Dana O'Kane's Colleagues at InQuest Science
Dana O'Kane's Contact Details
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United States
InQuest Science
Dana O'Kane's Company Details
InQuest Science troubleshoots product defect issues and provides training and guidance on particulate matter control, optimized inspection and 21CFR part 11 compliant electronic particulate and physical container/closure defect tracking systems. Focusing on Parenteral, Ophthalmic and Medical Devices to achieve a robust product lifecycle knowledge and control basis. These standardized systems are designed to assure routine particulate and defect control compliance for raw materials, API, incoming single use materials, primary components, 100% in-process inspection and AQL inspection meeting USP<1790>, USP<790>, USP<787>, USP<788> and USP<789> requirements. In Addition, we have developed logical control processes for inspector training and qualification standards management which is unsurpassed in the industry. All this, in conjunction with the appropriate forensics for defect identification and CAPA remediation leads to a high degree of sophistication in day to day process monitoring.