How to Author an Effective 483 and Warning Letter Response

Duration 90 Mins
Level Intermediate
Webinar ID IQW19D0407

Part 1 – Review regulatory policies and procedures in regard to FDA 483 observations or Warning Letters

  • Understand the importance of responding to the observations 
  • Discuss timelines and potential regulatory outcomes of not submitting an appropriate response
  • Understand who is the audience
  • Understand what the regulatory agency is expecting in the response 

Part 2 – Structure of the Response

  • Review the components necessary to develop a thorough response
  • Review response checklist 
  • Discuss recent Regulatory observations and review associated responses

Part 3 – Response Submission and Post Response Outcomes

  • Discuss the process for submitting the response to the regulatory agency
  • Discuss when and how to provide follow-up updates to the regulatory agency post the initial response 
  • Discuss post response outcomes

Overview of the webinar

This course will discuss the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response. Additionally, this course will review the proper structure of the response to ensure the regulatory agency’s expectations are met and the submission process is properly understood.

Who should attend?

  • Quality Assurance Officers
  • Regulatory Affairs Officers
  • Operations Managers

Why should you attend?

The outcome of regulatory inspections is critical to an organization’s success. If the outcome of the inspection results in FDA 483 observations or a warning letter, it is important to take the observations and subsequent responses very seriously.

Faculty - Ms. Kelly Thomas

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation,  21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

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