Dan Olivier is an acknowledged expert in the field of medical and pharmaceutical system validation and safety risk management. He has supported over two hundred medical device and pharmaceutical companies in addressing regulatory issues and defining process improvement activities to enhance quality and productivity.

Dan has been contracted by the FDA to provide training for field investigators and to prepare inputs for FDA validation guidance documents. He has been a reviewer for ISO WG10 defining software process assessment standards. A frequent speaker at professional conferences and author of several seminars he has published over twenty articles on software validation, safety risk assessment, and design controls to meet FDA and ISO requirements. His company, Certified Compliance Solutions (CCS), Inc., provides validation consulting, safety risk analysis, audits, training, development, and testing services to meet the requirements of the FDA regulations, ISO 9001, and ISO 13485.

Curtis Egan is an expert in the fields of medical device and pharmaceutical systems, cleanroom quality and safety risk management. He has supported over two hundred medical device and pharmaceutical validation projects.  Curtis has been recognized for his ability to achieve difficult goals and timelines while maintaining quality and regulatory integrity of project and final documentation packages.

Curtis has over 17 years of quality system and regulatory experience in a variety of technical and management roles. This includes software validation with specialization in the development of test methods and documentation as well as leadership roles establishing standardized software validation including life-cycle processes and implementation of formal independent test engineering groups throughout those life-cycles.  Curtis is also experienced in facility and utility qualification, providing support for several Fortune 500 medical device companies, ensuring quality and performance of ISO classified cleanrooms and support utilities.

Curtis has also been a lead auditor in over 100 audits for clients including pre-assessment audits, internal audits, gap analysis audits and preparatory audits for the FDA.  Curtis has also provided direct support to clients during FDA inspections in both the US and abroad.

Larry Harvey is a senior engineer with more than 25 years technical experience, Larry Harvey has excellent skills in mechanical, electrical and software systems. He is highly experienced in validation of automated systems as well as numerous QMS procedures for compliance with FDA 21 CFR 820 and ISO 13485:2016.

Larry has assisted numerous companies in the medical device, diagnostics and diagnostic instrumentation industries. His expertise includes the development of risk management and technical design control documentation, preparation of FDA and ISO compliant quality systems procedures, compliance audits, and guidance in implementing industry best practices.

Larry is also a certified ISO 13485 lead auditor with experience as both an external and internal auditor for compliance with FDA regulations and ISO standards. He has extensive lead auditor experience in multiple internal audits and FDA readiness audits. He is also experienced in conducting supplier audits to ensure compliance with FDA 21 CFR 820, 21 CFR Part 11 and ISO 13485:2016.  His recommendations based upon practical career experience have resulted in successful outcomes for numerous FDA and third party audits.