Take-Home Checklist: The Most Important Tasks to Be Completed

Take-Home Checklist: The Most Important Tasks to Be Completed Two Weeks Before a Scheduled Inspection
"Hello, it's the FDA." A simple phone call can start your next scheduled inspection. Once you hang up the phone you better start preparing. The lead time the FDA provides is variable, but usually they allow at least two weeks of prep time. This checklist-driven presentation will teach attendees the priorities of the last 14 days leading up to the inspection, how to staff-up for the inspection and proven tips for managing data and documentation during the crunch time. Each attendee will take home a copy of a checklist that can be adapted to a specific company.
Attendees will learn:
• How to galvanize your staff to prepare for an inspection
• Priority planning to ensure the 14 days before your inspection are productive
• Document management, retention and access policies that help FDA inspectors do their jobs
Connie Hoy, Vice President, RA/QA, Cutera