Dr. David W. Vincent, US

Dr. David W. Vincent, US
Chief Scientific Officer

Dr. Vincent has over 34 years of experience in the healthcare industry specializing in the Biotechnology and pharmaceutical industries. He has over 29 years dedicated to the field of Commissioning, Qualification, and Validation (CQV) 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. He is solid in the areas of Upstream and Downstream Process Development and Validation as well as developing and implementing Cleaning Development and 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, Pharmaceutical, Nutraceutical, and biological industries.

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, Best Practices for Microbial Control of ATMP, and Cleaning Quality by Design, and Risk-Based Cleaning. He also co-authored the ISPE GUIDE: Cleaning Validation Lifecycle – Applications, Methods & Controls.

He taught at San Diego State University (SDSU) for their Masters of Regulatory Affairs Degree program in the Field of Validation Technology RA-776.

Inducted into Delta Omega Honorary Society in Public Health was founded in 1924 at Johns Hopkins University within the School of Hygiene and Public Health to promote the graduate study of public health, and to recognize outstanding achievement in the new field.

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