Pharmacovigilance Auditing and Inspections Training

Pharmacovigilance Online Courses with Certificate & Pharmacovigilance Auditing and Inspections Course Description

Advance your expertise in pharmacovigilance compliance with this practical 2026-focused PV Audit Strategy Planning training designed for pharmaceutical, biotech, and life sciences professionals. This course provides a clear understanding of current FDA and European Medicines Agency (EMA) expectations for risk-based pharmacovigilance audits, GVP Module IV compliance, inspection readiness, and PV quality system oversight.

Participants will learn how to develop and implement an effective risk-based PV audit strategy, define the PV audit universe, assess high-risk PV processes, manage third-party oversight, and strengthen compliance across global pharmacovigilance operations. The training also covers current industry expectations for remote audits, CAPA effectiveness, data integrity, vendor management, and audit planning in evolving regulatory environments.

This interactive workshop is ideal for pharmacovigilance, QA, compliance, regulatory affairs, and drug safety professionals seeking practical strategies to improve PV audit readiness, reduce compliance risk, and maintain effective global pharmacovigilance quality systems through expert-led Drug Safety training programs.

Agenda – Day 1

Introduction & Global Pharmacovigilance Regulatory Framework

• Introductions & course objectives
• ICH Guidelines – US, EU & Japan regulatory expectations
• ICH Q10 – Pharmaceutical Quality System
• Product lifecycle management
• Quality system monitoring resources
• ICH Q9 – Quality Risk Management
• Risk management methodologies, tools & frameworks
• ICH E2 – Clinical Safety Data Management
• 21 CFR Part 314.80/81 pharmacovigilance requirements
• European Medicines Agency GVP Module IV (R1) – Risk-Based PV Audits

Designing a Risk-Based PV Audit Strategy

• Risk-based audit approach for global PV systems
• Strategic audit planning (2–5 year approach)
• Tactical & operational audit planning
• Defining the Pharmacovigilance Audit Universe
• Prioritizing audits using risk assessment models

Pharmacovigilance System Master File (PSMF)

• GVP Module II – PSMF requirements
• PV Quality Management System (QMS) oversight
• Annex G expectations:
• Audit schedules
• Completed audits & tracking
• Significant CAPAs & effectiveness monitoring
• Designing an effective PV QA Programme

Oversight of PV Operations & Third Parties

• Audit coverage for:
• Internal PV activities
• Affiliates & global partners
• Vendors & outsourced PV providers
• Cross-functional interactions (GMP, Regulatory Affairs, Quality)
• Service Level Agreements (SLAs)
• Safety Data Exchange Agreements (SDEAs)
• KPI/KQI monitoring for PV compliance oversight

Modern PV Compliance Challenges in 2026

• Remote & hybrid PV audits and inspections
• Risk-based vendor oversight models
• Data integrity expectations in PV audits
• Audit trail review & inspection readiness
• Emerging trends in AI-enabled PV systems oversight

Operational Audit Readiness

• Tactical & operational audit preparation
• Pre-audit questionnaires & readiness tools
• Audit planning documentation

Interactive Workshop & Case Study

• Practical Exercise: Designing a PV QA Audit Programme
• Risk assessment workshop
• Group discussion & Q&A session

Agenda – Day 2

Q&A Session & Day 1 Recap

• Key takeaways and expert discussion

Pharmacovigilance Inspections & Regulatory Expectations

• GVP Module III – PV Inspections
• EMA remote & hybrid inspection expectations
• MHRA guidance on remote inspections
• Routine, pre-authorisation & for-cause inspections
• Current FDA & EMA inspection focus areas

Inspection Readiness & Audit Management

• Preparing for pharmacovigilance inspections
• Inspection planning tools & checklists
• Document request management
• Inspection metrics & regulatory trends
• Maintaining continuous inspection readiness

CAPA Effectiveness & Audit Findings

• Developing SMART CAPAs
• Root cause analysis & corrective action planning
• Managing critical, major & minor findings
• CAPA effectiveness verification
• Questions to consider during inspections & audits

Advanced Case Studies & Practical Exercises

• Case Study 1 – Risk-Based Audit Findings
• Case Study 2 – PV Inspection Readiness
• Case Study 3 – CAPA & Compliance Challenges
• Interactive Q&A and expert discussion

Course Completion

• Final Q&A Session
• Certificate of Completion – Advanced Pharmacovigilance Auditing & Inspections Virtual Training Program

Learning Objectives

Upon completing of this course, participants should be able to:

• Understand the legal requirements and health authority expectations for a risk-based audit program and current interpretation. Plan, develop and implement the PV Audit Strategy Plan, which includes the following processes:
• Develop a high-level PV audit strategy
• Identify the PV activities and processes subject to PV audit
• Develop risk assessment criteria
• Identify the PV audit universe – entities subject to PV audit
• Categorize the entities subject to PV audit
• Perform risk assessments
• Prioritize entities for audit according to relative risk
• Prepare a 3–5-year PV audit plan
• Identify procedures/tools to monitor PV quality of third parties

Who Will Benefit

This course is designed for people with some PV experience and tasked with developing, maintaining, updating and/or reviewing the PV quality system audit strategy plan, risk assessment and/or the annual PV audit schedules. It is also beneficial for staff responsible for the quality oversight of third parties conducting PV activities.

The following personnel will benefit from the course:

• PV Quality Assurance Staff
• PV Compliance professionals
• Quality auditors
• Pharmacovigilance Auditors
• Relevant Pharmacovigilance Staff
• PV Service Provider Relationship Managers
• MAH Affiliates responsible for Pharmacovigilance