E17-17: Process Analytical Technology (PAT)/Quality by Design (QbD): Enhancing Effectiveness in the Analytical Laboratory

 One-Day Course  
Monday, November 13; 8:30am – 5:00pm

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

This course includes the fundamentals of the process analytical technology (PAT) and quality by design (QBD) combination that is beginning to significantly influence process development, submissions,  manufacturing and development and implementation of quality systems. The course will focus on how PAT/QbD can enhance the effectiveness of laboratory operations from technology to laboratory staff. Currently, PAT/QbD is mostly implemented in pharmaceutical and life sciences industries because its framework is especially beneficial for drug development and manufacturing. However, PAT/QbD methods are beginning to positively influence a wide range of industries. PAT and QbD allow for understanding of products and processes in a scientific and engineering sense, creating a superior match between requirements and the manufactured product or assay. This course will highlight how QbD can be used to select and implement process analytical technology (PAT) to reduce the number of steps required for operations, and to increase the effectiveness of each process step while continuously improving laboratory operations and processes. Specific examples from various industries and laboratories will be highlighted.

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. Introduction to PAT/QbD for the 21st Century
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 Basic DoE 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 applications, and 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 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.