How to Write Effective 483 and Warning Letter Responses 2019
12 Mar 2019
Webinar
Description
Topics
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
Who should Attend
Regulatory Affairs Departments
Quality Assurance Departments
Operations Departments
Engineering Departments
Past Events
How to Write Effective 483 and Warning Letter Responses 2019 - 12 Mar 2019, Webinar (82575)
Important
Please, check "How to Write Effective 483 and Warning Letter Responses" official website for possible changes, before making any traveling arrangements
