In this pre-recorded webinar, Siegfried Schmitt describes the current understanding and expectations for implementation of quality-by-design (QbD). Approaches, benefits, and potential pitfalls, especially for regulatory applications, are be presented.
After viewing the webinar, participants will be able to:
- Understand the regulators' expectations for QbD
- Make the business case for a QbD program
- Understand what new / additional expertise will be needed to:
- Establish a design space
- Describe a design space in the submission.