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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 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).
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.
Dr. Peju Odunusi is an analytical R&D professional with over 25 years of experience in the pharmaceutical and medical device industries. She has extensive analytical and CMC expertise in product development from inception to launch, with emphasis on “doing it right” the first time. She has successfully established analytical and stability groups in the course of her career, participated in numerous audits and is very passionate about mentoring.
Mr. LaPierre is an industry expert and an experienced data integrity project manager. He has a thorough understanding of not only the foundation and principles of data integrity but also the project management tools and resources needed to execute a truly effective data integrity program in the life science industry.
Steven S. Kuwahara, Ph.D., is principal consultant at GXP BioTechnology, LLC (www.gxpbiotech.org) in Sunnyvale, CA. Steve has more than 30 years experience supervising quality control department dealing with drugs, biologics, HCT/P, and nutraceuticals. He has supervised animal facilities and testing laboratories that operated under GLP rules and also those operating under GMP and ISO standards. He may be reached by e-mail and by phone at 408-530-9338.
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.