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Application of QbD Concepts

Key learning objectives:

Understand the drivers for QBD during
biopharmaceutical Development
Learn how to develop a framework for identifying
critical process parameters
Learn how to define relationships between critical
process parameters and quality attributes
Learn how to create process design spaces and
integrate these into an overall control strategy

Webinar Overview

The International Conference on Harmonization Q8 (revision 2) guidelines on Pharmaceutical Development describe the principles of quality by design (QbD) and were approved in 2008. Yet in a 2014 survey of the biopharmaceutical industry only 16% of respondents said they had fully implemented QbD. In order to facilitate understanding and aid adoption of the technique, Parker domnick hunter will present a case study illustrating the core principles, useful frameworks and points to consider when implementing a QbD strategy.
This webinar describes how a control strategy can be defined based on sound science and quality risk management through the use of a case study based upon the sterilization of a biopharmaceutical by normal flow filtration.  An approach to establishing process parameters based on critical quality attributes will be discussed along with the use of multivariate experiments using scale down models for process characterization.
This information will help biomanufacturers integrate their process control strategy into their overall control strategy and ultimately their post approval life cycle management plan.

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