RA/QA Quarterly Event: How to Survive a Surprise FDA Audit
August 23, 2016 @ 5:30 PM - 7:00 PM
PSC Biotech presents “How to Survive a Surprise FDA Audit”
FDA shows up at your door, what do you do next? Attila Ari from PSC Software, will provide an overview of how to prepare for just such an event. The goal of any inspection, whether governmental agency of customer is to provide the information they seek in a timely and orderly manner, because as much as we love them, in this instance, we’re happier to see them go away happy with our organization.
Review the items that need to be in place prior to an audit
What to expect during the opening meeting and how to control the audit to your advantage
Practices to implement during the audit and those that need to be avoided