A
The FDA has put out at least 3 major documents that describe how they conduct inspections (I'm sure there are more but these are the most often cited)
Guide to Inspections of Medical Device Manufacturers; 1997
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm
Guide to Inspections of Quality Systems (QSIT); 1999
http://www.fda.gov/downloads/iceci/inspections/ucm142981.pdf
Inspections of Medical Device Manufacturers, 2011
http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM244277.pdf
I've looked at the second document (QSIT) pretty closely. Would anyone who has looked at the other two be up for summarizing what they have found in the other two documents that was not necessarily covered in the QSIT guide?
Thanks -- Arianna
Guide to Inspections of Medical Device Manufacturers; 1997
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm
Guide to Inspections of Quality Systems (QSIT); 1999
http://www.fda.gov/downloads/iceci/inspections/ucm142981.pdf
Inspections of Medical Device Manufacturers, 2011
http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM244277.pdf
I've looked at the second document (QSIT) pretty closely. Would anyone who has looked at the other two be up for summarizing what they have found in the other two documents that was not necessarily covered in the QSIT guide?
Thanks -- Arianna
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