PAT WG sponsored session at IFPAC 2014 – “Multivariate Model Validation in a Quality Environment”
January 23, 2014
Meeting
The IQ ALG PAT WG is sponsoring a session at the 28th International Forum and Exhibition Process Analytical Technology (IFPAC 2014). The session, “Multivariate Model Validation in a Quality Environment” is scheduled for Jan 23, 2014. The goal of the session is to discuss current approaches to Multivariate Model Validation, incorporating industrial, academic and regulatory perspectives. Click here for additional information about IFPAC 2014.
Multivariate Model Validation in a Quality Environment: An International Consortium for Innovation and Quality in Pharmaceutical Development Session (IQ)
Chair(s): Doug Both and George L. Reid
Development or Validation of MV Methods
Lorenz Liesum, Novartis Pharma, Basel, Switzerland
Risk Based Method Development and Validation for NIR Based Quantitative Methods of Formulated Pharmaceutical Products
Gary McGeorge, Bristol-Myers Squibb, New Brunswick, NJ
Scientific Discussion on Variable Selection
Carl Anderson, Duquesne University, Pittsburgh, PA
Use of Multivariate Techniques and Experimental Design for Development of Innovative Manufacturing Quality Systems
Anna Persson, Umetrics, Wilmington, MA
Equivalency Testing: The roles of Assay Precision, Truth, Bias, Tolerance, Risk and Control Strategy in Setting Equivalence Margins
Kim E. Zerba, Sutan Wu1 and Gary McGeorge, Bristol-Myers Squibb, New Brunswick NJ, 1inVentiv Health Clinical, Lake Mary, FL
The PAT Model Lifecycle: Experience with Validation and On-going Verification
John Higgins, Charles E. Miller, Nathan Pixley, Manoharan Ramasamy, and Niya Bowers, Merck, West Point, PA
Validation of Multivariate Models with a Focus on Chemometric NIR Models
Bogdan Kurtyka, FDA, Silver Spring, MD
USP Spectral Library - Development Validation and Implementation
Michael A. Dotlich, Eli Lilly and Company
Validation and Application of Multivariate Models in the Context of Process Monitoring and Continuous Process Verification(CPV)
Lorenz Liesum, Novartis Pharma, Basel, Switzerland