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