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Ridge Rim Associates, LLC |
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Regulatory Documents and Clinical Publications Healthcare Manufacturing and Quality Systems Solutions |
Cory J. Smith
Cory has over 20 years of experience in the diagnostics and healthcare industries. Before he began consulting, he held positions in research and development, project coordination, QA management, and manufacturing management at Genetic Systems, Inc. and Ostex International, Inc.
At Ostex, Cory was responsible for all phases of diagnostic test manufacturing. He managed the design and construction of two manufacturing plants, delivering those projects on schedule and within budget. By addressing validation and commissioning requirements during the design process, he ensured that the facilities met all requirements and could be fully validated. By keeping communications between owner and contractors focused and timely, he shortened the timelines and reduced costs.
Since Cory began consulting in 2003, he has worked for a wide variety of clients including medical device, pharmaceutical, and bio-pharmaceutical companies.
He has served on management teams of start-up companies, assisted clients in finding acceptable contract manufacturers, and helped manage those vendor relationships.
Cory has helped clients validate their new manufacturing facilities by writing validation master plans, validation protocols, and validation reports.
He has designed and implemented the required Quality Systems to meet his clients’ requirements. He has also audited potential vendors and evaluated multiple vendors to help his clients choose the most capable suppliers.