ARTICLE REFERENCE: How to survive an FDA audit by Paul Dupont
The arrival of an audit inspection can instill feelings of fear and anxiety that can be duly diffused with the right preparation and mentality.
We’ve compiled a few concise pointers to help see you through the process.
Keep your employees in the loop
Identify several key members of personnel to liaise with the investigator during the audit process, and make them aware of their role. Prepare them as best as possible, so that they are in line with your organisation’s approach to the audit.
Do your research
Spend some time to familiarise yourself with the regulations, to make sure that your daily processes conform to the required standard.
Keep an open mind
Try not to be overly defensive in response to the investigator’s criticisms. Think clearly, and discuss the issue at hand openly. ‘You’re more likely to respond to…
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