| April 7 |
| 7:30
- 8:00 |
Registration and
Continental Breakfast |
| 8:00
am - 8:15 am
|
Welcome
Dr. Scott Sutton
|
| 8:15
am - 9:00 am |
The CFR and a History of GMPs
Scott Sutton |
| 9:00
am - 10:00 am
|
Quality Systems in the Microbiology Lab Lucia
Clontz |
| 10:00
am - 10:30 am |
Break |
| 10:30
am - 11:30 am |
Lab Design Karen
McCullough |
| 11:30
am - 12:30 pm |
Microbial Diversity in Pharmaceutical Product
Recalls Luis Jimenez |
| 12:30
pm - 1:30 pm |
Lunch |
| 1:30
pm - 3:00 pm
|
FDA Panel Discussion - Video-conference with FDA
CDER/ORA Inspectors |
| 3:00
pm - 3:30 pm |
Break |
| 3:30
pm - 4:30 pm
|
USP <1117> and the FDA Guide to Inspections of
Pharmaceutical QC Microbiology Labs Scott Sutton |
| 4:30 pm - 5:00 pm |
Panel Discussion/Review with Speakers |
| 6:00
pm - 8:00 pm |
Reception
(Casual Dress) |
