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who works at the Office of Biotechnology Products at CDER, told the WCBP forum Jan. BETHESDA, MD -- While there is talk in the industry of moving away from process validation to quality by design (QbD), even with the best that QbD has to offer, "there are simple facts of life relating to running a manufacturing process that QbD cannot ensure," an Amgen executive and former CBER official noted here July 20 at the WCBP CMC Strategy Forum. Also at WCBP 2006, Susanne Keitel, head of European Union and international affairs at Germany's Federal Institute for Drugs and Medical Devices, provided an update on European regulation. |
WCBP |
WCBA WCBB WCBBI WCBBIA WCBC WCBCF WCBCM WCBCT WCBD WCBE WCBEA WCBELS WCBF WCBG WCBH Wcbi WCBJ WCBL WCBM WCBN WCBNS WCBO WCBOE WCBOP WCBP WCBRWCBRA WCBRS WCBS WCBSN WCBT WCBU WCBV WCBVI WCBW WCBYA WCC WCC WCC WCCA WCCAA WCCAC WCCAE WCCAEW WCCB WCCBA WCCBL WCCC WCCCA WCCCC WCCCD | |||||
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