Agenda
8:30 AM — 9:00 AM
9:00 AM — 10:30 AM
Session 1: THE BASICS10:30 AM — 11:00 AM
11:00 AM — 12:30 PM
Session 2: EUROPEAN AND FDA INSPECTIONS12:30 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 3: PHARMACOVIGILANCE REQUIREMENTS AND FINDINGS3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 4: RESPONDING TO THE FINDINGS AND PREPARING THE CAPA5:00 PM — 6:00 PM
8:30 AM — 10:00 AM
Session 5: ONSITE AUDIT / INSPECTION10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 6: PREPARATION FOR AUDITS AND INSPECTIONS12:00 PM — 12:15 PM
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