Puerto Rico 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

Gerardo Gomez

July 17, 2020/in Faculty GMP University, Puerto Rico Speakers, Validation & GMP 2021 Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, Validation University Speaker

Senior Business Development Manager, ECHO Consulting Group,

Gerardo is a dynamic and accomplished leader, with over 25 years of experience in the Pharmaceutical and Biotechnology industries. He is recognized as a Subject Matter Expert in the areas of validations, technology transfer, investigations/CAPA systems, sterile product manufacturing, aseptic processes, and lyophilization. Gerardo has held positions at senior manager and director levels, complimenting his solid technical and scientifi c background with his natural people skills to effectively lead people and teams to success. Gerardo is known for his superb communications skills – both during public presentations and in writing – skills that he has used to consistently motivate people to action during ambitious and challenging projects. Gerardo graduated Magna Cum Laude from the Chemical Engineering department at the University of Puerto Rico, and later earned his Ph.D. in Pharmaceutics from the University of Michigan.

Tara Scherder

July 17, 2020/in Faculty GMP University, GMP U 2022 Speaker, Puerto Rico Speakers, Statistics in Validation, Val GMP Europe 2022, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, Validation University Speaker, ZZZZ - Lab U - Speaker

Partner, SynoloStats, LLC

Tara has over 25 years of experience in the chemical and pharmaceutical industries as a statistician, process engineer, and master black belt. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams across the product lifecycle for the spectrum of product platforms. As partner at SynoloStats, she passionately shares the opportunity for patient and business benefit through the combination of statistics and process. Tara earned a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University.

Chinmoy Roy

July 17, 2020/in 2024 - lean Validation, CSV - December 7-9, CSV / CSA 2022- Speaker, Laboratory University OCT 5-7, Puerto Rico Speakers, Val U 2023 speakers, Validation & GMP 2021 Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, zz GxP Technology Summit 2023 - Speaker, zzz CSV University 2023 Speakers, zzzz Validation university Speakers

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.

Jason Kelly

July 17, 2020/in Cleaning University 2021 Speakers, Faculty GMP University, Puerto Rico Speakers

Vice President Of Services, Lighthouse Worldwide Solutions

Jason Kelly is Vice President of Services at Lighthouse Worldwide Solutions and is based in Oregon. He has over 20 years of experience in providing Monitoring Solutions to the Cleanroom Industry and specializes in Pharmaceutical, Medical Device, Life Science, Semiconductor, Aerospace and Military Cleanroom applications. Jason presents worldwide on current cGMP and Environmental Monitoring Systems from risk management, system design, GAMP protocols, system installation, validation, customer training and system service support.

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).