RE: RE: Official Guidlines for Risk assesment? Contribution from Mohandoss T written on 1/24/2012 at 09:07
Original contribution: RE: Official Guidlines for Risk assesment? written by JD Mallet on 1/19/2012 at 21:14) There is a draft annex given based FMEA.
Visit
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http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Q9_Briefing_Pack/Tools_-_Applications.pdf
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We can make an SOP based on this template for arriving at the score of risk.Mitigation plan will be based on the risk score.
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