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Guide to FDA Warning Letters
May 20, 2020 @ 9:00 am - 11:00 am
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. This course discusses the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters, as well as providing essential elements of a thorough response. Additionally, this course reviews the proper structure of the response to ensure that the regulatory agency’s expectations are met and the submission process is properly understood.