Where
Montage Banquet Center, Indianapolis8580 Allison Pointe Boulevard
Indianapolis, IN 46250
Driving Directions
"A Deep Dive Into Inspection Preparedness"
Join IMDMC as we explore all the perspectives of the FDA inspection process. Hear from a panel of experts who will give you tips on everything you need to know from the day you receive the call to how to respond, how to set up for the inspection and how conduct the opening and closing meetings. Learn what you should do immediately after the inspection and how to respond to 483's and warnings. This is a very in-depth workshop you won't want to miss! CLE credits will be offered
8:30 AM - 4:00 PM Lunch will be provided
INTENSE WORKSHOP INCLUDES THE FOLLOWING AGENDA ITEMS
- FDA LAWS AND REGULATIONS
- FDA AUTHORITY
- LEGAL SCOPE OF INSPECTIONS
- TYPES
- ENFORCEMENT ACTIONS
- QUALITY SYSTEM INSPECTION TECHNIQUE
- PRIORITIES & FOCUSES
- FDA INSPECTION VS ISO AUDIT
- NEWEST SOFTWARE FOR DOCUMENTS AND RECORDS
- SETTING UP A WAR ROOM
- HOW TO CONDUCT MEETINGS
- WHOM TO INVOLVE
- 483'S AND WARNINGS - HOW TO RESPOND
- PANEL DISCUSSION