12 – 14 October 2026
TRAINING TIMES
Learn how to design, screen, and optimize assays to ensure fitness for use, reliability, and regulatory suitability.
Understand how ICH Q2, Q14, and USP chapters shape assay validation, acceptance criteria, and system suitability.
Apply models like parallel line, slope ratio, and 4PL to evaluate potency, variability, and robustness.
Develop assays that withstand variability, meet robustness expectations, and remain reliable post-validation.
Three days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in one place - before, during, and after the course.
Receive a digital certificate (also LinkedIn-ready) that verifies your skills in strategic trial planning.
Learn how to plan and optimize assays using key statistical tools, DOE, and validation parameters.
Justify system and sample suitability, limits, and decision thresholds using robust analytical models.
Understand when and how to use models like 4PL, parallel line, and slope ratio for relative potency.
Use experimental design and response surface methods to confirm assay robustness under varying conditions.
Translate assay data into defensible conclusions for validation, post-validation, and regulatory decisions.
Designed for professionals who want to enhance their expertise and advance their careers
Statistical Outsourcing Services, USA, Independent Consultant
Steven Walfish brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues. Steven has experience applying statistical methods to analytical method verification and validation and stability analysis. Mr. Walfish holds a Bachelor of Arts in Statistics from the University of Buffalo, Master of Science in Statistics from Rutgers University and an Executive MBA from Boston University.
Learn More →
Take a sneak peek at the trainer's presentation.
View PDF →
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
“The DoE and validation modules stood out. They were highly relevant and helped connect the concepts to real CMC work.”Divya Venkatesh
“I really liked that the class had a varied group of participants, which made the discussions more engaging. Steven explained all of the topics very clearly and answered every question thoroughly, making the material easy to understand.”Christina Fragkaki
“Steven was very helpful and knowledgeable. He also presented in a way that was both easy to follow and engaging.”Jerald Aurellano