When
Tuesday, April 29, 2014
FDA Regulatory Compliance Primer
8:30 a.m.-10:00 a.m.
Industry & FDA Panel Discussion
10:30a.m.-12:00p.m.EDT
Lunch: 12:00 p.m.
Where
Austen BioInnovation Institute in Akron47 North Main Street
Akron, OH 44308
Driving Directions
JOIN US ON TUESDAY, APRIL 29
BRINGING YOU TWO SEPARATE, KEY EVENTS IN ONE DAY!
8:30 - 10:00 a.m.
FDA Regulatory Compliance Primer for Start Up Device Companies
LEARN from seasoned regulatory experts how to identify and set up key systems unique to your product and business
__________________________________________________________________________
10:30 - 12:00 p.m.
Industry and FDA Panel Discussion on preparation and handling FDA inspections
- Preparing for an FDA Inspection
- Conduct During an Inspection
- Responding to FDA Form 483 Observations
__________________________________________________________________________
12:00 p.m.: Lunch