Application of Predictive Multivariate Analysis to Product Quality Research: Case Studies.


05th February 2021 | 10:00am EST | Dr. Yifan Wang, Manufacturing Assessor, FDA CDER |BOOK FREE SEAT FOR THIS WEBINAR

Multivariate analysis is rapidly establishing itself as a data analysis tool for pharmaceutical product quality research. FDA CDER’s laboratory research capabilities play an essential role in supporting science-based decision making. Data generated in laboratory settings often require meaningful analysis so that data can be turned into information and information into insight. This webinar introduces a framework of predictive multivariate analysis techniques that can be applied to product quality research, including multivariate analysis of variance (MANOVA), principal component analysis (PCA), partial least squares regression (PLS), etc. Case studies are presented to demonstrate that the framework can be helpful in various aspects related to chemistry, manufacturing, and control. The case studies will highlight multivariate analysis for continuous manufacturing of solid dosage forms, process analytical technology for bioprocessing, and predictive modeling for analytical chemistry.

Presented by Dr. Yifan Wang, Manufacturing Assessor, FDA CDER

Dr. Yifan Wang is a manufacturing assessor at the FDA CDER’s Office of Pharmaceutical Manufacturing Assessment for assessing IND, NDA, and ANDA submissions, as well as participating pre-approval inspections. She serves as a technical expert for solid dosage forms. With her expertise in advanced data analytics, Yifan has worked on various aspects of emerging technologies such as continuous manufacturing. Yifan is certified by the American Society for Quality as a Six Sigma Black Belt and a certified pharmaceutical GMP professional. She is the award recipient of Maryland Law Scholar in 2019 and FDA CDER Group Recognition Award in 2018 and 2017. Yifan Wang received her B.S. in Pharmaceutical Engineering from Dalian University of Technology, China, and a Ph.D. in Chemical Engineering from Rutgers University, U.S. She also received training in chemical technology and biotechnology from the Royal Institute of Technology, Sweden.


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