69.00€
Quality Management System frameworks have existed across different industries, from aviation to car manufacturing, for years. But it’s actually only the past decade or so that they have been introduced in clinical trials to improve trial speed, efficacy and quality.
QMS in clinical trials often begins with the simple things – for example compiling best practices together into unified documents system. It is sufficient to improve staff confidence (people know what to do and how). If you add regular managerial meeting and review, accountability and continued improvement than your QMS will expand.
During this training you will learn the basics about QMS and QMS in clinical trials: definitions, structure and benefits. There will be also examples presented of the gaps in QMS and their consequences.
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 is part of QMS, if such is developed.
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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