Overview Detailed Agenda Speaker Price/Registration
Course Agenda
Day One (8:30 AM - 3:30PM) EST
8:30 – 10:30 AM: Lecture 1: Moving a Product out of R&D
10:30 – 10:45 AM: Break 10:45 – 12:00 noon: Lecture 2: CMC Requirements for an IND Study
12:00 – 12:45 PM: Lunch 12:45 – 2:15 PM: Lecture 3: GMPs for Phase 1 IND Products
2:15 – 2:30PM: Break 2:30 – 3:30PM: Lecture 4: Raw Material Management
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Day Two (8:30 AM - 3:30PM) EST
8:30 – 10:00 AM: Lecture 5: Process Validation in Early Stage GMP
10:15 – 10:15 AM: Break 10:15 – 12:00 noon: Lecture 6: GMPs for Early Stage Medical Devices: QSR and GMP
12:00 – 12:45 PM: Lunch 12:45 – 2:15 PM: Lecture 7: Clinical Trials with Early Stage Products
2:15 – 2:30 PM: Break 2:30 – 3:30 PM: Lecture 8: Outsourcing Early Stage Manufacturing
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