Speaker Abstract: S-22
The Science of Quality by Design
Janet Woodcock, M.D., Acting Deputy Commissioner for Operations/FDA
One of the objectives of FDA's "Pharmaceutical Quality for the 21st Century" Initiative is to strengthen the scientific basis of both pharmaceutical manufacturing and FDA regulation of manufacturing. The initiative steering committee and working groups have done an extensive assessment of the current scientific and technological framework. There are many opportunities for improvement. An emerging definition of pharmaceutical quality will be presented. Critical links between "designing quality in" during pharmaceutical development, and maintenance of quality within cGMPs, will be explored.
2004 FDA Science Forum | FDA Chapter, Sigma Xi | CFSAN | FDA
Last updated on 2004-MAY-28 by frf