アジェンダ
9:00 AM — 9:30 AM
Welcome and Introduction9:30 AM — 10:15 AM
Session 1: Quality and the Quality System10:15 AM — 11:00 AM
Session 2: Quality Management System Overview11:00 AM — 11:15 AM
11:15 AM — 12:00 PM
Session 3: The Pharmacovigilance System12:00 PM — 1:00 PM
Session 4: Systems, Processes, Quality Documents1:00 PM — 1:15 PM
Wrap-up and Questions9:00 AM — 9:15 AM
Welcome and Recap of Part 110:15 AM — 11:00 AM
Session 6: Risk Assessment of Identified Gaps11:00 AM — 11:15 PM
11:15 AM — 12:15 PM
Session 7: Procedures and Standards12:15 PM — 1:15 PM
Session 8: Pharmacovigilance in the Study and Clinical Trial Environment1:15 PM — 1:30 PM
Wrap-up and Questions9:00 AM — 9:15 AM
Welcome and Recap of Part 29:15 AM — 10:00 AM
Session 9: Pharmacovigilance Agreements (PVAs) and PV Provisions10:00 AM — 10:45 AM
Session 10: Commercial Activities and PV Obligations10:45 AM — 11:00 AM
11:00 AM — 11:45 AM
Session 11: Compliance Management and Monitoring11:45 AM — 1:00 PM
Session 12: Risk-Based Auditing and the Pharmacovigilance Audit Universe1:00 PM — 1:15 PM
Wrap-up and Questions9:00 AM — 9:15 AM
Welcome and Recap of Part 39:15 AM — 10:00 AM
Session 13: Record Management and Documentation of QMS10:00 AM — 10:45 AM
Session 14: Pharmacovigilance Inspections and Inspection Readiness10:45 AM — 11:00 AM
11:00 AM — 12:00 PM
Session 15: Responding to Inspection and Audit Findings12:00 PM — 1:00 PM
Session 16: Corrective and Preventive Action (CAPA) Plan1:00 PM — 1:15 PM
Session 17: Pharmacovigilance QMS Course Summary and Q & A