We have covered preparing for FDA inspection (FDA Just Called! Now What?).
We have covered what to do after the FDA inspection (FDA Just Left! Now What?).
Now, in our 3rd webinar in the series, we bring information about how to work the FDA response commitments.
Linda Chatwin from UL and Walt Murray from MasterControl will share their expertise in these areas:
- How to organize internally to meet the response commitments
- Opening the CAPA(s)
- Assigning appropriate resources
- Riding herd on the resources
- Reporting back to FDA-timeline & updates
- Resolution/Verification for Effectiveness
- How serious were the findings? Am I looking at a Warning Letter or beyond what are my risks and how do I address them?
- How to engage appropriately for the serious issues
- What the FDA looks for when they return
Date: Thursday, April 14th
Time: 11:00 am EDT
Location: Your Internet Device