Name
How to Ensure Your Drug or Biologics Manufacturing Facility Is Ready to be Evaluated by the FDA Either Remotely or In-Person
Date & Time
Thursday, November 17, 2022, 11:00 AM - 12:15 PM
Description

Whether the FDA will evaluate your facility using remote tools or an on-site inspection, it is important to be ready. This session will discuss what is new about the FDA’s use of remote tools and how you can prepare for both remote record requests and remote interactive evaluations. In addition, drugmakers may have fallen behind on traditional inspection readiness activities due to the pandemic. This session will focus on risk areas to be aware of as you conduct inspection readiness activities.

William Mestrandrea Ron Branning Bob Darius David Chesney
Track
Drugs & Biologics
Location Name
Salon 1-3