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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 ICH [the quality risk management guidance of the International Conference on Harmonization] has a good toolbox," she adds. Q9 toolbox
More stories about FDA International Conference On Harmonization Risk Assessment Quality Risk Management
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