26/27 January 2021
GMP News |
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Medical Devices Warning Letters Report 2007
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After very high numbers of warning letters in the years 2004 (104) and 2005 (106), the total number issued in 2007 (78) can be compared to that of 2006 (79), but is still higher than in 2002 and 2003 (61 each). Within the top 5, for the first time in years the deficiencies concerning CAPA were relegated to second place by the new "front runner" design controls. The following ranks are occupied by the usual suspects. Like in 2006, process validation ranks fifth. While it ranked as high as 2nd in 2002, it slipped down to rank 8 in 2003 and rank 9 in 2004, slowly rising again to rank 7 in 2005. The following table gives an overview of the top 5 deficiencies: |
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WLs: Warning Letters The table gives only the last few digits of the CFR reference. • 21 CFR 820.20: Management responsibility |
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A broad range of validation activities is covered by the ECA course The Validation Manager to be held from 5 to 7 March 2008 in Heidelberg. |
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Author: Sven Pommeranz On behalf of the European Compliance Academy (ECA) |