Integrated QbD Approach for Design Space Development Including Real Time Release
- Conference: AIChE Annual Meeting
- Year: 2011
- Proceeding: 2011 Annual Meeting
- Group:
- Type: Oral
- Room: Symphony III
- Location: Hilton Minneapolis
- Time: Thursday, October 20, 2011 - 8:30am-11:00am
Chair(s):
Sever, N. E., Abbott Laboratories
Co-chair(s):
Siegfried, A., RCPE GmbH
Quality by design approach is best implemented if it is integrated as part of the development process. Case studies demonstrating the integration of QbD into development and the benefits gained from a manufacturing, regulatory, quality and financial perspective will be presented. Improvements or lessons learned from the intergration of QbD should be highlighted. The session will also focus on the use of QbD principles as they relate to real time release regulatory applications and approvals.
Papers:
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Pricing
Individuals
2011 Annual Meeting
| AIChE Members | $150.00 |
| AIChE Graduate Student Members | Free |
| AIChE Undergraduate Student Members | Free |
| Non-Members | $225.00 |
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture only
| AIChE Members | $100.00 |
| AIChE Food, Pharmaceutical & Bioengineering Division Members | Free |
| AIChE Graduate Student Members | Free |
| AIChE Undergraduate Student Members | Free |
| Non-Members | $150.00 |