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CC = Baltimore Convention Center,    H = Hilton Baltimore
* = applied session       ! = JSM meeting theme

Activity Details

566 * ! Wed, 8/2/2017, 2:00 PM - 3:50 PM CC-339
Recent Advances in Quality Statistics and Process Validation of Pharmaceuticals — Topic Contributed Papers
Section on Risk Analysis , Biopharmaceutical Section , Quality and Productivity Section , ENAR
Organizer(s): Stan Altan, Janssen R&D, LLC
Chair(s): Jyh-Ming Shoung, Janssen R&D, LLC
2:05 PM Continued Process Verification - a Systems Approach Including Tips and Traps Ronald D Snee, Snee Associates, LLC
2:25 PM Recent Advances in Quality Statistics and Process Validation of Pharmaceuticals Lynne Hare, Statistical Strategies, LLC
2:45 PM Process Validation: Statistical Methods for Evaluating Uniformity of Dosage Units James Bergum ; Thomas Stepinac, Novartis
3:05 PM Improved Acceptance Limits for ASTM Standard E2810 Richard Lewis, GlaxoSmithKline ; Ailin Fan, North Carolina State University
3:25 PM Discussant: Stan Altan, Janssen R&D, LLC
3:45 PM Floor Discussion
 
 
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