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Activity Number: 349 - Quality, Reliability and Measurement System
Type: Contributed
Date/Time: Tuesday, July 30, 2019 : 10:30 AM to 12:20 PM
Sponsor: Quality and Productivity Section
Abstract #305255 Presentation 1 Presentation 2
Title: Extracting Practical Value from Experimental Designs Through Simulation
Author(s): Rob Lievense*
Companies: JMP
Keywords: Quality by Design (QbD); Design of Experiments (DOE); Critical Quality Attributes (CQA); Pharmaceutical Product Design; Regulatory Compliance; Statistical Simulation
Abstract:

Pharmaceutical product development is increasingly involving Quality by Design (QbD) elements through the use of statistical design of experiments (DOE). The structured, multivariate experiments that result are used to define the design space of a process to ensure compliance to regulatory requirements for product submissions. Compliance need not be the sole purpose of quality by design as statistical modeling also can provide great practical value to stakeholders.

This presentation utilizes the multivariate model and the known trends of process inputs to create simulations for the expected population of the manufactured drug product. The simulated results are explored with data visualization techniques to develop a robust control space for the manufacturing process. The end result is a capable process that is likely to produce high quality drug products that are compliant to specifications for critical quality attributes throughout the product life cycle.


Authors who are presenting talks have a * after their name.

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