How to Prepare for Pharmacovigilance Audits and Inspections

Every pharmacovigilance function will, at one time or another, undergo governmental or health authority inspections as well as audits by license partners, internal auditors and others. The course will teach you how to prepare for an audit / inspection from the time of the receipt of the announcement (or of the arrival of the inspectors at your doorstep) to the conclusion of the audit or inspection.

Professionals who work in:

• Pharmacovigilance / Drug safety (QPPV)
• Regulatory Affairs
• Quality & Compliance
• Information Technology
• Medical Information
• Risk Management
• Compliance
• Pharmacovigilance Auditors
• Management Staff Responsible for Running Inspections
• Employees (directly and indirectly) Involved in Inspections

COURSE LEVEL
For professionals with 2-3 years of experience in pharmacovigilance this course will be at an intermediate level; professionals with experience from the auditing area will find this course to be at a beginner level.

At the conclusion of this course, participants should be able to:

• Participate in audits / inspections and mock audits / inspections
• Assess how to handle the actual audit / inspection and responses to requests and findings based on the
• understanding of audit / inspection methodology
• the legal basis of inspections or
• the contractual basis of audits and
• the appreciation of regional differences
• Prepare responses to audit / inspection findings, including responses and corrective/preventive action (CAPA) plans
• Prepare their function for an audit / inspection: roadmap, teams, tasks, and documents
• Assess regional differences with respect to European and US FDA inspections