Part 1 – Review regulatory policies and procedures in regard to FDA 483 observations or Warning Letters
Part 2 – Structure of the Response
Part 3 – Response Submission and Post Response Outcomes
This 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 is properly understood.
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.
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, 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.