Responding to FDA 483s and FDA Warning Letters - Best Practices

This webinar on responding to FDA 483s and Warning Letters will provide tips for avoiding FDA 483s and warning letters, and train you on the best practices in responding to a 483 or warning letter so that you can manage the consequences of the findings from escalating.

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.

Who Will Benefit:

• CEOs
• Regulatory Affairs professionals
• Quality
• IT
• Engineers
• Small business owners
• GxP
• Consultants