Pharmaceuticals |
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| Session 176 - Quality by Design In the Pharmaceutical Industry | |||
| Modernization of regulatory processes in the pharmaceutical industry has led to several innovative approaches to risk-based implementation of Quality by Design. Speakers for this session should include topics describing their application of QbD principles with examples of determination of critical process parameters (CPPs), mapping of design spaces (DS), real time process monitoring, and the determination of appropriate control strategies for small and large molecule drug product and drug substance processes. This session will be followed by a QbD roundtable panel discussion with invited speakers | |||
| Chair: | Kevin D. Seibert | ||
| CoChair: | John F. Peragine | ||
| CoSponsor(s): | Process Development Division |
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| 176a | Establishing Multivariate Specifications for Incoming Materials Using Data from Multiple Scales Salvador Garcia-Munoz |
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| 176b | The Concept of Qbd Applied to API Starting Materials Timothy J. Watson |
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| 176c | Quality by Design and Design Space Enabling Continuous Improvements for a Commercial Solid Oral Drug Product Mary T. Am Ende, Georg Bernhard, Veronica Lubczyk, Ulrich Dressler, Thomas Katzschner, Andrew Prpich, Holger Weyhers |
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| 176d | Prospective Analysis of a Manufacturing Rig and Determination of Routine Operating Capability In Preparation for a New Product Launch Utilizing Quality by Design Principles Claire Twomey, Helena Ryan, Niamh Warren, Kevin D. Seibert |
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| Break |
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| 176e | Process Modeling Based Approach towards Quality by Design for An API Synthetic Step Shawn Brueggemeier, Emily Reiff, Olav Lyngberg, Lindsay Hobson, Jose Tabora |
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| 176f | Integrating Design for Six Sigma Tools and Qbd Concepts In Hot Melt Extrusion Process Development Luke Schenck, Adam ChEn, Michael Lowinger, Gregory M. Troup, Amanda Sinha, Jennifer Ho, Brit L. Rudeen, Stephanie Robison, Celia Cruz |
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| 176g | Design Space of Drug Product: Empirical Modelling Based on Multivariate Projection Methods T. Kourti |
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