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Pharmacovigilance (PV) audits and inspections must be conducted independently by business partners, audit partners, separate internal quality functions within a Marketing Authorisation Holder’s (MAHs) structure, and/or regulatory authorities to examine compliance with legal and ethical standards. They are a critical and continuous element of pharmacovigilance operations, and the outcomes from failure or significant issues can be serious for both patient safety and business. This is why pharmaceutical companies must always have a range of quality system related things in place ‘ready for audit or inspection’, at all times.‘ready for audit or inspection’, at all times.
The process of ensuring readiness includes a comprehensive review of the pharmacovigilance system in place. This must include the experience and training of relevant personnel, procedures and documentation, the technology and data systems being used, and the data itself, to identify and address potential compliance gaps. With regulatory requirements continually evolving, so too are the requirements for effective audit and inspection readiness.
Preparation Strategies: Detailed training on developing effective preparation strategies for audits and inspections, including timeline planning, resource allocation, and prioritization of activities.
Role-Specific Training: Tailored training sessions ensuring that each team member understands their specific role and responsibilities in the audit and inspection process, facilitating a cohesive and effective approach to audit readiness.
Understanding Regulatory Requirements: Comprehensive overview of global regulatory requirements for pharmacovigilance, focusing on key legislation and guidelines from bodies like the EMA, FDA, and ICH.
Documentation and Data Management: Guidance on organising and managing essential documents and data to ensure easy access and review during an audit or inspection. This includes training on electronic document management systems (EDMS) and data integrity practices.
Risk Management and Mitigation: Techniques for identifying, assessing, and mitigating risks that could impact audit outcomes, including risk-based approaches to audit and inspection readiness.
Mock Audits and Inspections: Conducting simulated audits and inspections to provide hands-on experience, helping participants understand the audit process, identify potential gaps, and practice responding to auditor inquiries
Response Preparation: Training on preparing responses to potential findings, including corrective and preventive action (CAPA) plans, to efficiently address issues raised during audits or inspections.
Our Audit/Inspection Readiness instructors have years of first-hand experience with regulatory audits and inspections, as both auditor and auditee, giving an expert perspective from both sides of the process, and offering invaluable practical advice.
And through our world leading iViReg Regulatory Intelligence system, we can provide the latest regulatory information and insights for over 90 countries, so you are fully prepared for any audit and inspection challenges.
We tailor our training programs to meet the specific needs of your organization and specific audits/inspections, ensuring relevance and applicability to your operational environment.
iVigee has a focus on global regulatory requirements, and our training prepares your team for audits and inspections in any jurisdiction to ensure your organisation's compliance worldwide.