5/13/2020
Topic: Critical Documentation of Clinical Trial Activities and CAPA During and Post COVID-19 Restrictions
When: June 2, 2020
Time: 1:00 p.m. – 2:00 p.m. EDT
Register: By clicking here
Description: During the COVID-19, crisis it has become apparent that many stakeholder’s quality systems were lacking and need additional support and flexibility. Some quality system and protocol deviations are expected due to restrictions to ensure safety during the pandemic. Quality documentation is needed for these deviations. Investigation, root cause analysis (RCA), and corrective and preventive actions (CAPA) are needed in many situations for audit readiness, but many routine audits have been put on hold or delayed due to restrictions on in-person visits. But documentation and management are needed now. Best practices for remote implementation of CAPA will be discussed.
Key take away benefits:
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
- The Clinical Pathways Team
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