Faculty: Kelly Thomas
In this regulatory inspection webinar attendees will learn 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. Also attendees will learn the proper structure of the response to ensure the regulatory agency’s expectations are met and the submission process is properly understood.
Why You Should Attend:
Every GMP manufacturing facility will experience a regulatory inspection at some point. If the outcome of the inspection results in a 483 or a Warning Letter, the firm must respond to the agency in a timely and proper fashion in order to avoid additional regulatory action.
Attendees of this course will understand regulatory expectations for firms that have received a 483 or Warning Letters; as well as, the consequences of not providing a proper response. Attendees will learn how to correctly structure and submit the response to ensure the regulatory agency’s expectations are met and the submission process is properly executed.
Areas Covered in the Session :
Review regulatory policies and procedures in regard to FDA 483 observations or Warning Letters
Structure of the Response
Response Submission and Post Response Outcomes
Who Should Attend: