Charles Webb is a principal consultant with Clarkston Consulting. He is a reliable, dependable, adaptable, ISACA certified QA IT Compliance Computer System Validation (CSV) subject matter expert with over 35 years of diverse experiences helping life sciences organizations comply with CSV requirements, International Standards, Directives, ISO 9001, GxP, ERES, SaMD, NDA, 510K submissions, and the FDA’s new guidance on CSA.

Charles is advanced in all areas of risk-based validation: Infrastructure Qualification, IT Governance, Quality and Compliance, Quality Assurance, SOX IT Controls, Verification Testing, 21 CFR Part 11, and cGxP Parts 210, 211, and 820. His experience spans across pharmaceutical, medical device, voice processing, biotechnology, defense, and consumer products sectors; he’s helped companies ranging from startups to Fortune 500s, including vast experience supporting multiple sites and international engagements.

Charles has successfully managed through Consent Decree with no additional fines, contributed to successful NDA submissions, and participated in several FDA inspections with no 483s, adverse findings, or observational notes. He’s also collaborated with medical directors and pharmacovigilance (PV) professionals to consolidate and restructure clinical trial sites and global implementations of validated Adverse Event systems in China, India, Twain, the Philippines, Singapore, and Australia.

Charles has a B.S. in Electrical Engineering from the University of Detroit.