If done right, DoE should cost as much or less than the traditional approach to pharmaceutical development. This two-day course is a practical introduction to experimental design basics with applications to research, process assay development, and validation. A non-theoretical approach presents the concepts using arithmetic and simple graphics to understand and communicate your understanding of multifactor interactions.
World Health from FDA 2011 Process Validation Guidance to ICH Q8 requires the study of multivariate interactions.The Design of Experiments is how to do this.
The Quality By Design approach can either be budget crushing, time pushing additions at the end of development or it can be a cost saving tool built into the fabric of
your organization with which to balance the quality of theinformation gained against the time its going to take and the resources available before committing any monies to a project.
Agility and flexibility in the pharmaceutical industry requiresthe ability to manage complex post-approval change. The design of experiments is one such framework within which to capture,expand upon, and communicate knowledge.
This class looks at DoE strategy and introduces more advancedtechniques for both understanding variation and demonstrating that the commercial process is capable of producing quality product.