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.

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Participant Testimonials

Calin was extremely informed and gave us absolutely useful practical tips and examples that are memorable enough to avoid bad behaviour during an audit/inspection.

Wonderful sessions, very relevant topics and practical suggestions.

I really enjoyed learning from an expert who could illustrate the theory with many real life cases and explain or clarify when questions were asked.

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:
- Pharmacovigilance
- Drug Safety
- Regulatory Affairs
- Quality Assurance
- Risk Management
- Medical Affairs
- 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

At the conclusion of this 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
- Conduct a pharmacovigilance audit
- Evaluate audit documentation
- Manage communication with difficult characters, situations with missing documentation and master extreme situations
- Handle disagreements on audit findings
- Identify and follow-up on corrective and preventive actions (CAPAs)
- Host and manage a pharmacovigilance inspection

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Advanced Pharmacovigilance Audits and Inspections