How to Write Effective 483 and Warning Letter Responses 2019 is a webinar that covers topics such as:
- Structure of the Response
- Response checklist
- The components necessary to develop a thorough response
- Recent Regulatory observations and review associated responses
- Review regulatory policies and procedures in regard to FDA 483 observations or Warning Letters.
- Timelines an potential regulatory outcomes of not submitting an appropriate response
- Understand the importance of responding to the observations
- What the regulatory agency is expecting in the response
- Who is the audience
- Response Submission and Post Response Outcomes
- 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
- Quality Assurance
- Operations Managers
