Vince Cebular

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.