Your particular UK MDR conformity assessment basis (e.g., MDD-based, EU MDR-based, or direct UK MDR-based) needs to be known in order to answer definitively. But generally, when an economic operator like read more
Could you speak with someone at the IRB that could advise on how it should be reported? ------------------------------ Pamela Rayl Quality and Regulatory Specialist Morgantown WV United States ---- read more
------------------------------ Quality and Regulatory Specialist Morgantown WV United States ------------------------------
We've received the SBD anywhere between 3 days after receipt to 60 days after receipt. I've found that this depends on when during the year you send it. October and November, everything slows down since read more
Our experience has been much faster than 60 days. The longest time to receive it was 23 days for US companies. Faster for OUS companies. That said, we always plan for 60 days to make sure we don't end read more
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This message was posted by a user wishing to remain anonymous Dear all, Q2(R2) states that "Accuracy should be reported as the mean percent recovery of a known added amount of analyte in the sample or as the difference between the mean and the ...
This message was posted by a user wishing to remain anonymous Per China "Specification for Procedures and Technical Requirements of Drug Registration Testing (Trial Version)": The samples for registration testing should be manufactured on a commercial ...
This message was posted by a user wishing to remain anonymous Hoping for some input from this community re: initiatives that have been effective at fostering a culture of quality within your organizations. Thank you!
This message was posted by a user wishing to remain anonymous I remember reading a 21 CFR regulation stating that if a sponsor plans to use a non-compendial method when a compendial method is available, a head-to-head comparison should be included ...
This message was posted by a user wishing to remain anonymous Dear community, I'm happy to get your comments and interpretation of the applicable regulations (MDR and 2021/83/EC) for the following case: A Procedure Pack Producer (PPP) is planning ...
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