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How to Write Effective 483 and Warning Letter Responses - Webinar

  • ID: 4899827
  • Webinar
  • March 2019
  • Region: Global
  • 90 Minutes
  • Compliance Online
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Why Should You Attend:

Every GMP manufacturing facility will experience a regulatory inspection at some point. If the outcome of the inspection results in a 483 or a Warning Letter, the firm must respond to the agency in a timely and proper fashion in order to avoid additional regulatory action.

Attendees of this course will understand regulatory expectations for firms that have received a 483 or Warning Letters; as well as, the consequences of not providing a proper response. Attendees will learn how to correctly structure and submit the response to ensure the regulatory agency’s expectations are met and the submission process is properly executed.

Areas Covered in the Webinar:

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
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Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
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