expert specialist

Medical Devices Expert. MED-1824 is a sterilization expert with twenty years of pharmaceutical and medical device quality assurance management experience. His extensive background includes administration of QA/QC functions; development of QA/QC policies; analysis and resolution of QA/QC issues and nonconformances; development of corrective action programs; interpretation and implementation of GMPs and ISO 9000 standards; training and auditing for compliance to GMP and ISO; clean room design, operation, validation, and monitoring; QA microbiology; environmental control; sterilization processes and validations; EO residual testing; biological safety testing; NDA, PMA, and 510K submissions and support; PPQA reviews of new and modified products for biological safety, sterility assurance, QA microbiology, environmental control and package integrity; authoring and reviewing procedures, protocols, and validation documents; and interfacing with the Food and Drug Administr

Education

B.S., Microbiology, San Diego State University, California

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