Regulatory Open Forum

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  • 1.  Specimen validation

    Posted 03-Feb-2016 13:32

    Hi all,

    I am looking for information in how to conduct shipping validation of blood specimens coming from outside of US to be tested in our CLIA accredited lab. This shipping would be also under the scope of a ISO 13485 certified company. Where should I start?

    Thank you in advance for any help!

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    Tatiana Ferreira PharmD
    Regulatory Affairs and Quality Assurance Manager
    United States
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