Process Validation Statistics for Non-Statisticians

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Process Validation Statistics for Non-Statisticians

  • Instructor: Tara Scherder

  • Duration: 60 Min

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Process understanding and risk management are essential to the Lifecycle Approach to Process Validation, and statistical thinking is a key enabler to both.  This webinar presents common statistical methodologies used for process design (Stage 1), performance qualification (Stage 2), and continued/ongoing process validation (Stage 3).



  • Know the fundamental reasons to leverage statistical methods across the product lifecycle
  • Understand variability, regulatory expectations, and the connection between risk and control strategy
  • Review statistical intervals, sampling plans, and ongoing monitoring using SPC and process capability
  • Learn common pitfalls in the use of statistics and how to avoid them


Tara Scherder

Partner, SynoloStats LLC

Tara has over 25 years of experience in the chemical and pharmaceutical industries as a statistician, process engineer, and master black belt. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams across the product lifecycle for the spectrum of product platforms. As partner at SynoloStats, she passionately shares the opportunity for patient and business benefit through the combination of statistics and process. Tara earned a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University.

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