Quality by Design (QbD) using DOE
Date: August 24, 2020
Time: 10:00 – 11:00 PM Eastern
Instructor: Heath Rushing
Register via email at email@example.com
This webinar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). Specifically, this webinar demonstrates the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.
- set meaningful specifications
- evaluate information from assay validations
- analyze screening and response surface designs
- link information from pharmaceutical development studies to a process control plan.