Dietary Supplement GMP Inspectional Readiness VC Agenda
Dietary Supplement GMP Inspectional Readiness
A Comprehensive Road Map To 21 CFR 111
An FDAnews Virtual Conference
Thursday, June 20, 2013 • 10:00 a.m. – 3:00 p.m. EDT
Agenda
10:00 a.m. – 10:15 a.m. |
Introduction to the Virtual Conference - Dean Cirotta, President and COO |
10:15 a.m. – 11:00 a.m. |
Update on Dietary Supplement GMP Compliance Rules in the Face of FDA Scrutiny Attendees will learn:
Bob Mehta, Senior Consultant |
11:00 a.m. – 11:45 a.m. |
How to Perform Thorough Material Reviews and OOS Investigations Attendees will learn:
Bill Ment, Senior Advisor for Drug/Dietary Supplement Audit Services |
11:45 a.m. – 12:00 p.m. |
Break |
12:00 p.m. – 12:45 p.m. |
How to Properly Respond to 483s and Warning Letters Attendees will learn:
Bruce Elsner, Senior Consultant |
12:45 p.m. – 1:45 p.m. |
Lunch |
1:45 p.m. – 2:30 p.m. |
Dietary Supplement Contract Laboratories: Requirements, Selection and Qualification Attendees will learn:
Dr. Tara Couch, Consultant |
2:30 p.m. – 3:00 p.m. |
Closing Comments and Adjournment - Dean Cirotta, President and COO, EAS |