• • The PV Inspection Landscape
  • Risk-Based Inspection Readiness
  • Logistics for Preparing for and Managing the Inspection
  • Documentation and Inspection Dynamics
  • Common Inspection Findings & CAPA Response
  • Embedding Continuous Inspection Readiness

• This course is designed for professionals in Global HQ roles who have governance, oversight, or operational responsibility within the pharmacovigilance system. It is particularly relevant for those in:

  • Pharmacovigilance and Drug Safety (including QPPV office functions)
  • Quality Assurance and Compliance
  • Regulatory Affairs
  • Risk Management
  • Medical Affairs
  • PV Operations and governance leads

A solid working knowledge of pharmacovigilance requirements is expected. Prior exposure to internal audits or health authority interactions is advantageous but not required.

• At the conclusion of this virtual live training course, participants will be able to:

  • Describe the inspection landscape – identify the legal basis and scope including possible sanctions for non-compliance.
  • Apply a risk-based approach to inspection readiness – use audit and self-assessment techniques to identify gaps in the PV system and prioritise remediation activities before a regulatory visit.
  • Prepare and manage inspection logistics at Global HQ – plan the inspection from notification through close-out, including documentation preparation, room management, and cross-functional coordination.
  • Evaluate and manage PV documentation under inspection conditions – assess documentation quality and completeness, and handle situations involving missing, incomplete, or disputed records.
  • Navigate complex inspection dynamics – manage communication with inspectors in challenging situations, handle disagreements on findings professionally, and maintain composure in high-pressure scenarios.
  • Identify common inspection findings – recognise findings that are frequently cited understand how to prevent and address them.
  • Develop and oversee a robust CAPA response – structure corrective and preventive actions that are credible, time-bound, and proportionate to the severity of findings, and establish follow-up mechanisms to verify effectiveness.
  • Embed inspection readiness as an ongoing practice – apply strategies to sustain a state of continuous inspection readiness across Global HQ, including documentation governance, self-inspection programmes, and quality oversight routines.