Validation University Speaker

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52 search results for:

Sanjay Agrawal

August 10, 2020/in CSV - December 7-9, Faculty GMP University, Laboratory University OCT 5-7, Validation University Speaker

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.

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)

David W. Vincent

July 17, 2020/in Aseptic training 22 speaker, Biopharmaceutical Manufacturing 2021, CLEANING VALIDATION & CRITICAL CLEANING PROCESSES, CSV - December 7-9, Editorial Advisory Board, Faculty GMP University, LAB U 2022 Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, Validation University Speaker

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

Fred Ohsiek

July 17, 2020/in Cleaning University 2021 Speakers, CLEANING VALIDATION & CRITICAL CLEANING PROCESSES, Faculty GMP University, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, Validation University Speaker, z Cleaning Validation 2023 Speakers

Fred Ohsiek, Cleaning Validation Expert

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.

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.