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CMC Forum Summer 2016: Speaker Presentations
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Below you will find links to presentations from the CMC Strategy Forum Summer 2016. Please note that the slides are organized by presentation date.  If you have questions regarding the links, please contact the Project Coordinator Anna Lingel  at


Emerging Strategies for Drug Product Comparability and Process Validation  
Monday, July 18, 2016  
Analytical Tools for Drug Product  
Michael Koby Slides Click Here
Ashutosh Rao Slides  Click Here 
Tamer Eris Slides  Click Here
Jamie Moore Slides  Click Here 
Drug Product Comparability  
Ingrid Markovic Slides Click Here
Frank Maggio Slides Click Here
Eran Benjamin Slides Click Here 
Tuesday, July 19, 2016  
Drug Product Validation  
Kevin Maloney Slides Click Here
Patrick Donohue Slides Click Here 
Colleen Thomas Slides Click Here
Ellen Huang Slides  Click Here
Legacy Products and Life Cycle Management  
Thomas Damratoski Slides Click Here
Tracy TreDenick Slides Click Here
Barbara Breithaupt Slides Click Here
Simone Pitts Slides Click Here
Day One Summary Slides  Click Here
Day Two Summary Slides Click Here

Change Happens: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management  
Wednesday, July 20, 2016  
"The Problem Statement"  
Suzanne Murray Slides Click Here
Randall Lapcevich Slides Click Here
Gresham Weatherly Slides Click Here
Changing How We Make Change: ICH Q12 Global Status and Impact  
Anthony Ridgway Slides  Click Here
Wassim Nashabeh Slides Click Here
Mahesh Ramanadham Slides Click Here
Yasuhiro Kishioka Slides Click Here
Thursday, July 21, 2016   
Changing Lifecycle Management in Practice: The Reality of ICH Q12 Concepts   
Ashley Boam Slides Click Here
James Sesic Slides  Click Here
Kimberly Wolfram Click Here
To Infinity and Beyond... Managing the Myriad of Post-approval Changes in non-ICH  
Anders Vinther Slides  Click Here
Robert Laughner Slides Click Here
Jennifer Mercer Slides  Click Here
Summary Slides  Click Here

The views and opinions expressed in these PPT slides are those of the individual presenter and should not be attributed to CASSS, An International Separation Science Society, 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.


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