Posts Tagged ‘#Quality Audit’
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…Read More
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…Read More
Top 2018 FDA Inspection Observation Categories
Each year the FDA provides spreadsheets summarizing the areas of regulation cited in these observations at the following website: FDA.gov The spreadsheets are not a comprehensive listing of all observations but represent the a number of times it was cited as an observation on a FDA Form 483. Top categories for 2018: #1 Quality…Read More