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Risk Assessment

Latest Headlines

Latest Headlines

Catalent fined in worker dermatitis cases

Catalent Pharma has been fined $76,000 by U.K. safety officials after at least 10 manufacturing workers came down with allergic contact dermatitis. The contract services provider, located in Swindon,

Turn to ICH for risk tools

There are many ways to do risk assessment, says Elaine Morefield of the FDA during this week's ISPE conference. Failure mode and effects analysis (FMEA) and fishbone diagrams are among them. "Q9 of