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Mary, Thanks so much for your interest. We will be teaching the class again. When we offer it, I will post it again on Regulatory Exchange. With warm regards, Nancy ------------------------------ Nancy Singer JD, FRAPS, RAC President, Compliance-Alliance Compliance-Alliance Arlington VA United States ------------------------------

Also of interest Uwe is that the Notified Bodies have a long precedent of accepting that harmonized standards can be applied either in full, or in part, depending on the manufacturer's particular objective regarding a corresponding requirement(s). ------------------------------ Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada) Principal Consultant ...

Dear colleagues, I'm currently looking into the status of international countries and eCTD. I know over the last years already a number of countries made eCTD the mandatory dossier format. But I would live to see an overview of who already implemented it, who is on the way and how about eCTD 4.0. Any suggestions where to find this information is welocme. ...

Nicholas and others, Along with the books and other RAC Devices preparation materials, here are additional tools that I found useful in preparing for the exam: Chunking the text book with sticky note tabs.  Thank you to the person who suggested this sticky-note method for getting through a text book.  It worked.  I gave myself 20 days to read the ...

Agnes Szoboszlai and I wrote an article about how to do this in RAPS Focus: https://www.raps.org/news-and-articles/news-articles/2019/10/implementation-of-shared-mdr-economic-operator-res The article discusses how to do this in a corporate group, but the thinking can also be implemented between independent economic operators. ------------------------------ ...