Live Training: Audit & self-inspection according to GVP

Product detailed description

Ensuring compliance with GVP is a critical aspect of maintaining a high-quality pharmacovigilance system. Audits and self-inspections are essential tools for identifying weaknesses, improving processes, and demonstrating regulatory compliance. This live training provides a practical, guided approach to conducting effective audits and self-inspections, helping you understand common pitfalls, regulatory expectations, and best practices for ensuring a robust pharmacovigilance system.

Key topics: 

1. Lack of Risk-Based Audit Planning: Without a risk-based approach, critical areas with compliance risks may be overlooked, leading to regulatory findings or undetected safety issues. 
2. Insufficient Documentation & Audit Trails: Missing, incomplete, out-dated or inconsistent records can lead to major findings during regulatory inspections, potentially resulting in fines, warnings, or even suspension of marketing authorization. 
3. Failure to Identify & Correct Non-Compliance Issues: Ineffective Corrective and Preventive Actions (CAPAs) mean that systemic issues remain unresolved, leading to repeat findings in future audits or inspections. 
4. Inadequate Auditor Competency & Independence: Auditors need specialized knowledge of pharmacovigilance and GVP regulations to identify critical gaps and provide meaningful recommendations. 

Structure of the 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 challenge.

Speaker:

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