Review ArticleReview
Design-for-Six-Sigma for Development of a Bioprocess Quality-by-Design Framework
Beth Junker, Mike Kosinski, David Geer, Rajiv Mahajan, Michel Chartrain, Brian Meyer, Peter Dephillips, Yang Wang, Randy Henrickson, Katie Ezis and Mark Waskiewicz
PDA Journal of Pharmaceutical Science and Technology May 2011, 65 (3) 254-286; DOI: https://doi.org/10.5731/pdajpst.2011.00739
Beth Junker
Mike Kosinski
David Geer
Rajiv Mahajan
Michel Chartrain
Brian Meyer
Peter Dephillips
Yang Wang
Randy Henrickson
Katie Ezis

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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 3
May/June 2011
Design-for-Six-Sigma for Development of a Bioprocess Quality-by-Design Framework
Beth Junker, Mike Kosinski, David Geer, Rajiv Mahajan, Michel Chartrain, Brian Meyer, Peter Dephillips, Yang Wang, Randy Henrickson, Katie Ezis, Mark Waskiewicz
PDA Journal of Pharmaceutical Science and Technology May 2011, 65 (3) 254-286; DOI: 10.5731/pdajpst.2011.00739
Design-for-Six-Sigma for Development of a Bioprocess Quality-by-Design Framework
Beth Junker, Mike Kosinski, David Geer, Rajiv Mahajan, Michel Chartrain, Brian Meyer, Peter Dephillips, Yang Wang, Randy Henrickson, Katie Ezis, Mark Waskiewicz
PDA Journal of Pharmaceutical Science and Technology May 2011, 65 (3) 254-286; DOI: 10.5731/pdajpst.2011.00739
Jump to section
- Article
- Abstract
- Introduction
- Related Initiatives
- QbD Project Approach
- Concept Phase Project Charter
- Concept Phase Current State Assembly
- Concept Phase House-of-Quality (HOQ) Development & Critical-to-Quality (CTQ) Summary
- Design/Optimize Phase Approach
- Design/Optimize Phase Outcome
- Verify Phase Identification of Gaps from the Design/Optimize Phase
- Internal Pilots and Mentoring Approach to Verify Detailed Design
- Implementation Planning
- Implementation Control Mechanisms
- Summarized Efforts Towards QbD Success
- Acknowledgements
- Footnotes
- References
- Figures & Data
- References
- Info & Metrics
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