ski390 Posted January 20, 2017 Share Posted January 20, 2017 Hello everyone, Anyone willing to share their policy/procedure in regards to CAP checklist TRM.30950 - notifications to CBER? For whatever reason, I am having hard time getting this started. Thank you in advance!! Link to comment Share on other sites More sharing options...
David Saikin Posted January 21, 2017 Share Posted January 21, 2017 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. ski390 1 Link to comment Share on other sites More sharing options...
ANORRIS Posted January 23, 2017 Share Posted January 23, 2017 On 1/20/2017 at 2:45 PM, ski390 said: Hello everyone, Anyone willing to share their policy/procedure in regards to CAP checklist TRM.30950 - notifications to CBER? For whatever reason, I am having hard time getting this started. Thank you in advance!! Product_Deviation_Reporting_to_CBER-N.doc ski390 1 Link to comment Share on other sites More sharing options...
ski390 Posted January 24, 2017 Author Share Posted January 24, 2017 Thank you so much Anorris!!! You are a life saver!!! ANORRIS 1 Link to comment Share on other sites More sharing options...
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