 3a (initial CPV/OPV)
  • The role of statistical uncertainty in statistical intervals – and how knowing this enables better decision-making
  • How to use visual and statistical analyses to evaluate risk
  • Why automated statistical rules for enhanced sampling decisions can be wasteful and in some cases increase patient risk
  • Practical advice for enhanced sampling decisions to reduce patient risk and increase process understanding

Katherine Giacoletti

Partner at SynoloStats LLC

Eight years after the FDA Guidance which introduced the Lifecycle Approach to PV the need for enhanced sampling during Stage 2 (PPQ) and Stage 3a (initial CPV/OPV) in order to understand within and between batch variability is broadly recognized in the industry. One-size-fits all enhanced sampling plans or plans based on statistical rules can be highly ineffective, often resulting in too few or too many samples being taken. Such practices can fail to reap the business and patient benefit of additional process understanding. Statistical thinking is the primary enabler of choosing optimal sampling plans, or sampling plans in the “Goldilocks Zone.” This webinar will address the role of statistical uncertainty and the implications for designing sampling plans that optimally address the goal of better process understanding throughout the process lifecycle.

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