Effective (and FDA Accepted Responses) to FDA 483s and Warning Letters

If you work for any firm that manufactures products regulated by FDA, you very likely will experience an FDA inspection.

You should have a well developed quality system in place, but FDA eyes sometimes expect something slightly different, or they may see actions or practices they believe are contrary to FDA requirements and then issue an FD-483

Virtually every regulated company will receive an FDA-483 at some point in time and need to create a written response to FDA, although FDA has no legal authority to demand a written response

Repeat Observations from a previous FD 483 are a red flag to FDA

Failure to adequately respond to the FDA-483 will begin the FDA regulatory process.

An FDA Warning Letter is your last chance to avoid an FDA regulatory confrontation. You must provide a detailed complete Warning Letter response and have a meeting with FDA.

Why should you Attend: Effective and FDA accepted response are critical to regulatory success of FDA regulated business

My experience with FDA and Industry have shown me that some firms make a very limited response to FDA, and when FDA reviews the response they feel to company did not fully comprehend, the problems.

This webinar will prepare you fully evaluate the FDA observation, and prepare a detailed response to FDA and convince FDA no further action is needed by them

Areas Covered in the Session:

• What is an FDA-483, what it is not
• What is a Warning Letter, what it is not
• Greatest mistakes in responding to FDA
• Examples of poor and incomplete responses
• How do you know if FDA is pleased with your response

• VP's of Regulatory Affairs
• Regulatory Managers
• Consultants who assist clients with FDA Matters