October 6 Alternatives for Content Uniformity Acceptance Criteria and Stratified Sampling 10:30 AM 12:15 Moderators: – PM Geoffrey Wu, FDA and Lisa Tan, GPhA Speakers: Jon Clark, USP James Drennen, Duquesne University Alex Viehmman, FDA October 6 The Science of Tech Transfer/Scale-up 1:15 5:00 PM Moderators: – Grace McNally, FDA and Ilgaz Akseli, Boehringer-Ingelheim Speakers: Implementing Fundamental Pharmaceutical Science and Materials/Engineer Expertise in Scale-Up - Ecevit Bilgili, New Jersey Institute of Technology Stephen Conway, Merck Alberto Cuitino, Rutgers University Mitigating Product Risk in Manufacturing or During Formulation Development and Identify Opportunities to Maximize Efficiency -Ilgaz Akseli, Boehringer Ingelheim San Kiang, Independent Consultant Manufacturing, Risk Management and Quality Assurance October 5 How to Prevent, Detect, and Respond to Data Integrity Events 10:30 AM 12:15 Moderators: Paula Katz, FDA and Joseph Famulare, Genentech – PM Speakers: Paula Katz, FDA Building Business Processes that Optimize Accurate and Reliable Data - Monica Cahilly, Mountain Quality Assurance Benefits of Combining Quality Risk Management (Q9) with Pharmaceutical Quality System - Joseph Famulare, Genentech October 5 Continuous Manufacturing 1:15 5:00 PM Moderators: – Thomas O’Connor, FDA and Diane Zezza, Novartis Speakers: Scientific Considerations for the Assessment of Continuous Manufacturing Processes - Thomas O’Connor, FDA Yanxi Tan Cain, Novartis cGMP and Regulatory Considerations for Continuous Manufacturing Processes - Patric Klotzbuecher, FDA Hayden Thomas, Vertex Quality and Regulatory Considerations for Continuous API: A Case - Douglas Mans, GlaxoSmithKline
October 6 10:30 AM – 12:15 PM Alternatives for Content Uniformity Acceptance Criteria and Stratified Sampling Moderators: Geoffrey Wu, FDA and Lisa Tan, GPhA Speakers: Jon Clark, USP James Drennen, Duquesne University Alex Viehmman, FDA October 6 1:15 – 5:00 PM The Science of Tech Transfer/Scale-up Moderators: Grace McNally, FDA and Ilgaz Akseli, Boehringer-Ingelheim Speakers: Implementing Fundamental Pharmaceutical Science and Materials/Engineer Expertise in Scale-Up - Ecevit Bilgili, New Jersey Institute of Technology Stephen Conway, Merck Alberto Cuitino, Rutgers University Mitigating Product Risk in Manufacturing or During Formulation Development and Identify Opportunities to Maximize Efficiency -Ilgaz Akseli, Boehringer Ingelheim San Kiang, Independent Consultant Manufacturing, Risk Management and Quality Assurance October 5 10:30 AM – 12:15 PM How to Prevent, Detect, and Respond to Data Integrity Events Moderators: Paula Katz, FDA and Joseph Famulare, Genentech Speakers: Paula Katz, FDA Building Business Processes that Optimize Accurate and Reliable Data - Monica Cahilly, Mountain Quality Assurance Benefits of Combining Quality Risk Management (Q9) with Pharmaceutical Quality System - Joseph Famulare, Genentech October 5 1:15 – 5:00 PM Continuous Manufacturing Moderators: Thomas O’Connor, FDA and Diane Zezza, Novartis Speakers: Scientific Considerations for the Assessment of Continuous Manufacturing Processes - Thomas O’Connor, FDA Yanxi Tan Cain, Novartis cGMP and Regulatory Considerations for Continuous Manufacturing Processes - Patric Klotzbuecher, FDA Hayden Thomas, Vertex Quality and Regulatory Considerations for Continuous API: A Case - Douglas Mans, GlaxoSmithKline
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