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

Larry Stevens Instructor:
Larry Stevens 
Tuesday, December 5, 2023
10:00 AM PST | 01:00 PM EST
60 Minutes
Webinar ID: 501664

More Trainings by this Expert

Price Details
Live Webinar
$149 One Attendee
$299 Corporate Live
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded
Combo Offers
Live + Recorded
$299 $348 Live + Recorded
Corporate (Live + Recorded)
$599 $698 Corporate
(Live + Recorded)

Live: One Dial-in One Attendee

Corporate Live: Any number of participants

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)


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

Who Will Benefit:
  • VP's of Regulatory Affairs
  • Regulatory Managers
  • Consultants who assist clients with FDA Matters

Speaker Profile
Lawerence Stevenshas a unique background of FDA and Industry experience. He has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has eighteen 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 which reviewed over 30 PMA clinical studies for cardiovascular devices. He currently serves as an expert witness for cases involving FDA regulation compliance for medical devices. He regularly performs webinars regarding FDA and issues regarding clinical studies and medical devices. Finally, he is a seasoned educator/speaker with over 150 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public.

You Recently Viewed

Subscribe to our Newsletter

Subscribe for Compliance Alerts Research Reports Absolutely Free