Regulatory Open Forum

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  • 1.  Exploring Regulatory Differences in Post-Market Actions (Recalls)

    Posted 31-Aug-2023 11:50
     Hello everyone,
     
    I am currently conducting research on the variations in regulations and standards pertaining to Post Market Actions, specifically focusing on recalls. I would greatly appreciate any assistance or insights you can provide regarding the distinct sections of regulations or standards that address this critical aspect of product safety.
     
    As we delve into this topic, I am interested in understanding how different regulatory bodies approach recalls, including any contrasting requirements, procedures, and guidelines they may have established. Whether it's the FDA's approach in the United States, the EMA's regulations in Europe, or any other relevant authorities worldwide, I am eager to learn about the key differences that distinguish these regulations.
     
    Moreover, if you have knowledge of specific industries such as pharmaceuticals, medical devices, automotive, electronics, or any other sector where recalls are a significant concern, your input would be invaluable. Exploring the variations across industries could provide further insight into the complex landscape of post-market actions.
     
    Please feel free to share any resources, documents, or experiences you believe might aid my research. Your contributions will be instrumental in helping me gain a comprehensive understanding of the regulatory nuances in post-market actions and recalls.
     
    Thank you in advance for your time, insights, and support. Let's work together to enhance our knowledge and contribute to improved product safety and compliance.
     
    Best regards,
     
    Zillery Fortner


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    Zillery Fortner
    Product Advisor QA/RA Life Science
    Florence KY
    United States
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  • 2.  RE: Exploring Regulatory Differences in Post-Market Actions (Recalls)

    Posted 31-Aug-2023 12:01

    Is your question specific to pharma or does include device, biologics, combination products, etc.?

    I ask because you mention EMA



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 3.  RE: Exploring Regulatory Differences in Post-Market Actions (Recalls)

    Posted 31-Aug-2023 12:19

    Hey Dan, I am looking for any life science fields (meddev, pharma, biotech, etc.).

    Thanks



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    Zillery Fortner
    Product Advisor QA/RA Life Science
    Florence KY
    United States
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