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Erica Livingston

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United States

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1 to 5 of 16 total
Posted By Erica Livingston 25-Aug-2022 16:53
Found In Egroup: Regulatory Open Forum
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I have used two: IntegReview, which was purchased by Advarra. Western IRB ,which has been rebranded to WCG IRB. I haven't gotten pricing for Advarra for 2022 but in the past the IRBs we're all about the same price. ------------------------------ Erica Livingston Carlsbad CA United States ---- ...
Posted By Erica Livingston 31-Jan-2022 14:31
Found In Egroup: Regulatory Open Forum
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Hello, Does anyone have any tips for how to manage Amazon as a distributor for devices that are legally sold on their platform? I am looking for guidance on what to write in the SOP for handling a recall involving products sold through Amazon? Also, Amazon is not willing to sign any kind of distribution ...
Posted By Erica Livingston 25-Jan-2022 16:17
Found In Egroup: Regulatory Open Forum
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Hello, I am looking into the requirements of selling a product in Canada legally. The device is a menstrual cup and in the US it is class II, 510(k) exempt, not GMP exempt, OTC (no prescription required). In Canada, as far as I can tell, it is class II and there aren't any special rules, exceptions ...
Posted By Erica Livingston 25-Jan-2022 12:18
Found In Egroup: Regulatory Open Forum
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Thank you. Yes, class II, not IIa. ------------------------------ Erica Livingston Carlsbad CA United States ------------------------------
Posted By Erica Livingston 25-Jan-2022 11:07
Found In Egroup: Regulatory Open Forum
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I have seen it done a variety of ways: 1) Include relevant acronyms and definitions in each SOP  2) Have the glossary as a stand-alone document 3) Have the glossary as an Appendix in the Quality Manual 4) A hybrid of 1 and 2 or 1 and 3 where the general definitions are in the glossary and definitions ...