How to Respond to FDA 483's & Warning Letters - Webinar

  • ID: 3734858
  • Webinar
  • 60 Minutes
  • Pathwise
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During the close out meeting, the FDA investigator issues your company a Form FDA 483.-Could a well-written response prevent the Agency from issuing a warning letter, too? In 2013, the Food and Drug Administration (FDA) issued over 600 warning letters based on the expectation that companies will voluntarily comply with the law.-

The purpose of your response is to convince the Agency that the issues identified during the inspection were understood, corrected and prevented.-To be adequate, your response must be concise, correct and timely.

This webinar can help you prepare better responses by:

- Reviewing the process for issuing 483s and warning letters
- Assessing how and when to respond to 483s and warning letters
- Examining current trends in 483 observations and recent letters
- Proposing response strategies

After attending this webinar, participants will be able to:

- Recognize timely and adequate responses
- Identify timeframes for submitting written responses
- Recognize the most frequent observations and citations
- Identify an effective corrective action plan
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Kitty Williams
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