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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?

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.

At the completion of this session, you will be able to:

  • Identify timelines and potential regulatory outcomes of not submitting an appropriate response
  • Review the components necessary to develop a thorough response
  • Utilize a response checklist
  • Evaluate recent Regulatory observations and review associated responses
  • Recognize 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
  • Develop post-response outcomes

This course will be valuable to anyone engaged in the development, manufacturing, sale, or distribution of FDA-regulated healthcare products. Additionally, this course will provide a good primer for those involved in writing observation responses. This includes personnel in:

  • Quality
  • Manufacturing
  • Engineering

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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