How to Write Effective 483 and Warning Letter Responses

This 90-minute 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.

Why should you Attend
The outcome of regulatory inspections is critical to an organization's success. The FDA performs inspections to check that companies are maintaining compliance with applicable regulations and quality standards. Though you do your best to avoid it, receiving a 483 or Warning Letter is inevitable.

It's important to take the observations very seriously, because you only have 15 days to submit the subsequent responses. But ensuring that you are aware and understand what the regulatory agency is expecting in the response can be a challenge. What should you include? What are the risks of not submitting an appropriate response?

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 Will Benefit
Speaker Profile
Kelly 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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