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Gerardo Gomez
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.
William T. Drummond Jr.
Director, Global Computer Validation Quality Assurance, Charles River Laboratories
William is currently the Director, Global Computer Validation Quality Assurance, at Charles River Laboratories. His responsibilities include managing and coordinating multi-business unit computer system validation (CSV) projects, quality assurance (QA) oversight of corporate IT, data integrity improvement, training, vendor audits, and internal audits. Besides his current role, he has worked in the biopharma industry since 2000 as a systems integrator and a CSV and QA consultant. He is a retired U.S. Army Lieutenant Colonel whose career included positions with various field artillery units and computer systems development project management offices. He has a Master of Science in Computer Science, concentrating in Artificial Intelligence, from the U.S. Naval Postgraduate School and a Bachelor of Science from the U.S. Military Academy at West Point, NY.
Tara Scherder
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.
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)
David W. Vincent
CEO, 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
Jason Kelly
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.
Fred Ohsiek
Fred Ohsiek, Cleaning Validation Expert
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).