Pharmacovigilance Audit GVP Auditing & Compliance

Master risk-based PV audits, GVP compliance, audit findings, CAPA, inspection readiness and practical auditing tools

What you'll learn

⚡ Understand core pharmacovigilance principles, terminology, regulatory frameworks, and the role of GVP in protecting patient safety.
⚡ Apply GVP requirements to evaluate pharmacovigilance systems, processes, documentation, compliance, and regulatory obligations
⚡ Plan and conduct risk-based pharmacovigilance audits, identify findings, assess compliance gaps, and document audit observations
⚡ Evaluate CAPA, signal management, safety reporting, risk management, training, and PV quality systems for audit readiness.

Requirements

❗ No prior pharmacovigilance or GVP auditing experience is required.
❗ A basic interest in pharmacovigilance, drug safety, patient safety, quality, or regulatory affairs is helpful.
❗ Basic knowledge of the pharmaceutical or healthcare industry is beneficial but not mandatory.
❗ No specialized software or equipment is required—learners only need a computer or mobile device with internet access.

Description

Pharmacovigilance Audit: GVP Auditing & Compliance
Develop the knowledge and practical skills needed to understand, plan, conduct, and follow up on pharmacovigilance audits in a regulated environment.
This course provides a structured, practical introduction to pharmacovigilance auditing, with particular emphasis on Good Pharmacovigilance Practices (GVP), risk-based auditing, audit planning, audit execution, classification of findings, CAPA management,and inspection readiness.
The course is designed for pharmacovigilance professionals, pharmacists, quality professionals, auditors, regulatory affairs professionals, drug safety specialists, and healthcare professionals who want to strengthen their understanding of pharmacovigilance quality systems and auditing.
What will you learn?
By the end of the course, you will be able to
✨ Understand the purpose and structure of a pharmacovigilance system
✨ Explain key GVP principles relevant to pharmacovigilance auditing
✨ Identify the responsibilities of the Marketing Authorization Holder, QPPV and other key PV stakeholders
✨ Understand the pharmacovigilance quality system and its documentation
✨ Evaluate interfaces, outsourced activities and pharmacovigilance agreements
✨ Distinguish PV audits from regulatory inspections, monitoring and self-assessments
✨ Understand different types and scopes of pharmacovigilance audits
✨ Apply risk-based principles when developing a PV audit programme
✨ Plan and prepare for a pharmacovigilance audit
✨ Conduct audit interviews and evaluate objective evidence
✨ Identify and document pharmacovigilance audit findings
✨ Classify findings as Critical, Major, or Minor
✨ Understand root cause analysis and Corrective and Preventive Actions (CAPA)
✨ Follow up on audit findings and evaluate CAPA effectiveness
✨ Support pharmacovigilance inspection readiness
Practical learning
This course goes beyond theory. You will be introduced to practicalPV audit checklists, templates, and auditor tools that show how auditing principles apply to real pharmacovigilance activities.
Realistic examples and audit scenarios are incorporated throughout the course to help you develop an auditor's approach to evaluating compliance, identifying weaknesses and documenting meaningful findings.
Who should take this course?
This course is suitable for
✨ Pharmacovigilance and Drug Safety professionals
✨ QPPVs, LQPPVs and local PV representatives
✨ Pharmacovigilance auditors
✨ Quality Assurance professionals
✨ Pharmacists
✨ Regulatory Affairs professionals
✨ PV Compliance and Governance professionals
✨ Medical and pharmaceutical professionals
✨ Professionals preparing for PV audits or regulatory inspections
✨ Anyone seeking practical knowledge of GVP auditing
No previous auditing experience is required. Basic knowledge of pharmacovigilance is helpful, but the course introduces the essential concepts before progressing to more advanced auditing topics.
Build a practical understanding of pharmacovigilance auditing and learn how to evaluate PV systems systematically, identify compliance gaps, and contribute to continuous improvement and inspection readiness.

Who this course is for

⭐ Pharmacovigilance and Drug Safety Professionals who want to strengthen their knowledge of GVP requirements, PV quality systems, compliance, and auditing.
⭐ QPPVs, LQPPVs, LPPVs, and Local Safety Officers seeking practical knowledge of audit readiness, regulatory compliance, CAPA, and PV system oversight.
⭐ Pharmacists, physicians, nurses, and other healthcare professionals interested in developing their careers in pharmacovigilance, drug safety, patient safety, or quality assurance.
⭐ PV Managers, Consultants, and Pharmaceutical Industry Professionals who want to refresh or expand their understanding of GVP compliance, risk management, safety reporting, signal management, and inspection/audit preparedness.

Homepage

https://www.udemy.com/course/pharmacovigilance-audit-gvp-auditing-compliance

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