Timelines are tight, budgets are stretched, final adjustments happening near the last moments of project completion to ensure success, sound familiar? The industry faces these pressures constantly and this pressure only intensifies during CQV being one of the last critical elements before manufacturing can begin. Through real like experiences, this panel will discuss ways in which CQV teams can key in on agile implementation philosophies, approaches, and technical implementation solutions such as electronic validation tools that drive synergies and efficiencies all the while delivering a comprehensive CQV package.
Speakers: Laura Berberian, Senior Manager, QA Validation, ElevateBio Andrew Doran, CQV Engineer II, Arcadis DPS Group Patrick Mullin, Commissioning & Qualification Lead, Specialty Care GBU, Sanofi Forrest Brown, Director, Facilities and Engineering at ReciBioPharm
Laura Berberian is the Senior Manager, QA Validation at ElevateBio with 8+ years’ experience in the biopharma industry. In her current role, she supports CQV projects, Kneat, and capital projects for cell and gene therapy manufacturing at Elevate’s BaseCamp facility in Waltham, MA. Laura began working with Elevate in 2019 and was instrumental to developing their CQV program and the build-out of the Waltham BaseCamp facility. Prior to Elevate, Laura held various positions in validation consulting, engineering, and project management. She is also actively involved in ISPE, currently serving as the Chair of the Boston Area Product Show Committee for the 2023-2024 show and is a member of ISPE’s Paperless Validation sub-committee. Laura holds a BS in Chemical Engineering from Northeastern University.
Andrew Doran is a Commissioning Qualification and Validation Engineer II at Arcadis DPS Group. Andrew graduated cum laude from Rochester Institute of Technology with a Bachelor’s in biomedical engineering and has 3+ years of experience in the Biotech/Biopharma industry. His recent consulting experiences have mainly consisted of the application of Quality System policies, and project management, as well as the qualification of equipment, clean utilities, controlled temperature units, and controlled room environments.
Patrick Mullin oversees the management of C&Q activities for capital projects across multiple sites in US and Europe. He possesses over 20 years of experience in the CQV space specializing in CQV project management/project controls, digital CQV deployment, and CQV compliance.
Forrest Brown is the Director of Facilities & Engineering at ReciBioPharm, the biologics business unit within leading CDMO Recipharm. He is responsible for facilities, engineering (process and automation), metrology and validation at the Boxborough site—a new 250k ft2 development and manufacturing facility retrofitted to expand ReciBioPharm’s MA operations. He has spent the bulk of his career working on large greenfield and brownfield projects, focused heavily on project management, equipment procurement, automation and CQV. Including and prior to his time at ReciBioPharm, Forrest has successfully developed and implemented risk-based CQV strategies to streamline operational readiness and lower overall project costs.