Supplier Risk Assessment Essentials

Supplier Risk Assessments The FDA and ICH Q10 have provided direction on the need to risk assess suppliers as a part of the Quality System.  Way back in 2011 the following slide was presented at the Pharmaceutical Quality System ICH Q10 Conference. The Supplier Identification Model or better known as the Supplier Quality Management Lifecycle…

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Pain is Weakness Leaving the Body!

Pain is Weakness Leaving the Body! I love this old military mantra!  Or then there’s “No pain no gain!” Sometimes a little bit of pain goes a long way for ultimate success! We accept this mantra at Quality Audit Consulting (QAC)! We can help you get through your growing pains with a gap assessment for…

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