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Michael brings over 15 years of experience providing project management, equipment, software, process validation, and quality/operational management in regulated industries. Mike’s industry experience is backed up by a strong educational background in biology, technical quality engineering, and business. Mike’s varied owner-side experience includes direct roles in quality, validation management, and compliance engineering. Mike has personally developed and applied multiple risk-based CQV programs for some of the largest biopharmaceutical companies in the world. Mike is adept at applying Quantitative Risk Management (QRM) to the design, construction, validation, operation, and maintenance of state-of-the-art global pharmaceutical and biomanufacturing facilities. Mike believes that customer service and a thorough understanding of his client's unique challenges augmented by practical knowledge and experience lead to successful projects and ultimately the development of life-saving products that improve all of their lives.