Topics covered in this session:
Shawn Stevens & Susan Linn:
- Recall reporter database - general recall trends
- Speed of recalls historically. Why is it not as fast as ideal? What influences speed.
- Recall contact data affects speed of confirmed notified
- How methods of contact can reduce risk
- Template for recall communications. FDA approval.
- Recall communications audit trail
- Significant recalls that occurred while I was at FDA - and some of the issues that arose related to those recalls
- FDA ANPR going out regarding opening recalls. Can speak to how regulation may need to be changed.
- What does it mean to be recall ready?
- Effective checks - how do audit trails affect the need to do them?
- RFR - do I need to report?
Roundtable discussion > Town Hall Q&A: Open to questions from the audience