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

Larry Stevens
RAC Principal Consultant, One Way Consultants, LLC, FDA Regulatory Expert

J. Lawrence Stevens, RAC, who has over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel. Finally, a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. As a consultant he has presented over 20 webinars on FDA requirements.

Mr. Stevens has met numerous times with FDA as a member of industry, and with industry numerous times as an FDA Official. He is keenly aware of what pitfalls must be avoided, and what FDA expects from the firm with whom they are meeting. Now as a consultant, Mr. Stevens assists firms in meeting FDA requirements and conducting successful FDA meetings.

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