E19-21: Process Analytical Technology (PAT) and Quality by Design (QbD) Integration for Effectiveness in the Analytical Laboratory

One-Day Course
Monday, Nov. 18; 8:30am – 5:00pm

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

This course focuses on the integration of process analytical technology (PAT) and quality by design (QbD), a combination that is significantly influencing product and process development, regulatory submissions, manufacturing, and quality systems. PAT/QbD integration enhances understanding and efficiency at every step of development and manufacturing. Implementation of PAT/QbD integration creates a superior match between requirements and the manufactured product or assay. PAT/QbD integration can reduce the number of steps in operations and increase individual process step effectiveness, while continuously improving laboratory operations and processes. Applications in a wide range of industries will be highlighted throughout the course.

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 PAT/QbD Integration
2. QbD Directed PAT Selection and Implementation
3. PAT Transfer from the Laboratory to Production Environment
4. Identification of Critical Process Attributes (CQA) and Critical Process Parameters (CPP)
5. ‘Smart’ Tools: Design Space and Analysis
6. Control Strategies
7. Continuous Improvement Techniques for PAT in the Laboratory
8. PAT/QbD Teams and Operations

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 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 20 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 is a registered Professional Engineer in Delaware. She holds a Ph.D. in chemical engineering from the University of Delaware.