Jump to content

TRM. 30950 CBER notification policy

ski390
in Transfusion Services

Featured Replies

Posted
comment_68458

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!!

  • Replies 3
  • Views 1.7k
  • Created
  • Last Reply

Top Posters In This Topic

Popular Days

Most Popular Posts

  • David Saikin
    David Saikin

    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

  • ANORRIS
    ANORRIS

    Product_Deviation_Reporting_to_CBER-N.doc

  • ski390
    ski390

    Thank you so much Anorris!!! You are a life saver!!!

comment_68468

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.

    comment_68487
    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

    • Create an account or sign in to comment

    Go to topic listing

    Recently Browsing 0

    • No registered users viewing this page.

    Important Information

    We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.

    Configure browser push notifications
    Chrome (Android)
    1. Tap the lock icon next to the address bar.
    2. Tap Permissions → Notifications.
    3. Adjust your preference.
    Chrome (Desktop)
    1. Click the padlock icon in the address bar.
    2. Select Site settings.
    3. Find Notifications and adjust your preference.