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Culture Change Needed to Apply Risk Management Correctly

What may be dooming some pharma risk management projects? PharmaQbD.com spoke recently with risk management consultant Karen Ginsbury to get her views.

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You Just Need a Spreadsheet: Dispelling the Myths of FMEA

FMEA’s rightful position is as an essential link between development and manufacturing, says Dyadem’s Kevin North, who shares insight and dispels many of the myths that surround FMEA.

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A QbD Implementation Roadmap for the Generics Industry

Following a structured framework with clearly defined metrics at each stage gate will ensure a new level of quality for generics. Pharmatech's Bikash Chatterjee outlines a five-phase approach.

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