Conduct of clinical trials is a complex process and in spite of all efforts put there may still some risks not sufficiently addressed or any problems raised affecting safety of study participants or reliability of collected data.
A CAPA (corrective action, preventive action) Plan is used to address deviations, issues or problems that have already occurred and to put measures in place to avoid future deviations or problems. Such Plan is indispensable for dealing with audit and/or inspection findings as part of continuous processes improvement.
During this training you will learn the methods of root cause analysis, specifics of CAPA Plan preparation in clinical trials, how to manage CAPA Plan process and how to document it.
The training is dedicated to intermediate staff from the investigational sites, CROs, pharma or biotech companies or vendors who support clinical trials conduct. Everyone might be engaged in CAPA Plan management. Please make sure before this course you have completed Introduction to CAPA Plan course.
