69.00€
Every clinical trial is made up of multiple moving parts and everyone needs to work smoothly and consistently to deliver projects on time and meet expectations, i.e. deliver reliable study data and at the same time to protect study participants.
If a part within this machine (i.e. clinical study) breaks down, a ripple effect occurs across the entire organization, resulting in project delays and huge cost overruns but what even more important may put study participants at risk and negatively affect quality of data.
So how can we turn clinical trials into a well-oiled machine? How can we systemize your processes and ensure more consistent results?
The answer is with… standard operating procedures (SOPs) — a way to document the processes from start to finish.
During this training you will learn how to plan and prepare effective SOPs that will help in quality maintenance if improvement and work efficiency.
The training is dedicated to staff from the investigational sites, CROs, pharma or biotech companies or vendors who have already experience in clinical trials conduct and might be the process owners or might be delegated for SOP writing.
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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