Preparation for a regulatory inspection is essential for all organisations and the experience of the PharmaAudit Auditors can help you. Preparation can involve several different aspects. The PharmaAudit Team can audit a specific clinical trial for you, can review training records, job descriptions and SOPs as well as providing interview training and mock-interviews.

Each Regulatory Inspection Preparation starts with a briefing for all relevant personnel. This can be followed by group Interview Preparation Training before the audits and reviews commence. This training can also be augmented with recent experiences of findings, an overview of the inspection process including categories of findings and what to expect 'on the day'. The audit can be conducted in a standard way or in a similar format to a regulatory inspection.

At the end of the time in your office or on site a meeting will be held to provide feedback and to discuss additional needs in preparation for the inspection.

Routine Audits | SOP Development | CRO Evaluation