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Midwest Regional Forum October 2018: Speaker Presentations
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Below you will find links to presentations from the October 2018 Midwest Regional Forum.  For speakers whom have given authorization, slides are organized in alphabetical order by the speaker's last name.  If you have questions regarding the links, please contact Catherine Stewart at cstewart@casss.org. 

 

Leveraging Platform Knowledge to Estimate Bioprocess Variability by Applying Bayesian Methodology

Jinxin (Jerry) GaoEli Lilly and Company

To view presentation, click here.

 

Case Study: Gaining Agreement with FDA on a Simplified, Rational Package and Shipping Qualification Program

Paul Harber, Parenteral Supply Chain, LLC

To view presentation, click here.

 

Leveraging Prior Knowledge to Accelerate CMC Programs

Elisabeth Krug, Eli Lilly and Company

To view presentation, click here.

 

A Regulatory Perspective on the Use of Prior Knowledge to Accelerate CMC Development 

Brian Roelofs, CDER, FDA

To view presentation, click here.

 

Leveraging Prior Knowledge during Biotherapeutics Development 

Margaret Ruesch, Pfizer, Inc.

To view presentation, click here.

 

The views and opinions expressed in these PPT slides are those of the individual presenter and should not be attributed to CASSS, its directors, officers, employees, volunteers, members chapters, councils or affiliates, or any organization with which the presenter is employed or affiliated.

These PPT slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries.  Used by permission.  All rights reserved.  CASSS and CASSS logo are registered trademarks.  All other trademarks are the property of their respective owners.


 

more Calendar

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