Description
Pharmacovigilance (PV) inspections and audits are essential for ensuring that pharmaceutical companies comply with the regulations and guidelines related to drug safety. This course provides an in-depth understanding of the PV inspection and audit process, including the relevant regulations, guidelines, and standards. Participants will learn about the roles and responsibilities of different stakeholders in PV inspections and audits, including regulatory authorities, auditors, and the pharmaceutical industry. The course also covers the key elements of a successful PV inspection and audit, such as documentation, data collection and analysis, risk management, and corrective and preventive actions.