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.
