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ski390

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  1. Like
    ski390 got a reaction from ANORRIS in TRM. 30950 CBER notification policy   
    Thank you so much Anorris!!! You are a life saver!!!
  2. Like
    ski390 reacted to David Saikin in TRM. 30950 CBER notification policy   
    I only notified for biologic product deviations.  You also have to notify in case of a transfusion associated fatality.  You should already have those policies written.  No need to have a separate one that includes both as long as they are already there.  That standard doesn't need to be achieved with a single policy.  As long as you meet it.
  3. Like
    ski390 reacted to ANORRIS in TRM. 30950 CBER notification policy   
    Product_Deviation_Reporting_to_CBER-N.doc

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