Ben Larson

Background

About Ben Larson

ASQ-certified Software Quality Engineer with over fifteen years experience in regulated industries engaged in clinical trials, pharmaceutical manufacturing and medical device manufacturing with specific experience in the following- Management and execution of risk-qualified validation projects, including development of validation plans, requirement and design specifications, qualification protocols and summary reports- SOP planning and development for systems life cycle management; including risk assessment and management, quality assurance, change control and configuration management- Interpretation and application of statutory regulations and industry standards (GxP, QSR, GAMP5, ISO, ICH, EMEA, AAMI), especially as they relate to electronic records and signatures- Auditing of software vendors for life cycle management and quality assurance policies and procedures- Assessment of computerized systems for compliance with 21 CFR 11 and related predicate regulations and subsequent development and execution of remediation plans- Broad experience with a diversity of laboratory technologies from stand-alone analytical instruments to enterprise-wide systems. Specialties: Recognized expertise in- Validation/Verification in FDA-regulated industries - 21 CFR Part 11 assessment and remediation - Software Quality System audits - Software Project management.