Implement Patient-Focused Statistics Across the Process Validation Lifecycle

10:45 AM – 5:30 PM EST 

FDA’s 3-Stage life cycle approach is the backbone of all validation and is globally recognized as the gold standard. Statistics and statistical methods are mentioned 14 times throughout FDA’s 19-page Process Validation Guidance. Although the concept was introduced in 2011, industry still struggles with using statistics effectively throughout the validation life cycle. KENX is proud to present this virtual training led by industry’s leading statisticians and Subject Matter Experts. Whether you routinely apply statistical methods or are a statistics novice, this seminar provides validation, manufacturing science and quality professionals with the know-how necessary to efficiently and correctly leverage statistics throughout the process validation lifecycle

Top Reasons to Attend

  • Use Statistics as a Risk-Analysis Tool Throughout the PV Lifecycle
  • Statistics in Process Development – Accelerate Development of a Robust Control Strategy
  • Develop a Control Strategy Using Design of Experiments (DOE)
  • Determine Proven Acceptable Ranges (PARs) or Design Space
  • Use at Modern Statistical Tools for Accelerated Development & Novel Therapies
  • Link Knowledge Across the Lifecycle & Optimize in PPQ
  • Develop Sampling Plans to Demonstrate Process Performance
  • Define Statistical Confidence and Relate to Sample Size and Statistical Uncertainty
  • Design PPQ Sampling Plans for Continuous and Pass/fail Attributes
  • Describe a Risk-based Approach to Determining the Number of PPQ Batches
  • Learn Key Elements in Designing any Continued/Ongoing Process Verification Program
  • Develop a Targeted, Practical Approach to Enhanced Sampling During Stage 3a
  • Understand Key Components of Commonly Used Control Charts, and Know How to Choose Which to Use
  • Overcome leptokurtophobia (irrational fear of non-Normality) and Learn What to Watch For
  • Learn to Be a Statistical Sleuth with Exploratory Data Analysis & Statistical Thinking to Simplify and Accelerate Investigations
  • Identify the Hidden Dangers and Learn How to Avoid Pitfalls When Using Historical Data

Personnel in the Following Environments Should Attend:

  • Process Validation
  • QA/QC
  • Engineering
    • Process
    • Design Control
    • Product Development
  • Regulatory Affairs
  • Process Scientist
  • Six Sigma Green Belt and Black Belt
  • Continuous Improvement Manager
  • Statistician
  • Regulatory Affairs
  • Manufacturing
  • Laboratory

This event is also appropriate to business development and sales managers that offer innovative solutions for quality validation and engineering professionals in the life science industry.


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.

© Copyright 2020 Knowledge Exchange Network LLC. All Rights Reserved