Pharmacovigilance QMS & Inspection Preparation Training Course

This two-day course provides a practical and comprehensive understanding of pharmacovigilance Quality Management Systems (QMS) and inspection readiness, reflecting the increasing regulatory focus on risk-based auditing and continuous improvement.

Designed to support organisations in meeting evolving EU requirements, the course explores how effective QMS frameworks underpin compliance across the entire business from pharmacovigilance and clinical teams to regulatory, IT, and senior leadership. It highlights how companies can design, implement, and maintain robust systems that stand up to regulatory scrutiny while driving ongoing quality improvements.

Participants will gain insight into the full audit and inspection lifecycle, including risk-based planning, execution, reporting, and follow-up activities. The course also places strong emphasis on the development and management of Corrective and Preventive Actions (CAPAs), ensuring issues are properly investigated, addressed, and prevented from recurring.

With a highly interactive approach, combining expert guidance, real-world case studies, and hands-on workshop sessions, this training equips attendees with the practical skills and confidence to manage audits, prepare for inspections, and strengthen QMS processes within their organisation.