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As Director of Quality Assurance at Certus International, Inc., Mr. Ehrhardt designs and implements quality assurance infrastructure that balances regulatory compliance and supports good clinical practices. He collaborates with staff to develop specific QA-related activities within clinical monitoring, data management and report writing functions. In addition, he provides review and oversight of projects that are likely to have extensive multiple discipline linkages. Mr. Ehrhardt assesses PET operations, radiochemistry and dose compounding activities for conformance to sponsor clinical trial requirements, monograph requirements, regulations, guidelines and standards. He also develops PET dose compounding records and quality system infrastructure to incorporate PET center chemistry and formulation activities and evaluates by audit the integrity of PET precursor chemistry, synthesis, and quality control operations and facilities. Mr.Ehrhardt creates quality system guidelines, policies and procedures to implement quality assurance in global organizations engaged in the design, manufacture, and distribution of medicinal products, medical devices and specialty chemicals and conducts a variety of assessments against guidelines, standards and regulations in support of quality system compliance management. Prior to joining Certus, Mr. Ehrhardt was the Vice President, Quality, at Mallinckrodt, Inc. (St. Louis, MO area), where he developed, organized and directed a worldwide and culturally diverse organization of about 800 persons engaged in quality assurance using a dispersed organizational model competitive in cost and size with world-class benchmarks. Mr.Ehrhardt influenced quality-related decisions of management and employees to achieve essentially error free design, manufacture, distribution and servicing of products having critical impact on patient health and well-being and delivered a quality system certification strategy to cGMPs, the QSR, and ISO that effectively balanced customer, regulatory and shareholder interests. Mr. Ehrhardt also integrated diverse and technologically complex acquisition companies into a uniform corporate quality system structure and led negotiations with international regulatory agencies that resulted in substantial compliance ratings for inspections and approved product registration submissions. | 