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Advanced Pharmacovigilance Auditing

You will learn how to prepare for the audit inspection in order to achieve best practices from the moment of facing the auditing visit notification to the moment of receiving the results and conclusions.


Overview

Through Pharmacovigilance Audit a company can identify the gaps or risks existing in the system and establish priorities in ensuring brand protection and company compliance.

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.

 

Learning objectives

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 EMEA@DIAglobal.org

Contact us



Registration Questions

Send Email
+41 61 225 51 51


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Send Email
+41 61 225 51 55