{"id":1090,"date":"2013-04-02T15:44:45","date_gmt":"2013-04-02T19:44:45","guid":{"rendered":"http:\/\/easinc.org\/wordpress\/?p=1090"},"modified":"2016-02-23T11:33:21","modified_gmt":"2016-02-23T16:33:21","slug":"e13-quality-by-design-a-new-paradigm-for-the-analytical-laboratory-i","status":"publish","type":"page","link":"https:\/\/eas.org\/2024\/e13-quality-by-design-a-new-paradigm-for-the-analytical-laboratory-i\/","title":{"rendered":"E15-36: Quality-by-Design (QbD) Fundamentals for Analytical Chemists: A New Paradigm for the Analytical Laboratory"},"content":{"rendered":"
\n

\u00a0<\/b>One-Day Course<\/span><\/i><\/b><\/p>\n<\/div>\n

Dr. Zenaida Otero Gephardt, Rowan University, Glassboro, NJ<\/p>\n

COURSE DESCRIPTION
<\/span><\/b><\/p>\n

This course includes the fundamentals of quality-by-design in the analytical laboratory. \u00a0The background and basic principles of QbD will be discussed in the context of applications in the pharmaceutical and chemical industries. \u00a0The conceptual framework for QbD operation in the analytical laboratory will be discussed in detail with emphasis on critical quality attributes and critical process parameters (CQA, CPP). \u00a0QbD in experimental program design, data collection and analysis, risk assessment and cause-effect analysis will be highlighted. Building quality in all aspects and phases of analytical laboratory experimentation and processing results in 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.\u00a0 Practical applications will be used to demonstrate QbD techniques throughout the course.<\/p>\n

WHO SHOULD ATTEND
<\/span><\/b>Analytical chemists at all levels will benefit from this course.\u00a0 Laboratory supervisors and technical personnel involved in data analysis and reporting will also benefit.<\/p>\n

\n
\n

TOPICS
<\/b><\/span>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. Metrics for Comparisons to Specifications
7. Metrics for Detection of\u00a0 Variables\u2019 Impact on Experiments and Investigation
8. Continuous Improvement Techniques in the Laboratory
9. QbD of Experiments (Design of Experiments): Basics and Motivation
10. Cause-Effect and Risk Assessment Analysis<\/p>\n<\/div>\n<\/div>\n

<\/a>ABOUT THE INSTRUCTOR
<\/span><\/b>Dr. Zenaida Otero Gephardt<\/b> 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.\u00a0 Her research focuses on optimization, development and mathematical modeling of chemical processes and laboratory techniques.\u00a0 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.\u00a0 Dr. Gephardt has worked with a wide range of system scales ranging from bench scale laboratory systems to large-scale industrial applications.\u00a0 Dr. Gephardt has over 20 years\u2019 experience in analysis and optimization applications in the chemical process industry.\u00a0 She teaches on-site courses for industry and provides analysis and experimental design support.\u00a0 Dr. Gephardt holds a Ph.D. in chemical engineering from the University of Delaware and is a registeredProfessional Engineer in Delaware\u00a0and a Fellow of the American Institute of Chemical Engineers.<\/p>\n

.<\/p>\n","protected":false},"excerpt":{"rendered":"

\u00a0One-Day Course Dr. Zenaida Otero Gephardt, Rowan University, Glassboro, NJ COURSE DESCRIPTION This course includes the fundamentals of quality-by-design in the analytical laboratory. […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-1090","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/pages\/1090"}],"collection":[{"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/comments?post=1090"}],"version-history":[{"count":17,"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/pages\/1090\/revisions"}],"predecessor-version":[{"id":3903,"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/pages\/1090\/revisions\/3903"}],"wp:attachment":[{"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/media?parent=1090"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}