Live Training: Risks and Disadvantages of an Incorrectly Designed QMS in Pharmacovigilance

Product detailed description

A well-structured Quality Management System (QMS) is essential for ensuring compliance, efficiency, and regulatory readiness in pharmacovigilance. However, when QMS processes are inadequately designed or improperly implemented, companies face significant risks—from regulatory non-compliance and data integrity issues to inspection findings and operational inefficiencies. This webinar will provide practical insights into the most common pitfalls of a weak QMS, how to identify gaps, and best practices for building a strong, audit-ready system. 

Key Topics Covered: 

1. Regulatory Risks: How a poorly designed QMS can lead to non-compliance with GVP guidelines, fines, and regulatory warnings.
2. Operational Inefficiencies: The impact of unclear processes, lack of training, and poor documentation on pharmacovigilance activities. 
3. Inspection Readiness & CAPA Pitfalls: Common audit findings and how to avoid recurring Corrective and Preventive Actions (CAPA) failures.
4. Data Integrity & IT Challenges: The risks of poorly validated pharmacovigilance databases, missing audit trails, and system security issues. 
5. Best Practices for a Strong QMS: How to optimize processes, implement effective SOPs, and ensure continuous compliance.

Sturucture of Training: 

• 1 hour of training
• 1 hour of deep discussion on pre-defined case studies or your open discussion issues
• The training is limited to a maximum of 6 participants. Additional sessions will be scheduled if needed.

Live trainings are interactive online meetings where we provide valuable insights into key pharmacovigilance topics while ensuring a practical and engaging learning experience. Our goal is not just to present information but to create a dynamic space for knowledge sharing, where participants can gain a clear understanding of regulatory requirements, best practices, and real-world applications. Each session is designed to be concise, well-structured, and packed with actionable content to help attendees navigate complex industry challenges.

Speaker:

Richard Kodat: Pharmacovigilance auditor and strategic advisor for vendor management with more than 10 years of experience.