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 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.
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