E22-25: Quality by Design Fundamentals for Analytical Chemists: A Continuous Improvement Paradigm for the Analytical Laboratory

 One-Day Course
Wednesday, Nov. 16; 8:30am – 5:00pm

 Dr. Zenaida Otero Gephardt, Otero Associates, Wilmington, DE

This course focuses on analytical laboratory quality by design (QbD) fundamentals. QbD basic principles will be discussed in the context of pharmaceutical and chemical industry applications. The conceptual framework for QbD operation in the analytical laboratory will be discussed with emphasis on relationships between critical quality attributes (CQA) and critical process parameters (CPP). QbD in experimental program design and data collection and analysis will be highlighted. Building quality in all phases of analytical laboratory experimentation and processing yields better decisions and more efficient and cost-effective operation. . Course participants will be able to immediately use the techniques presented to enhance their effectiveness in all aspects of laboratory operation, experimental design and assay development. Practical applications of QbD techniques in a wide range of industries will be highlighted.


Analytical chemists at all levels will benefit from this course. Laboratory supervisors and technical personnel involved in data collection, analysis and reporting will also benefit.


1. Introduction to QbD and General Background

2. Building Quality from the Initial Concept in Experiments and Assays

3. QbD Steps for Optimization of Experimental Programs

4. Critical Quality Attributes (CQA) and Critical Process Parameters (CPP)

5. Data Quality Measures

6. Benefits of Distribution Analyses over Deterministic Analyses

7. Metrics for Comparisons to Specifications

Dr. Zenaida Otero Gephardt
 is Associate Professor of of Chemical Engineering at Rowan University (Glassboro, NJ) where she has served as Director of Engineering and Assistant Dean. Dr. Gephardt is also a consultant through Otero Associates. Her research focuses on optimization, development and mathematical modeling of chemical processes and laboratory techniques. She has developed statistical models and experimental designs for a wide range of chemical processes including high pressure, supercritical systems, multi-phase systems and aquaculture applications. Dr. Gephardt has worked with a wide range of system scales ranging from bench scale laboratory systems to large-scale industrial application and has over 25 years of experience in analysis and optimization applications in the chemical process industry. She teaches on-site courses for industry and provides analysis and experimental design support. Dr. Gephardt is a Fellow of the American Institute of Chemical Engineers (AIChE) and was awarded a 2019 Eminent Engineer Award by the AIChE Minority Affairs Committee. She is a registered Professional Engineer in Delaware and holds a Ph.D. in chemical engineering from the University of Delaware.