E14 – Quality-by-Design: A New Paradigm for the Analytical Laboratory II

Quality-by-Design (QbD): A New Paradigm for the Analytical Laboratory II:
Design of Experiments (DOE) for Analytical Chemists

One-Day Course

Dr. Zenaida Otero Gephardt, Rowan University, Glassboro, NJ

Design of Experiments (DOE) is one of the cornerstones of quality-by-design (QbD) in the laboratory. Optimization of experimental design techniques offers the advantage of minimizing the number of experiments required in the laboratory.  This improves the efficiency of the laboratory staff and reduces the cost of operation.  Experimental design techniques often yield better data, and results that are more meaningful and easier to interpret. Critical quality attributes (CQA) are identified and effects of critical process parameters (CPP) are ascertained and quantified in the most efficient manner.  In addition, experimental design allows for optimization of continuous improvement techniques in the laboratory. Many design techniques are simple to use and only require a calculator or spreadsheet software.  Experimental design techniques allow laboratory staff to focus on experimental development and to mainstream laboratory operations and regulatory matters.  This course will provide participants with analysis tools they can immediately use in their laboratories including an introduction to available experimental design software.  Practical applications will be used to illustrate experimental designs throughout the course.

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

1. Background and Introduction to QbD Experimental Design Optimization
2. Experimental Designs for Simple Linear and Pseudo-Linear Systems 
3. Identifying Key Variables Using Experimental Designs
4. Experimental Designs for Initial Stages of Experimental Program: Scouting Designs
5. Experimental Designs for Complex Systems
6. Experimental Designs for Mixtures
7. Continuous Improvement: Evolutionary Experimental Designs

Dr. Zenaida Otero Gephardt is Associate Professor 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 Keil 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 applications.  Dr. Gephardt has over 20 years’ 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 holds a Ph.D. in chemical engineering from the University of Delaware and is a registered Professional Engineer in Delaware.