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Session 9A: Process and Product Monitoring for Sustained Quality
Session Chair(s)
Christine Moore, PhD
Executive Director, Global External Advocacy and Standards
Organon & Co., United States
This session will describe the advantages of product and process monitoring beyond minimal GMP requirements. Such efforts are aligned with FDA efforts to modernize manufacturing and can aid in sustained process performance, that may be reflected in quality metrics. Industry speakers will discuss implementing a comprehensive system to monitor process performance and support continual improvement and how multivariate analysis of process data can aid fault diagnosis and correction. Additionally, an FDA speaker will provide a perspective of the advantages of process monitoring over the product life cycle.
Speaker(s)
Improving Process Robustness via Continuous Process Monitoring in Drug Product Manufacturing – Case Studies
Stelios Tsinontides, PhD, MA
FDA, United States
Office Director, OPMA, OPQ, CDER
The Application of Real-Time Multivariate Data Analysis to Improve Equipment Health and Process Consistency
Louis Obando, PhD
Merck Research Laboratories, United States
Principle Scientist
Design and Implementation of Process Monitoring Tools for Continuous Improvement
Christine Capacci-Daniel, PhD
FDA, United States
Consumer Safety Officer, Office of Process & Facilities, OPQ, CDER
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