69.00€
Once the audit or inspection is finished there is one more important activity to be done: providing response to the auditor/inspector.
During this training you will learn how to analyse the report and how to prepare the reply, including corrective and preventive actions, to be successful. We will also check what might be the consequences of unsatisfactory response to the inspection report response based on FDA 483 and Warning Letters.
The training is dedicated to intermediate staff from the investigational sites, CROs, pharma or biotech companies or vendors who support clinical trials conduct and might be involved in audit/inspection report response preparation.
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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