Bio
Experience
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United States
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Business Consulting and Services
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700 & Above Employee
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Dir. Regulatory Compliance
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Mar 1988 - Present
Responsible for providing guidance and understanding for our engineering, construction and validation projects in the areas of international CGMP/GLP compliance and biosafety for all types of R&D, clinical development and manufacturing facilities. Support global projects, with primary responsibility for projects executed by offices in US. Provides regulatory consulting services in areas of facility design, facility start-up and validation and facility licensing.
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Regulatory Compliance SME
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Mar 1988 - Present
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Scientist, Medical Products
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1984 - 1988
Supported the licensing of new diagnositics associated with various clinical analyzers.
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Education
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1977 - 1985University of Delaware
Suggested Services
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