Using Quality by Design to Improve Manufacturing - Webinar CD/Transcript
Using Quality by Design to Improve Manufacturing: How Sponsors and CMOs Speed Production and Improve Compliance
The life sciences industries are going through enormous financial changes that are forcing them to do more with less. Mergers, acquisitions, the patent cliff and more are forcing sponsors and CMOs to finds ways to speed up production while still maintaining quality and compliance.
FDA is promoting the use of Quality-by-Design (QbD) as an approach for helping pharmaceutical and biotech companies speed up production, fine-tune continuous manufacturing and improve quality.
QbD is a disciplined and systematic approach for effectively creating and communicating the processes and systems needed to build quality into the product at every stage of production.
This presentation will present a holistic approach to QbD with a focus on how the needed process understanding is developed to enable effective process development, quality improvement and maintain compliant operations.
You will learn:
- The risks associated with current manufacturing — there’s more than you read in the papers
- QbD – what and why the FDA is focusing on it – and how they expect firms to deploy it while maintaining compliance
- How QbD benefits both sponsors and their CMOs
- Best practices for understanding and reducing risk
- Experimental strategies for process design
- Identifying the critical control parameters (CCP)
- Right data in the right amount at the right time
- Proven techniques for developing a QbD monitoring system for process performance and product quality
- How to use QbD to enable successful tech transfer — poor tech transfer has doomed many manufacturing executive’s careers
- When and how to revise your SOPs, training programs and general culture to effectively deploy QbD in an organization
- Years of tips to success and traps to avoid in the effective implementation of QbD
The concepts and methods involved will be introduced and illustrated with pharmaceutical case studies and examples. Commonly held misconceptions will be addressed and a holistic approach to QbD will be presented.