Avoiding FDA 483
About This Event
This 2-hr webinar will assist you in responding to a 483 or Warning Letter so that the consequences of the findings do not escalate beyond the current status.
Why Should You Attend:
Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. Each year, the FDA conducts several thousand audits, approximately half of which lead to findings that result in Form 483s. Most Form 483 audits are amicably resolved, but a few lead to serious consequences for the audited parties, starting with Warning Letters and ending with heavy fines and jail time for a few.
This webinar, will assist you in responding to a 483 or Warning Letter so the consequences of the findings do not escalate beyond the current status.
Areas Covered in the Seminar:
- FDA Inspections - background.
- Causes of Form 483 / Warning Letter.
-Some recent results of companies failing to respond appropriately.
- Best Practices for Responding to 483.
- Best Practices for Responding to Warning Letter.
- What to do if the responses fail.
Event Details:
Date: October 12, 2012
Time: 10:00 AM-12:00 PM PDT
Cost: $249 per attendee per computer terminal
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