ZZZ Singapore Speakers

David Vincent has over thirty-two (32) years’ experience in the health care industry specializing in the Biotechnology and pharmaceutical industries. He has over (20) twenty years dedicated to the field of validation (commissioning and qualification [C&Q]). He has B.Sc. degrees in industrial microbiology, B.Sc., Mechanical Engineering Technology, Master and PhD in Public Health. He has hands on experience in many areas of Regulatory Affairs, Quality Assurance and Commission/Qualification, Engineering including; regulatory submission preparation, Design Review, Microbiology Laboratory setup and qualification, Construction Qualification, Project Management, Utility and Process FAT/SAT Commission Plans, and Equipment Qualification implementation. He is especially strong in the areas of Process Development and Validation, Cleanroom design and management as well as developing and implementing Aseptic and Environmental Monitoring Programs. Most of his career has been in the Biological vaccine industries but also support medical devices, biotechnology and pharmaceutical industries

Raul Soto

July 17, 2020/in 2023 GMP University Speakers, Analytical 2021, CSV - December 7-9, CSV / CSA 2022- Speaker, Faculty GMP University, Lab DI 2021, Lab U 2021 Speaker, LAB U 2022 Speaker, Laboratory University OCT 5-7, Puerto Rico Speakers, Stability 2021, Val GMP Europe 2022, Val U 2023 speakers, Validation & GMP 2021 Speaker, Validation & GMP University Canada 2022 - Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, zz Med Device Speakers, ZZZ Singapore Speakers, ZZZ Val U Amsterdam Speakers, zzzz Validation university Speakers

Sr. Principal Software Engineer, Johnson & Johnson

Raul Soto is a Senior Principal Software Engineer at Johnson & Johnson Vision Care (JJVC), focused on Computerized Systems Validation and Software Quality Engineering. Mr. Soto has over 20 years of experience in validation, process engineering, industrial automation, and software quality; and has held positions of increasing responsibilities in the medical devices, biotechnology, pharmaceutical, and consumer electronics industries. Raul has led multiple global and site projects in the United States, Europe and China. As an invited speaker he has lectured on computer systems validation, data integrity, statistics, PLC/SCADA automation, and quality/compliance issues at various conferences in the United States and Europe. Raul has an MS degree in Biotechnology with emphasis on Biomedical Engineering, and a BS degree in Mechanical Engineering. He is also an ASQ Certified Quality Engineer (CQE).

Ken Shitamoto

July 17, 2020/in CSA Training Speaker, CSV - December 7-9, CSV / CSA 2022- Speaker, Faculty GMP University, Val U 2023 speakers, Validation & GMP 2021 Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, Validation University Speaker, zzz CSV University 2023 Speakers, ZZZ Singapore Speakers

MS, Sr. Director IT, Gilead Sciences

Ken Shitamoto leads the IT quality engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, and software development. He has been in the biopharmaceutical space since 1993 and has worked both on the manufacturer, vendor, and consulting sides of the business. Additionally, he has also performed over 100 GXP computer systems compliance audits globally. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association, and Ken and his daughter have raised over 130K dollars to fight lung disease.

Chip Bennett

July 17, 2020/in Cleaning University 2021 Speakers, CLEANING VALIDATION & CRITICAL CLEANING PROCESSES, Faculty GMP University, GMP U 2022 Speaker, Puerto Rico Speakers, Val GMP Europe 2022, Val U 2023 speakers, Validation & GMP 2021 Speaker, Validation & GMP University Canada 2022 - Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, Validation University Speaker, ZZZ Singapore Speakers, ZZZ Val U Amsterdam Speakers

Assistant Director, CAI

Chip Bennett, Assistant Director, Global C&Q, CAI is a QRM SME and lead CQV Program Development SME. A Project Manager and Senior Validation Engineer, Chip is a PMI® Certified Project Management Professional (PMP) with 20 years of experience in the pharmaceutical and regulated non-pharmaceutical industries and with expertise in risk-based verification, aseptic manufacturing, cleaning validation, quality systems, and owner project management. Chip is responsible for developing and implementing Quality Risk Management (QRM) based Commissioning and Qualification programs and projects, with a particular focus on assessing and training clients regarding development, implementation, and transition to risk-based approaches.