Monday, November 19, 2012
Wednesday, March 23, 2011
FDA NEWS: TO BIG TO FAIL ?
It an open secret that one of the most respected companies in the Medical device,Pharmaceutical and consumer product manufacturing,Johnson and Johnson is in trouble with the FDA. Jand J's just got handed a consent degree by the Food and Drug Administration a week ago.Those of us who have worked at J and J know the culture of that organization:They live by their credo,and invest in people.That is why we can't understand how an organization admired by many would sink this low.Did the quest to control market share overshadow designing Quality into products? Better still,is there a correlation between growth and Quality? Many believe that in the quest to increase market share,management at J and J took their eyes off the ball,and sacrificed Quality over quantity.The problem is "Quality costs money upstream,and downstream.Either way,the organization pays.It is a pay me now,or pay me later proposition.Either way the cost of Quality has to be paid.Current good manufacturing practices require it,as a matter of fact the practice demands it.The sooner management understands that the betterSaturday, January 22, 2011
CAPA THE MYTH
CAPA is a common sense Quality improvement subsystem that has been build into this gigantic monster by folks in the medical device Pharmaceutical and Biotech industries.The acronym CAPA stands for Corrective Action and Preventive Action.Nearly everybody in these industries understands what Corrective Action is.It is the Preventive part of CAPA that they have issues with.This month we are devoting the entire blog to CAPA.The idea is to nullify the misconception and myths about in an interactive way.
David Muchemu
http://www.cgmpunversity.com
David Muchemu
http://www.cgmpunversity.com
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