How to Write Effective 483 and Warning Letter Responses 2019 is a webinar that covers topics such as:
- The importance of responding to the observations
- Regulatory policies and procedures in regard to FDA 483 observations or Warning Letters
- Who is the audience
- Timelines and potential regulatory outcomes of not submitting an appropriate response
- Of the Response
- What the regulatory agency is expecting in the response
- Response checklist
- The components necessary to develop a thorough response
- Response Submission and Post Response Outcomes
- Recent Regulatory observations and review associated responses
- When and how to provide follow -up updates to the regulatory agency post the initial response
- The process for submitting the response to the regulatory agency
- Post response outcomes
How to Write Effective 483 and Warning Letter Responses 2019 is intended for:
- Regulatory Affairs Departments
- Quality Assurance Departments
- Operations Departments
- Engineering Departments
