By Bikash Chatterjee, President and CTO, Pharmatech Associates
Tag Archive | "FMEA"
A QbD Implementation Roadmap for the Generics Industry
Posted on 16 July 2010.
Posted in Expert Insights, ResourcesComments (0)
You Just Need a Spreadsheet: Dispelling the Myths of FMEA
Posted on 27 April 2010.
Toronto’s Dyadem provides Quality Risk Management (QRM) solutions and helps biotech and pharma companies establish a foundation for an ICH Q10 Pharmaceutical Quality System. We recently spoke with CEO Kevin North about a critical aspect of risk management, FMEA.
PQbD: What is FMEA’s role in a Quality by Design context? What function does it perform?
Posted in Expert InsightsComments (0)
Culture Change Needed to Apply Risk Management Correctly
Posted on 30 March 2010.
Imagine a crossfunctional team made up of 90% QA, or operators who say “we can’t solve that problem so why even write it down,” and you’ll get an idea of what may be dooming some pharma risk management projects. PharmaQbD.com spoke recently with risk management consultant Karen Ginsbury to get her views.
Posted in Expert InsightsComments (0)
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