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Mike earned his Bachelors Degree (B.S.) in Biology from Pennsylvania State University and has been working in the pharmaceutical field for approximately 11 years. Mike has worked in many facets of the industry, starting in the lab working with industry leading equipment to perform bench chemistry and microbial identification. He moved from the lab into a manufacturing environment where he worked on the scale-up, manufacturing, and testing of different compounds, vaccines, and intermediates. Mike began working in systems compliance approximately 9 years ago, specializing in laboratory computer system operation, automation, validation, and regulatory compliance. Through his experience, Mike began working on projects as a lead and then as a Project Manager, handling multiple accounts. He is now responsible for the department, which includes projects in the areas of laboratory systems, laboratory based IT systems, data acquisition systems and information management systems. He is also responsible for providing internal and external industry training on many topics including Validation System Life Cycle, 21 CFR Part 11 applicability and adherence, and laboratory systems control. Mike has achieved certification by the American Society of Quality as a Quality Auditor, and has performed many vendor audits in both the US and Europe. | 