David Vincent

Background

About David Vincent

Dr. Vincent has over thirty-three (33) years of 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]). Dr. Vincent has B.Sc.(industrial microbiology), Master Public Health (Specializing in Public Health Promotion), and Ph.D.(Doctorate Specializing Epidemiology). 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. Dr, Vincent is especially strong in the areas of Upstream and Downstream Process Development and Validation and developing and implementing Cleaning Validation, 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-seven (27) years providing validation and quality consulting services to various national and international companies, including project management and project execution services. Dr. Vincent is an ASTM committee member for the following guidance: • 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, • WK69826 - Standard Template for Environmental Monitoring Trend Analysis and • WK77957 - New Guide for Standard Guide for Cleanroom Gowning. • WK78574 - Best Practices for Microbial Control for Cell Therapeutics Dr. Vincent has 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.