Validation & GMP 2021 Speaker

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.

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.

Steven Thompson

July 17, 2020/in 2023 GMP University Speakers, Analytical 2021, CSA & part 11 2023 - Speakers, CSA Training Speaker, CSV - December 7-9, Faculty GMP University, Lab DI 2021, Lab U 2021 Speaker, Laboratory University OCT 5-7, Val U 2023 speakers, Validation & GMP 2021 Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, Validation University Speaker, zz GxP Technology Summit 2023 - Speaker, zz Med Device Speakers

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

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).

Dr. Ronald D. Snee

July 17, 2020/in 2023 GMP University Speakers, Analytical 2021, Faculty GMP University, Lab DI 2021, Lab U 2021 Speaker, LAB U 2022 Speaker, Laboratory University OCT 5-7, Puerto Rico Speakers, Statistics in Validation, Validation & GMP 2021 Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, ZZZZ - Lab U - Speaker

Founder And President, Snee Associates, LLC

Ron Snee is Founder of Snee Associates, LLC, a firm dedicated to the successful implementation of process and organizational improvement initiatives, using Quality by Design, Lean Six Sigma and other improvement approaches. He is also an Adjunct Professor in the RAQA and pharmaceutical programs at Temple and Rutgers Universities. Prior to entering the consulting field he worked at DuPont for 24 years in a variety of assignments including pharmaceutical development. He is an Honorary Member of the American Society for Quality and has received numerous honors and awards for his research, consulting and publications.