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Mark Rezac, PE, MBA

Director, Compliance Consulting

Regulatory Compliance Expert

Areas of Expertise

  • FDA / EMA and Global Regulatory Compliance
  • Lean Six Sigma, Black Belt
  • Engineering Quality Management Systems
  • cGMP Facility Design and Design Review
  • Manufacturing Facility cGMP Assessments
  • Product Quality Risk Assessments
  • Commissioning, Qualification and Validation (CQV)
  • Application of Quality by Design (QbD) to streamline CQV
  • ASTM E2500 Execution
  • Technical Consultancy 
  • Validation Master Planning


The current industry and regulatory focus on risk management is creating exciting opportunities to "build in" quality through the manufacturing design, construction, and qualification process. It's rewarding to help develop innovative engineering solutions to achieve excellent product quality which will ultimately benefit the patients.

- Mark Rezac
Director, Compliance Consulting

Mark is an industry subject matter expert in FDA, EMA and global regulations governing design, construction, commissioning and qualification of cGMP facilities and equipment. 

Mark has developed broad experience across the project delivery process in a wide variety of manufacturing technologies executed globally.  His familiarity with global regulatory expectations and unique understanding of the nuances of CQV provides valuable guidance to design and construction teams striving to achieve lean and efficient regulatory compliance. 

Mark contributes to the industry body of knowledge as the co-leader of ISPE’s C&Q Community of Practice Steering Team.  He has been a frequent presenter at association meetings, conferences and industry events on such topics as "Building Compliance into Facility Design and Construction" (PDA) and “Pharma Manufacturer’s C&Q Risk Approach Task Team Forum" (ISPE).  Mark has achieved Black Belt certification in Lean Six Sigma. 

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  • p. 888.366.7660

Recent Projects

  • OSD Facility Due Diligence Assessment
  • OSD Atypical Visual Particle Risk Assessment
  • Product Contamination Design Risk Assessment
  • GMP Production Facilities Design Reviews
  • Barrier Technology Training