Overview

Using pharmacovigilance audit techniques allows a company to identify any existing gaps or risks in their systems and procedures. This allows them to define and establish priorities and company compliance.

Participants will learn how to prepare for an audit and 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.

Featured topics

PV Audits - QMS Requirements from GVP
PV Audit Universe
Building a Strategic/Tactical PV Audit Planning
Operating Individual PV Audits
PV Inspection Readiness
Management of PV Inspection
Management of Post-PV Inspection Activities

Who should attend?

Professionals most likely to benefit from this advanced course will have experience in:

or holding similar positions within the industry.
A sound knowledge of Pharmacovigilance is a must. A practical experience in audits and inspections is desirable.

Learning objectives

On completing this training course, participants will be able to:

Plan pharmacovigilance audits based on risk assessment
Identify and address the different areas of a pharmacovigilance system through audits
Design a pharmacovigilance audit
Evaluate audit documentation
Formulate communication strategies with difficult characters, situations with missing documentation and master extreme situations
Critique disagreements on audit findings
Identify and follow-up on corrective and preventive actions (CAPAs)
Prepare for a pharmacovigilance inspection

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Advanced Pharmacovigilance Audits and Inspections