How to Write Effective 483 and Warning Letter Responses

Live Webinar

  • 90 minutes

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 serious. 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.

Join this session by expert speaker Kelly Thomas, where she will review the proper structure of the response to ensure the regulatory agency’s expectations are met and the submission process is properly understood.

Session Highlights:

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

Why You Should Attend:

Every GMP manufacturing facility will experience a regulatory inspection at some point. If the outcome of the inspection results in a 483 or a Warning Letter, the firm must respond to the agency in a timely and proper fashion in order to avoid additional regulatory action. Attendees of this course will understand regulatory expectations for firms that have received a 483 or Warning Letters; as well as, the consequences of not providing a proper response. Attendees will learn how to correctly structure and submit the response to ensure the regulatory agency’s expectations are met and the submission process is properly executed.

Who Should Attend:

  • Quality Assurance

  • Regulatory Affairs

  • Operations Managers

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Kelly Thomas

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, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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