Guide to FDA Warning Letters

Certificate Short Course

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.
• 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.
Guide to FDA Warning Letters is an elective course for the Operations Management and Quality Management certificate pathways.
This course is available online, and can be taken anytime, anywhere.

 

Fee $125.00
Course Type Online
Instructor Tammy J. Culp
Duration 2 hours
Cert. Pathway(s) Operations Management
Quality Management

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$125.00