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Michael Westerman

Sr. Director, CQV Operations

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"It takes a village."

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 with 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 clients’ unique challenges augmented by practical knowledge and experience lead to successful projects and ultimately the development of life-saving products that improve all of our lives.

  • MBA - Pharmaceutical Management, Drexel University
  • B.S. - Biology, Pennsylvania State University
  • International Society for Pharmaceutical Engineering (ISPE)
  • Parenteral Drug Association (PDA)
  • PCI Services
  • Sanofi-Aventis
  • Sanofi-Pasteur
  • Westerman, Michael. "Risk Based Approach to Validation." ISPE Midwest Chapter Annual Tech Ed Day, 15 May 2019, Kansas City, MO.
  • Westerman, Michael and Franklin, Daniel. “Risk-based C&Q (T55).” ISPE Classroom Training, 23-24 July 2019, St. Louis, MS.
  • Westerman, Michael. “Course # T-48: Risk-Based Verification of Facilities, Systems and Equipment." ISPE Annual Meeting, 8 November 2018, Philadelphia, PA.
  • Westerman, Michael. “Course # T-48: Risk-Based Verification of Facilities, Systems and Equipment Workshop.” Quality Assurance for Facilities Management Training Course, 10-11 November 2016, Tampa, FL.
  • Westerman, Michael. “Overview of FDA Process Validation Observational Trends.” ISPE Process Validation Conference, 24-26 October 2016, Bethesda, MD.
  • Westerman, Michael. “Process Validation Regulatory Observation Trends.” ISPE Process Validation Conference, October 2016, Bethesda, MD.
  • Westerman, Michael. “Implementation of Lifecycle Validation Practices at CMOs.” ISPE/PQRI Process Validation Conference, 8 October 2015, Silver Spring, MD.
  • Westerman, Michael. “Annex 15 - Draft Changes Summary: A Review of the Most Significant ISPE Comments Submitted Through ISPE.” ISPE Annual Meeting & Expo, 15 October 2014, Las Vegas, NV.
  • Westerman, Michael. “Tools for Achieving and Maintaining Operational Excellence (Facing Your Challenges without a Black Belt: Solve Problems and Achieve Consensus with Simple, Well Applied Tool).” ISPE Annual Meeting & Expo, 15 October 2014, Las Vegas, NV.

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