José Ortiz will be participating as a trainer together with Wendy Huisman in the Pharmacovigilance Quality Management System course organized by DIA. The training will be delivered online from 1:30 PM to 6:00 PM (CEST).
The course will employ a mix of informative sessions, real case studies, and hands-on interactive exercises where attendees will be able to apply what they have learned. Learners will leave the course with an understanding of how elements of the Pharmacovigilance and Quality Management Systems fit together to achieve regulatory compliance.
- Quality and the Quality System
- QMS Overview
- PV System
- System, Processes, Quality Documents
- PSMF and PV Quality Manual
- Risk Assessment of Identified Gaps
- Procedures and Standards
- PV in the Clinical Study and Clinical Trial Environment
- PV Agreements and PV Provisions
- Commercial Activities and PV Obligations
- Compliance Management and Monitoring
- Risk-Based Auditing and the PV Audit Universe
- Record Management and Documentation of QMS
- PV Inspections and Inspection Readiness
- Responding to Inspection and Audit Findings
- CAPA Plan
Interested in joining?
The complete training program can be found at this link: