David W. Vincent

VTI Life Sciences, Inc.
Dr. Vincent has over thirty-three (33) years’ experience in the health care industry specializing in the Biotechnology and pharmaceutical industries. He has over (26) twenty-six years dedicated to the field of validation (commissioning and qualification [C&Q]). He has B.Sc. degrees in industrial microbiology, as well as a Master of Public Health and Ph.D. He has hands-on experience in many areas of Regulatory Affairs, Quality Assurance, Commissioning/Qualification, and Engineering including regulatory submission preparation, Cleanroom Design Review, Microbiology Laboratory setup and qualification, Cleaning/Process Validation, Project Management, Utility and Process FAT/SAT Commission Plans, and Equipment Qualification implementation. He is especially strong in the areas of Upstream and Downstream Process Development and Validation as well as developing and implementing Aseptic Process and Environmental Monitoring Programs. Most of his career has been in the Biological vaccine industries but he has also supported the Medical Device, Biopharmaceutical, and Biological industries.

Dr. Vincent has spent the last twenty-five (25) years providing validation and quality consulting services to various national and international companies, including both project management and project execution services. Dr. Vincent is an ASTM committee member for Manufacture of Pharmaceutical and Biopharmaceutical Products - E55 (20-07), Microbial/Sterility Assurance for Pharmaceutical and Biopharmaceutical Products - E55.06 (20-01), WK74412 - New Standard Critical Airflow Visualization, and WK69826 - Standard Template for Environmental Monitoring Trend Analysis. He also coauthored the ISPE GUIDE: Cleaning Validation Lifecycle – Applications, Methods & Controls.

He is responsible for managing and supporting many different product launches. He teaches at San Diego State University (SDSU) for their Masters of Regulatory Affairs Degree program in the Field of Validation Technology RA-776.