69.00€
Is the audit or inspection closed just after the closing meeting? The correct answer is: NO.
There is number of activities that needs to be done after the audit/inspection. One of them is review of the identified findings which are listed in the audit/inspection report.
During this training you will learn what to expect from the report, what the findings are and how they can be categorized. We will also try to play the auditor/inspector role and make the attempt to categorize some of the findings cited by auditors or competent authorities inspectors.
The training is dedicated to inexperienced or less experienced staff from the investigational sites, CROs, pharma or biotech companies or vendors who support clinical trials conduct.
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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