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David W. Vincent, MPH, Ph.D.
CSO (Chief Scientific Officer), MPH, PhD For VTI Life Science
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
Chinmoy Roy
Senior Industry Consultant, VALGENESIS
Chinmoy Roy is an experienced biopharmaceutical consultant with subject matter expertise in CSV, Data Integrity, CFR 21 Part 11, Annex 11 and manufacturing process automation systems. He is a member of ISPE’s Data Integrity Special Interest Group (S.I.G). His presentations blend his field experience to highlight the intricacies of implementing regulations. Chinmoy has a bachelor’s degree in Electrical Engineer and a Master’s degree in Computer Science.
Steven Thompson
Director Industry Solutions, VALGENESIS
Steve has worked in Life Sciences for over 20 years, has a Bachelor of Science degree in Computer Information Systems, served in both technical and quality roles. He’s a PDA certified auditor, has audited hundreds of companies globally, is a published author, and frequent speaker at conferences. Currently he’s Director of Industry Solutions for ValGenesis, Inc. (valgenesis.com)
Raul Soto
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
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.
James Mason
PharmD, Compliance Officer, OPQO, U.S. FDA
James Mason received his Doctor of Pharmacy degree in 2006 and then served as an officer in the U.S. Air Force. In 2009, he was Commissioned as an officer in the U.S. Public Health Service and began working for FDA as a Field Investigator (CSO) conducting domestic and international drug GMP inspections. In 2016, he became a Pharmaceutical Specialist and now serves as a Compliance Officer for the Office of Pharmaceutical Quality Operations in Parsippany, NJ, where his primary responsibility is handling violative pharmaceutical inspections for FDA regulatory actions. He is a Board Certified Sterile Compounding Pharmacist (BCSCP) and Pharmaceutical GMP professional (ASQ CPGP).
Philip Jarvis
Director Integrated C&Q and Paperless Strategy, Veqtor Solutions
Mr. Jarvis is an experienced team leader with over 20 years of experience in all areas of validation including; process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device / pharmaceutical / and biologics industries.
Kim Huynh-Ba
Managing Director, Pharmalytik
Kim Huynh-Ba is the Managing Director of Pharmalytik, LLC, a consulting and training organization. She has over 30-years of experience in Validation, Audits, Data Integrity, Quality Systems, CMC, Analytical Lifecycle, and Stability Sciences. She is a Council of Experts of US Pharmacopeia (2015-2025), where she chairs the Small Molecules IV Expert Committee. She is also a member of the USP Drug-Device Combination Products Sub-Committee. Kim is a former President and Distinguished Board Member of the Eastern Analytical Symposium (EAS). She is chairing the American Association of Pharmaceutical Scientists (AAPS) career committee and was named Fellow since 2020. Kim has served on various editorial boards such as AAPS Open and Pharmaceutical Chemistry Journal. Her extensive experience and involvement in various aspects of the pharmaceutical industry highlights her commitment to advance quality standards and best practices in the field.
Connie Hetzler
Global Head Of Validation, Alcon Laboratories
Ms. Hetzler has over 32 years of experience working in regulated consumer products and healthcare industry roles. In her current role as Global Head of Validation for Alcon, she is accountable for the validation strategy for 16 manufacturing sites including both the surgical and vision care divisions.