• 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

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:

• Focus
• Flexibility
• Convenience
• Cost Effectiveness

For more information please contact Basel@DIAglobal.org