Description
Sponsors, CROs, and research sites are required by regulatory authorities and GCP to have an effective process to manage significant noncompliance through corrective and preventive action (CAPA) plans. These stakeholders should have procedures to support their CAPA system and documentation. Team members must understand a CAPA process and how it links into quality risk management. This training is designed to provide this understanding and is an essential companion to training on a company specific CAPA system. It is also a foundation for the CAPA process and supports understanding through GCP industry specific case scenarios and other application exercises in each section.
