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Course Agenda
Day One (11:00 AM - 5:00PM) EST
11:00 – 12:00 PM: Lecture 1: Moving a Product out of R&D
12:00 PM – 1:00 PM: Lecture 2: CMC Requirements for an IND Study
1:00 – 1.30 PM: Break 1:30 – 3:30 PM: Lecture 3: GMPs for Phase 1 IND Products
3:30 – 3.45 PM: Break 3:45 – 5:0 0PM: Lecture 4: Raw Material Management
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Day Two (11:00 AM - 5:00PM) EST
11:00 – 12:00 PM: Lecture 5: Process Validation in Early Stage GMP
12:00 PM – 1:00 PM: Lecture 6: GMPs for Early Stage Medical Devices: QSR and GMP
1:00 – 1.30 PM: Break 1:30 – 3:30 PM: Lecture 7: Clinical Trials with Early Stage Products
3:30 – 3.45 PM: Break 3:45 – 5:0 0PM: Lecture 8: Outsourcing Early Stage Manufacturing
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