69.00€
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.
Agnieszka is graduated from Faculty of Biology, University of Warsaw, where she also had continued research study earning PhD in Molecular Biology. Mastering the knowledge in life science field and developing transferable skills helped her in clinical research field. Currently, she is a GCP Expert with over 15 years of experience in clinical research as a Contract Research Associate, Trainer and Clinical Quality Manager. Responsible for inspection readiness activities, inspection preparation, facilitation and follow up. Participated in several on-site or remote FDA, EMA and local Health Authority inspections as well as in number of audits when working for CROs or pharmaceutical companies. Actively involved in in-dept root cause analysis of the audit or inspections findings, effective CAPA plans preparation, their follow up and effectiveness check.
Agnieszka is process-oriented, especially in terms of the processes at the site level, as she believes that a good set up of the investigational site for clinical trial is indispensable to its success.
As a member Training Section of the Association for Good Clinical Practice in Poland (GCPpl), she promotes knowledge about clinical trials and ICH GCP in the medical and pharmaceutical industries and likes sharing experience with others.
Don’t miss out on this opportunity to revolutionize your employee development process with AIDIFY’s freemium license. Fill out our form to get started today!
Reviews
There are no reviews yet.