Regulatory Open Forum

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  • 1.  Temperature Loggers in Shipments

    Posted 24-Jun-2015 12:55
    Hello All,

    Does any one have experience using temperature loggers in shipments of IVDs?  Is it routine to include temperature loggers?  Any thoughts and experiences are greatly appreciated!


    Joy 

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    Joy Pelfrey
    Director of RA/QA
    Norman OK
    United States
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  • 2.  RE: Temperature Loggers in Shipments

    Posted 25-Jun-2015 10:14
    Joy,

    As for temp sensitive products, having such would be greatly helpful, sometimes even required in some countries.

    Inclusion of temp loggers can be an actionable way of avoiding "migraine" headache when you are going through customs.

    D




  • 3.  RE: Temperature Loggers in Shipments

    Posted 24-Jun-2015 13:31
    David,

    Thank you for your feedback!  Do you know if it is industry standard to regularly include them in shipments or to just used them when establishing shipping methods?

    Joy

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    Joy Pelfrey
    Director of RA/QA
    Norman OK
    United States
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  • 4.  RE: Temperature Loggers in Shipments

    Posted 24-Jun-2015 13:48
    Joy,

    I feel it should be part of industry standard practices. But it is arguable.  

    The latter would better describe current practices (e.g., use them when establishing shipping methods).

    D