Quality and Compliance Consulting

Assess existing QMS, FDA and Notified Body remediations, as well as preparation and education of site personnel in anticipation of regulatory compliance external inspections to ensure successful results with minimal observations. 

Creation of right-sized, scalable, PRACTICAL and COMPLIANT quality documentation for efficient and sustainable operations and quality processes RESULTING in high quality products, successful quality audits and external inspections.

Working with site leaders, I will perform a thorough, deep-dive, value-added analysis of your quality processes to identify gaps in regulatory compliance and will establish comprehensive plans to ensure lasting corrective actions.