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

This webinar will provide an overview of how to prepare effective responses to warning letters that FDA will consider acceptable. It will help you know how to negotiate with FDA to effectively close Warning Letters.

Why Should You Attend:

FDA is increasing the issuance of FDA-483 List of Observations following Inspections and are also increasingly turning to Warning Letters as a tool for voluntary compliance. Unfortunately, the types of issues FDA lists on the FDA-483 or is including in Warning Letters makes mere compliance not sufficient, but rather state of the art quality systems are expected by FDA. It is no longer sufficient to have a procedure and follow it. FDA may consider the procedure inadequate and evidence you follow the procedure may not be acceptable to FDA as you may have not done it up to the FDA requirements.

In this webinar we will discuss the kinds of issues FDA is citing in FDA-483’s and Warning Letters relating to quality system deficiencies. We will discuss inadequate responses and the FDA consequences for such. We will discuss how to prepare a response FDA will consider acceptable.

Finally, we will discuss how to establish quality systems that will be acceptable to FDA minimize the probability of an FDA-483, and avoid Warning Letters.

Areas Covered in the Webinar:

• Become familiar with issues that are on FDA-483’s and in FDA Warning Letters
• Know what kinds of response will not be acceptable to FDA
• Know how to effective respond to an FDA-483 or a Warning Letter
• Know what kinds of company actions can avoid Warning Letters
• Know how to negotiate with FDA to effectively close Warning Letters

Who Will Benefit:

• Quality Assurance
• Managers of Regulatory Affairs
• Directors
• VP’s
• Internal GMP Auditors
• Consultants who assist firms with Warning Letter remediation.
• All FDA regulated companies