This course provides a brief overview of the CAPA life cycle, roles and responsibilities, implementation, verification, effectiveness check. Regulatory consequences of incomplete CAPA management (483s, WLs) will also be addressed.
Subject area:
cGMP
Objectives (If applicable):
•Describe challenges associated with CAPA implementation and effectiveness.
•Identify and explain regulatory consequences of incomplete CAPA management (483s, WLs)
•Summarize the roles and responsibilities, effectiveness of implementation of CAPA and verification processes.
Target Audience (If applicable):
QA Manager
QA Staff
QC Chemist
QC Manager
Regulatory