How to Write Effective 483 and Warning Letter Responses

In this regulatory inspection webinar attendees will learn 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. Also attendees will learn the proper structure of the response to ensure the regulatory agency’s expectations are met and the submission process is properly understood.

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.

Areas Covered in the Session :

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

Structure of the Response

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

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

Who Should Attend:

• Quality Assurance Departments
• Regulatory Affairs Departments
• Engineering Departments
• Operations Departments

Course Director: 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.