Inspections — From the Routine to the Truly Bizarre - Webinar CD/Transcript
Inspections — From the Routine to the Truly Bizarre: How to Deal with Challenging Situations
As you are well aware, even a routine FDA inspection can be problematic — challenging — or truly bizarre.
What if the inspector calls one of your line operators untrained and is hiding something?
What if the investigative team arrives without one of its key members, but wants to begin the inspection immediately?
How do you respond to these situations?
Join storyteller and expert regulatory compliance specialist Steve Niedelman of King & Spalding as he discusses these and other real-life situations. Steve has participated in hundreds of FDA inspections involving both small and large manufacturers.
After attending this 90-minute session you will be able to:
- Deal with the most challenging FDA inspectors and situations, including unannounced inspections during trying times
- React positively to unanticipated actions by FDA inspectors, such as the stalking of one of your female employees
- Realize the FDA inspections are all about being prepared for all eventualities — while remaining flexible to existential events such as your inspector suddenly taking pictures with his smartphone
Order today and be prepared to deal with the challenging inspection situations that an FDA inspector may throw your way.