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Mark E. Rezac, PE

Director, Compliance Services

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"There are a lot of opportunities to streamline traditional commissioning and qualification by focusing time and effort on what is important for product quality."

Mark offers clients more than 30 years of senior-level management experience in assuring Current Good Manufacturing Practice (CGMP) compliance, as well as commissioning and qualification of state-of-the-art global pharmaceutical and biomanufacturing facilities. Sigma Black Belt certified, Mark is considered a subject matter expert on vaccine, biotechnology, pharmaceutical and research facilities around the world. Mark has established and implemented quality and compliance programs, led cross-functional teams and improved business and manufacturing operations through capital improvements. Mark has successfully directed design, engineering, construction, start-up, qualification and turnover of both large and small projects, through regulatory licensing and approval for operation and now focuses on assisting clients in meeting their CGMP challenges by identifying and applying practical, compliant engineering solutions.

  • MBA - Katz Graduate School of Business, University of Pittsburgh
  • B.S. - Civil Engineering Technology, University of Pittsburgh
  • International Society for Pharmaceutical Engineering (ISPE)
  • ISPE C&Q Community of Practice, Steering Team Member
  • Merck & Co.
  • Rezac, Mark, et al. "Baseline Guide Vol 5: Commissioning & Qualification, 2nd Edition.” ISPE, June 2019.
  • Rezac, Mark. “Commissioning and Qualification Baseline Guide Volume 5 - Polishing on Old Gem.” ISPE Annual Meeting & Expo, 6 November 2018, Philadelphia, PA.
  • Rezac, Mark. “FDA Inspection Preparations: What’s New, What’s Different.” INTERPHEX, April 2018, New York City, NY.
  • Rezac, Mark. “Aseptic Facility Design.” JGC GMP Seminar, 30 November 2017, Japan.
  • Rezac, Mark. “Contamination Control with Isolators and RABS in Aseptic Fill Finish Facilities.” FDA Training Session, 18 July 2017, Silver Spring, MD.
  • Rezac, Mark. “Practical Application of Risk-Based C&Q.” ISPE Annual Meeting & Expo, 30 September 2016, Atlanta, GA.
  • Rezac, Mark. “Aseptic Fill/Finish Contamination Control Strategies.” FDA Lecture and Plant Tour, 2016.
  • Rezac, Mark. “Risk-Based Qualification - 10 Years After the Landmark ISPE White Paper on Risk-Based Qualification for the 21st Century.” ISPE Annual Meeting & Expo, November 2015, Philadelphia, PA.
  • Rezac, Mark. “RABS & Barrier Isolation Technology.” FDA Lecture Course DG 330, 2014 and 2015.
  • Rezac, Mark. “Building Compliance Into Facility Design and Construction.” PDA Metro Chapter Day Symposium, 2014.
  • Rezac, Mark. “C&Q: Fulfilling Stage 2A of the FDA Process Validation Guideline - Part I (Implementing Stage 2A, Fitness-for-Use to support PV. Linking product/process requirements to product quality).” ISPE Annual Meeting & Expo, 31 October 2014, Las Vegas, NV.
  • Rezac, Mark. “Pharma Manufacturer’s C&Q Risk Approach Task Team Forum.” ISPE Annual Meeting & Expos, 2009 - 2012.
  • Rezac, Mark. “Panel Discussion - Practical Risk-based Commissioning and Qualification.” ISPE, 2012.

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