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Roy was an FDA investigator for over 21 years. He began his career with the FDA in 1976 in FDA's Atlanta District Office. He transferred to the Charlotte, NC office in 1977 as a resident investigator. During his tenure in Charlotte, he conducted inspections and investigations over a broad range of FDA-regulated commodities including Medical Devices, Pharmaceuticals, Biologics, Bio-research/ Clinical studies, Foods and Animal drugs.
He was the Resident-in-Charge of the Charlotte office from 1991 until 1993, when he assumed the position of FDA's Southeast Region Medical Device Inspectional Expert.
He was a participant of FDA's long-term training program in computer science. He conducted numerous audits of software systems for compliance with GMPs, and was a resource for FDA Investigators on software validation activities.
Roy was a member of the FDA International Inspection Cadre, and performed Medical Device Quality Systems audits world-wide.
He was a also member of FDA's Design Control Inspectional Strategy Team responsible for developing the guidance documents FDA investigators use when conducting audits of design control activities under the new Quality System regulation. Roy was very active in Design Control training for both Industry and FDA Investigators during the transition period.
Roy was an FDA Certified Performance Auditor, responsible for auditing FDA investigators under the agency's new medical device certification program.
He is a member of Institute for Electrical and Electronic Engineers (IEEE), the American Society for Quality, (ASQ) and the Association for the Advancement of Medical Instrumentation (AAMI).