The "Webinar on GCP Auditors' Insights on Current Clinical Trial Environment 2023" recording provides a comprehensive discussion on the common audit and inspection findings related to clinical trials across different regions and regulatory agencies.

The panelists, who have extensive experience in the field, delve into recent case studies of audit and inspection findings, highlighting the corrective and preventive actions taken to address these issues and mitigate future findings.

The webinar offers valuable insights into the recently updated regulations and guidelines in the clinical trial space and explores their potential impact on audit and inspection findings focusing on topics such as risk-based monitoring, source documents, EMA critical and major findings, Form FDA 1572, and decentralized clinical trials. Attendees will gain a deeper understanding of the changing regulatory expectations and learn best practices for maintaining clinical trial quality assurance.

The webinar features panelists from Europe, the USA, and Africa, ensuring a diverse perspective and allowing attendees to engage in open discussions and Q&A sessions. The discussion starts with an introduction, providing an overview of the topics to be covered. The webinar then proceeds with insights into the inspection finding trends of the MHRA, EMA, and FDA.

The panelists share their knowledge on common audit issues and shed light on a case where an FDA inspection led to legal consequences. The 530/2014 EU Clinical Trial Regulation is also discussed, introducing attendees to its implications and requirements. The recording concludes with an examination of ICH GCP (R3), the upcoming revision.