Statistical Methods for Process Validation Masterclass

Statistical Methods for Process Validation

Days

Hours

Minutes

Seconds

This course includes:

Collaborative environment that
encourages interaction
Case studies and Q&A sessions
Training materials
Tools and techniques to apply
immediately in your role
Recording access
Certificate of completion

Course outline

Process validation is more than a compliance checkbox—it’s the backbone of quality assurance and operational success. This masterclass provides a deep dive into advanced statistical methods, ensuring you can address the most pressing challenges with precision and confidence. From Process Performance Qualification (PPQ) to Design of Experiments (DOE) and beyond, every module is packed with actionable strategies. Imagine confidently tackling root cause analyses, building bulletproof sampling plans, and designing CPV programs that set a gold standard in your organization.

What You’ll Gain

Navigate Regulatory Complexity with Confidence
Tired of navigating a maze of FDA, EMA, and ISO requirements? This course demystifies the lifecycle approach to process validation, helping you translate theory into tangible results with sampling plans, stability testing, and shelf-life analysis.
Manage Variability and Reduce Risk
Variability—it’s the nemesis of consistency. Learn how to harness tools like variance components, DOE, and SPC to bring predictability and reliability to your processes. Picture the confidence of knowing your systems are rock solid.
Improve Efficiency and Make Data-Driven Decisions
Do inefficiencies in data analysis slow you down? We’ll show you how to design efficient CPV programs and connect PPQ sampling plans to actionable insights, all while leveraging cutting-edge data visualization techniques to expedite root cause analyses.

Why This Masterclass?

Learn from the Best
Imagine learning from a trainer who takes complex statistical concepts and transforms them into simple, actionable solutions. That’s exactly what you’ll get.
Focused Training with No Fluff
Every module zeroes in on the crux of process validation: from DOE and PPQ sampling plans to CPV and SPC strategies. No distractions, no irrelevant topics, just laser-focused content.
Practical Insights, Beyond Just Numbers
Statistics tell a story, and this masterclass teaches you how to interpret and apply it. Step outside the spreadsheet, analyze real-world data, and make informed decisions that drive quality and compliance.

Who Should Attend

Process Development teams
Manufacturing Science and Technology teams
Qualified and Responsible Persons (QPs, RPs)
Validation and Qualification teams
Contract Manufacturing organizations (CMOs) and Contract Development and Manufacturing organizations (CDMOs)

About Trainer

Tara Scherder brings over 20 years of unparalleled experience in the pharmaceutical industry, where
she has worn many hats—statistician, process engineer, educator, and master black belt. As the

principal at SynoloStats, Tara passionately advocates for the integration of statistics and science to
drive patient and business success.
With a unique blend of statistical expertise and deep knowledge of manufacturing platforms, analytical
sciences, and CMC requirements, Tara empowers professionals to:

Enhance knowledge and optimize manufacturing processes.
Streamline analytical and business workflows.
Effectively manage risk while meeting regulatory requirements.

A recognized thought leader, Tara is a frequent speaker at industry forums and a published author on the practical application of statistical methods for Lifecycle Process Validation. Her teaching style is rooted in practicality, ensuring complex concepts are accessible and immediately applicable.

Educational Background: