The recent COVID-19 outbreak has disrupted clinical trials drastically. Many stakeholder’s quality systems did not have the agility to fully perform during this crisis. As a result, multiple QC and QA activities were cancelled or delayed. Deviations have occurred with clinical trial protocols – some justified – to maintain the safety of trial subjects and critical data quality attributes linked to safety. Furthermore, some project plan and protocol deviations could be caused by other factors but still do not meet the criteria described in regulatory authority guidances (e.g., FDA and EMA). Ensuring solid CAPA and root cause analysis is essential for audit readiness, as COVID-19 has put unexpected stress on the systems that the industry has in place to maintain quality.
This course discusses the need for quality documentation of events that occurred during the crisis that are linked to significant risks and issues that matter. You will review important actions and documentation between various stakeholders (read: sites and sponsors, CROs and sponsors, etc.) which must happen to ensure deviation identification, root cause analysis (RCA), and Corrective and Preventative Actions (CAPA) are handled in a compliant fashion. Best practices for remote implementation of these activities will be discussed. This course will also provide guidance to conduct “renovations” to your existing quality systems to ensure oversight and adequate monitoring and quality conduct of your trial. In the end, we can come out of this with a healthier and more agile quality system and a more responsive industry. The timing could not be better as we approach another revision of ICH E6 (R3)!
Attend this interactive live session and you will be able to:
- Describe what warrants a CAPA
- Discuss the impact of COVID-19 on CAPA and critical documentation during and after COVID-19
- Recognize the elements in a quality management system (QMS) that were most stressed and need to be updated to support agility for efficiencies and compliance
- Strategies to ensure audit readiness for all