|
Time |
Session Title |
Speaker(s) |
|
12:30 – 1:30pm |
Inspections at the Speed of Data: Preparing Quality Teams for FDA’s New Oversight Era |
Anne Johnson |
|
1:30 – 2:00pm |
Revised (R3) Good Clinical Practice Guideline – Looking to the Future |
Abby Statler |
|
2:00 – 2:45pm |
Quality Management Systems: Design and Application |
Abby Statler |
|
2:45 – 3:00pm |
Break
|
N/A |
|
3:00 – 4:00 |
Self-Monitoring implementation and tracking within a Comprehensive Cancer Center |
Katrina Croghan |
|
4:00 – 5:00 |
Interactive Panel: How to reinforce Quality Management fundamentals in an era of rapid innovation.
|
Panelists from Academia & Industry |
|
Time |
Session Title |
Speaker(s) |
|
12:30 – 1:30pm |
Understanding Systemic Non-Compliance |
Nancy Wintering |
|
1:30 – 2:30pm |
Audit & Inspection Readiness: From Notification to Close-Out |
Alyssa Gateman & Jessica Rowe |
|
2:30 – 3:15pm |
Root Cause Analysis & CAPA Development |
Alyssa Gateman & Jessica Rowe |
|
3:15 – 3:30 |
Break |
|
|
3:30 – 4:15 |
Leveraging QA/QC Trends for Targeted Training |
Janelle Allen |
|
4:15 – 5:00 |
Hot Topics - AI, DCTs, and More! |
TBD |
|
5:00 – 5:15 |
Conference Close-Out |
Alyssa Gateman & Abby Statler |