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For QbD, What Should a Small Company Do and Why?

Presented at: BioProcess International Conference Raleigh, NC, October 12, 2009

QbD (Quality by Design) is seen by some as a “large company” driven initiative. It can, however, benefit small companies in both technical and business arenas (e.g., aid partnering). QbD can speed time to market, keep program focus, and help manage risks and knowledge appropriately. For QbD implementation, small companies need to keep it simple and systems should be product lifecycle appropriate.