Validation & GMP 2021 Speaker

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Ken Shitamoto

July 17, 2020/in CSA Training Speaker, CSV - December 7-9, CSV / CSA 2022- Speaker, Faculty GMP University, Val U 2023 speakers, Validation & GMP 2021 Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, Validation University Speaker, zzz CSV University 2023 Speakers, ZZZ Singapore Speakers

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.

Roque Redondo

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

VP Business Development Automation, Mirus Consulting Group Corp

Mr. Roque Redondo has close to 30 years of experience including international experience in the validation, QA, engineering, compliance and regulatory affairs in the life science environment. He was part of the senior management team during the implementation of the remediation activities related to Schering-Plough Consent Decree. His experience includes Data Integrity, operations, serialization, validation, QA, engineering and technical services. Mr. Redondo has attended to over 10 different courses related to Data Integrity as well as he has written 5 articles related to this topic. He has a nice blend of experience, including process and cleaning procedures, that help him understand the importance of manufacturing operations without jeopardizing the quality of the products with strong management skills.

Matthew LaPierre

July 17, 2020/in Analytical 2021, CSV - December 7-9, CSV / CSA 2022- Speaker, Editorial Advisory Board, Faculty GMP University, Lab DI 2021, Lab U 2021 Speaker, LAB U 2022 Speaker, Lab U 2023 Speakers, Laboratory University OCT 5-7, Puerto Rico Speakers, Val GMP Europe 2022, Validation & GMP 2021 Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, zzz CSV University 2023 Speakers, zzzz Validation university Speakers

Data Integrity Specialist, Jackson Scott Consulting

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 Kuwahara

July 17, 2020/in Analytical 2021, Faculty GMP University, Lab DI 2021, Lab U 2021 Speaker, Laboratory University OCT 5-7, Stability 2021, Validation & GMP 2021 Speaker

Principal Consultant, GXP BioTechnology, LLC

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.

Philip Jarvis

July 17, 2020/in Faculty GMP University, Val GMP Europe 2022, Val U 2023 speakers, Validation & GMP 2021 Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, Validation University Speaker, ZZZ Val U Amsterdam Speakers

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

July 17, 2020/in 2023 GMP University Speakers, Analytical 2021, Faculty GMP University, GMP U 2022 Speaker, Lab DI 2021, Lab U 2021 Speaker, LAB U 2022 Speaker, Lab U 2023 Speakers, Laboratory University OCT 5-7, Product Complaints 23 Speaker, 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 Speaker, zzz CSV University 2023 Speakers, ZZZ Val U Amsterdam Speakers, ZZZZ - Lab U - Speaker

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

July 17, 2020/in 2023 GMP University Speakers, Editorial Advisory Board, Faculty GMP University, GMP U 2022 Speaker, Puerto Rico Speakers, Val GMP Europe 2022, Val U 2023 speakers, Validation & GMP 2021 Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, Validation University Speaker, zz Med Device Speakers, ZZZ Val U Amsterdam Speakers, zzzz Validation university Speakers

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.

Alan M Golden

July 17, 2020/in Faculty GMP University, GMP U 2022 Speaker, Puerto Rico Speakers, Validation & GMP 2021 Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, zz Med Device Speakers

Principal, Design Quality Consultants

Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations. Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.

Danielle Duran

July 17, 2020/in 2023 GMP University Speakers, CSV - December 7-9, CSV / CSA 2022- Speaker, Faculty GMP University, GMP U 2022 Speaker, Val GMP Europe 2022, Validation & GMP 2021 Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, Validation University Speaker

Senior Manager, Training And Development, Site Bus, BioMarin Pharmaceutical

Danielle has worked in learning and continuous improvement program management in biotechnology, tech-startups, k-16 education, philanthropy, and non-profit. Her expertise is leveraging an understanding of how learning is understood from a neurological perspective combined with how we understand behavior and social interactions to drive meaningful change. Danielle has provided leadership to a research team investigating the use of varied sets of data to predict human performance and a team developing and validating very large-scale knowledge assessments to predict performance. She has also taught assessment design at the graduate level. She is currently leading a global initiative to improve aspects of the training system, standards, and procedures. She enjoys learning, supporting the meaningful development of others, and advising leaders on how to catalyze their talent.

Chip Bennett

July 17, 2020/in Cleaning University 2021 Speakers, CLEANING VALIDATION & CRITICAL CLEANING PROCESSES, Faculty GMP University, GMP U 2022 Speaker, Puerto Rico Speakers, Val GMP Europe 2022, Val U 2023 speakers, Validation & GMP 2021 Speaker, Validation & GMP University Canada 2022 - Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, Validation University Speaker, ZZZ Singapore Speakers, ZZZ Val U Amsterdam Speakers

Assistant Director, CAI

Chip Bennett, Assistant Director, Global C&Q, CAI is a QRM SME and lead CQV Program Development SME. A Project Manager and Senior Validation Engineer, Chip is a PMI® Certified Project Management Professional (PMP) with 20 years of experience in the pharmaceutical and regulated non-pharmaceutical industries and with expertise in risk-based verification, aseptic manufacturing, cleaning validation, quality systems, and owner project management. Chip is responsible for developing and implementing Quality Risk Management (QRM) based Commissioning and Qualification programs and projects, with a particular focus on assessing and training clients regarding development, implementation, and transition to risk-based approaches.