This is a typical pharma development & operations, and apart from other things, people are unable to distinguish failure modes to be considered at various stages of FMEA.
I have come up with following broad-outline to help focus performing assessment.
This is actually backed up by detailed SOP, but here I want to hear from Risk-Gurus on approach.
I have come up with following broad-outline to help focus performing assessment.
This is actually backed up by detailed SOP, but here I want to hear from Risk-Gurus on approach.
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