How to Write Effective 483 and Warning Letter Responses 2019

Topics

• 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

Who should Attend

• Regulatory Affairs
• Quality Assurance
• Operations Managers