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Legend: Boston Convention & Exhibition Center = CC, Westin Boston Waterfront = W, Seaport Boston Hotel = S
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114 * ! Mon, 8/4/2014, 8:30 AM - 10:20 AM CC-257A
Statistical Issues in Process Validation of Pharmaceutical Products — Topic Contributed Papers
Biopharmaceutical Section , Section on Physical and Engineering Sciences
Organizer(s): Katherine E.D. Giacoletti, McNeil Consumer Healthcare/Johnson & Johnson
Chair(s): Katherine E.D. Giacoletti, McNeil Consumer Healthcare/Johnson & Johnson   
8:35 AM Challenges in Inferring Statistical Results from Scale-Down to Manufacturing Scale Daniel Coleman, Genentech
8:55 AM Developing Process Performance Qualification (PPQ) Acceptance Criteria for a Large Molecule Product with Limited Data Brenda Ramirez, Amgen
9:15 AM Using the 'Science of Quality' to Develop a Process Validation Lifecycle Plan for Pharmaceutical Products Helen Strickland, GlaxoSmithKline
9:35 AM Determining the Number of Process Performance Qualification Batches Richard Lewis, GlaxoSmithKline ; Bill Henry, GlaxoSmithKline ; John Joseph Peterson, GlaxoSmithKline ; Paul McAllister, GlaxoSmithKline
9:55 AM Discussant: Stan Altan, Janssen
10:15 AM Floor Discussion



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