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Vince Cebular

Sr. Compliance Consultant/Sr. VP Compliance

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""Knowledge, Skill & Passion” is not just our tagline, but something that truly motivates us to deliver world-class projects and services. I take pride in knowing that I am part of a large team of industry leading professionals that provide EPCMV services to the biopharmaceutical sector."

Vince has almost three decades of experience in cGMP consulting, engineering, facility inspections, design reviews, risk assessments, commissioning, qualification and validation within the pharmaceutical, biotech, medical gas, and medical device industries. He has a broad range of experience in the areas of bulk drug manufacturing, aseptic processing and filling, solid dosage manufacturing and packaging, medical device manufacturing, containment facilities, vivariums, utility systems, building automation systems, and laboratory support systems. Vince is experienced in the management of projects and in the preparation and execution of master plans, commissioning forms, and protocols for many types of equipment, systems, and utilities. In addition, he has experience with PLC and computer system validation in accordance with Good Automated Manufacturing Practices (Gamp) guidelines.

Vince is considered an SME in the regulatory requirements of FDA, EU, WHO, and other world-wide agencies in aseptic processing and oral solids and liquids manufacturing. Vince performs cGMP (FDA, EU, WHO, PIC/S, and RoW) consulting and design reviews for internal IPS design projects as well as for standalone compliance projects.

  • MBA - Production Management, Widener University
  • B.S. - Chemical Engineering, Grove City College
  • International Society for Pharmaceutical Engineering (ISPE)
  • ISPE Sterile Products Processing (SPP) Community of Practice, Steering Team Member and Baseline Guide Chapter Author
  • ISPE C&Q Community of Practice; Education Task, Former Team Leader and Good Practice Guide: Applied Risk Management for C&Q Task Team Chapter Co-Author
  • Cebular, Vince, et al. “Baseline Guide Vol 3: Sterile Product Manufacturing Facilities (Third Edition).” ISPE, April 2018.
  • Cebular, Vince and Jason Collins. “Flexible Parenteral Manufacturing - From Seed to Vial.” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2018 Supplement, April 2018.
  • Cebular, Vince, et al. “Trends in High Tox Manufacturing.” Pharmaceutical Processing, August 2014.
  • Cebular, Vince, et al. “Good Practice Guide: Applied Risk Management for C&Q.” ISPE, October 2011.
  • Cebular, Vince and Mark Butler. "CGMP Compliance Implications for Cell Therapy/ATMPs." ISPE Facility of the Future Conference, 7 February 2019, San Francisco, CA.
  • Cebular, Vince. "'Old School' vs. Risk-Based C&O." ISPE Canada Affiliate Annual Education and Product Symposium, 6-7 May 2019, Toronto, ON.
  • Cebular, Vince. “Annex 1 Updates.” Aseptic Processing Regulations & Technology Update Half Day Meeting, ISPE Greater Los Angeles Chapter, 11 September 2018.
  • Collins, Jason and Vince Cebular. “Breakfast Panel Session: ISPE Baseline® Guide: Sterile Product Manufacturing Facilities.” ISPE Aseptic Processing Technology Conference, 1 March 2017, Arlington, VA.
  • Cebular, Vince and Jason Collins. "’Don’t Let it Out!’ A Practical Approach to Containment in Sterile Manufacturing Facilities.” ISPE Annual Meeting & Expo, 31 October 2017, San Diego, CA.
  • Cebular, Vince, et al. “Facility Innovations for Compounding Pharmacies.” IPS Webinar, 12 December 2017, Overland Park, KS.
  • Cebular, Vince. “Preparing for an FDA Facility Audit.” ISPE LA GMP Expo & Exhibit Show, 26 May 2016, San Pedro, CA.
  • Cebular, Vince. “IQ/OQ/PQ.” Center for Professional Advancement (CfPA), Multiple Years.
  • Cebular, Vince. “Advanced Commissioning and Qualification.” Center for Professional Advancement (CfPA). Multiple years.
  • Cebular, Vince. “Best Practices for Validation of a Contract Manufacturing Facility.” Barnett International Show

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