2019 - How to Write Effective 483 and Warning Letter Responses

Part 1 – Review regulatory policies and procedures in regard to FDA 483 observations or Warning Letters.
Understand the importance of responding to the observations
Discuss timelines and potential regulatory outcomes of not submitting an appropriate response
Understand who is the audience
Understand what the regulatory agency is expecting in the response
Part 2 – Structure of the Response
Review the components necessary to develop a thorough response
Review response checklist
Discuss recent Regulatory observations and review associated responses
Part 3 – Response Submission and Post Response Outcomes
Discuss the process for submitting the response to the regulatory agency
Discuss when and how to provide follow-up updates to the regulatory agency post the initial response
Discuss post response outcomes