PV AUDIT & INSPECTION READINESS

PV Audit & Inspection Readiness

Pharmacovigilance (PV) professionals are expected not only to process safety data but also to ensure continuous compliance with global regulatory requirements. Health authorities such as the FDA, EMA, MHRA, and Health Canada routinely conduct audits and inspections to evaluate a company’s PV system, processes, and compliance with GVP standards.

The PV Audit & Inspection Readiness (PVIR) program equips learners with the knowledge, tools, and confidence to prepare for, manage, and respond effectively to pharmacovigilance audits and inspections. This program emphasizes regulatory frameworks, documentation practices, mock audit preparation, and inspection communication skills, ensuring professionals are always inspection-ready.

SIP – Self-Paced Online with Support

1. Course Duration: 3 weeks (80 hours)
2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, simulations, mock inspection tasks).

   By the end of this course, learners will:

2. Understand regulatory expectations for PV audits and inspections (FDA, EMA, MHRA, ICH-GVP).
3. Learn the types of audits (internal, external, vendor, regulatory) and inspection triggers.
4. Prepare and maintain essential PV documentation (SOPs, PSMF, TMF, safety reports, training logs).
5. Identify common audit findings and implement corrective and preventive actions (CAPA).
6. Participate in mock audits and readiness assessments to test compliance.
7. Build effective skills for inspection conduct – responding to questions, presenting evidence, and ensuring transparency.
8. Develop strategies for post-inspection follow-up and compliance sustainability.

This program is ideal for:

1. Drug Safety / PV Associates and Specialists responsible for compliance and documentation
2. Regulatory Affairs professionals preparing for authority inspections
3. Quality Assurance teams supporting PV audits and SOP management
4. CRO and Pharma staff seeking inspection readiness skills

Learners should have prior exposure to pharmacovigilance processes, adverse event reporting, and regulatory compliance concepts. Basic knowledge of PV databases, safety documentation, and SOPs is recommended.

1. Gain practical strategies to prepare for audits and inspections.
2. Learn how to maintain audit-ready PV systems and documentation.
3. Build confidence in responding to inspectors and auditors.
4. Understand how to manage findings, CAPAs, and follow-up actions.
5. Position yourself for roles such as PV Compliance Specialist, Audit Coordinator, or QA-PV Manager.

This program is aligned with:

1. EMA GVP Module I & Module II (PSMF requirements)
2. FDA PV inspection guidance
3. MHRA Good Pharmacovigilance Practice requirements
4. ICH-GVP global guidelines

1. PV Compliance Associate / Specialist
2. PV Quality & Training Coordinator
3. Audit & Inspection Readiness Specialist
4. Regulatory Compliance Manager (Pharma / CRO)
5. Pharmacovigilance System Auditor

For more information, please call us at +91 8925971788 / +91 8977943100 (WhatsApp)or email qpdc@qtechelearncenter.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.