The outcome of regulatory inspections is critical to an organization’s success. In the event the inspection results in FDA 483 observations or a warning letter, it is imperative 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 the regulatory agency’s expectations are met, and the response submission process is properly followed.
Attendees will be able to:
• Identify elements of successful responses to FDA observations, including required timelines, identification of stakeholders, and agency expectations
• Detail the structure of the Response to the FDA, including necessary components, potential reviewers, and the response checklist
• Understand the process to complete Response Submissions and to Post Response Outcomes.
This course is available online, and can be taken anytime, anywhere.