Advanced Pharmacovigilance Auditing
You will learn how to prepare for an audit and an inspection in order to achieve best practices from the moment of facing the auditing/inspection visit notification to the moment of receiving the report and its conclusions.
What you will learn
- Global PV processes
- Reconciliation process, clinical and/or spontaneous
- Safety data exchange agreements (SDEA)
- Contractors (audit selection and audit in the process)
- System and process audits
- PSMF audits
- Computerised systems audits
- Audits of affiliates and third parties
- Audits as preparation for a PV inspection
- Preparing and going through a pharmacovigilance inspection
Who should attend?
Professionals most likely to benefit from this training have experience in pharmacovigilance, drug safety, regulatory affairs, quality assurance, risk management, medical affairs or similar positions within the pharmaceutical industry.
At the conclusion of this course, participants will be able to:
Make a PV audit based on risk assessment
Cover the different areas through system audit
Perform a process audit
Interview and review audit documentation
Deal with difficult characters, missing documentation, and extreme situations
Manage disagreements on audit findings
Review and follow-up on CAPAs
Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.
Plan Your Team's Professional Development
Why not take advantage and train your whole department (or even across different departments!) and benefit from increased:
- Cost Effectiveness
For more information please contact EMEA@DIAglobal.org