About

Consultants specialize in Quality Systems (FDA CGMP /QSR, ISO 13485) management and compliance assessments, Design Controls for New Products, Design Validations (including Human Factors and usability), Process Validations, Risk Management (ISO 14971), and Supplier Quality. Expert in Change Control processes, NCR/MRB processes, CAPA, Complaint Handling, Root cause Investigations, Management review metrics, Audits, and preparation of responses to FDA audit observations, as well as remediation planning and execution. Consultants are highly skilled in the application of statistical techniques and Six Sigma Black Belt certified.