69.00€
Today, clinical trial professionals are provided with guidelines, regulations, company policies, procedures, and endless amounts of training to help them with the conduct of clinical trials.
Despite all the training one receives or all the guidelines, regulations, company policies, and procedures in place to assist with the conduct of a clinical-trial, problems including unanticipated situations or safety issues may arise.
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.
During this training you will learn the basics regarding CAPA: CAPA definitions and requirements, CAPA Process and CAPA Plan Management.
The training is dedicated to less experienced 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. For more information please refer to the course Preparation of CAPA Plan.
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.
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