Do you feel fear or stress when hearing the word “audit” or “inspection”? Are you afraid that you start panicking when the audit or inspection will be announced in your study? You have never participated in audit or inspection, yet? Data filing to regulatory authorities in your study is approaching? If so, the training is for you.
This basic training course will help you to understand what GCP audits and inspections are, what are their purposes, similarities and differences and how to be ready for them. We will also go through the whole audit and inspection process so you will be made aware what to expect during the audit/inspection, how to interact with the auditor or inspector, how to prepare requested documentation and what must be done next. This will help you to go smoothly through the audit or inspection and enable you to concentrate on them as on the learning opportunity which will extend your expertise in clinical trials and support you in continues improvement of yourself but also the clinical trial related processes you are or you will be involved in.
You will also familiarize yourself with some examples of the most common inspection findings and you will get some tips how to minimize the risk of their occurrence. In other words, you will know how to be inspection ready at any time.
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.
