VALIDATION UNIVERSITY EUROPE - Dec. 1-3

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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.

Peju Odunusi

July 17, 2020/in Analytical 2021, Faculty GMP University, Lab DI 2021, Lab U 2021 Speaker, Laboratory University OCT 5-7, VALIDATION UNIVERSITY EUROPE - Dec. 1-3

Owner, Pj Pharmceutical Consulting

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.

Dennis Plante

July 17, 2020/in Faculty GMP University, Puerto Rico Speakers, VALIDATION UNIVERSITY EUROPE - Dec. 1-3

Senior Validation Market/Product Specialist, Amphenol / Kaye Instruments

Dennis Plante is the Senior Validation Market/Product Specialist for Kaye instruments located in Billerica MA. With his engineering background and his 39 years with Kaye Intruments serving the Pharmaceutical and Biotech industry, Dennis has a deep understanding of the practical applications of Wired and Wireless technologies and their applications related to Thermal Validation.

James Mason

July 17, 2020/in Faculty GMP University, Val U 2023 speakers, VALIDATION UNIVERSITY EUROPE - Dec. 1-3

PharmD, Compliance Officer, OPQO, U.S. FDA

James Mason received his Doctor of Pharmacy degree in 2006 and then served as an officer in the U.S. Air Force. In 2009, he was Commissioned as an officer in the U.S. Public Health Service and began working for FDA as a Field Investigator (CSO) conducting domestic and international drug GMP inspections. In 2016, he became a Pharmaceutical Specialist and now serves as a Compliance Officer for the Office of Pharmaceutical Quality Operations in Parsippany, NJ, where his primary responsibility is handling violative pharmaceutical inspections for FDA regulatory actions. He is a Board Certified Sterile Compounding Pharmacist (BCSCP) and Pharmaceutical GMP professional (ASQ CPGP).

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.

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.

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.

Senthil Gurumoorthi

July 17, 2020/in CSV - December 7-9, CSV / CSA 2022- Speaker, CSV Faculty, Faculty GMP University, Validation & GMP University Canada 2022 - Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3

MS MBA, Associate Director IT, Gilead Sciences

Senthil Gurumoorthi leads IT Quality Assurance function at Gilead Sciences, which provides independent oversight for GxP IT Infrastructure & Platforms and manages IT Inspection and audit readiness program. He has over 16 years of diverse experience in biopharmaceutical business ranging from pre-clinical, R&D to manufacturing with leadership expertise on Quality Assurance, Risk Management, Inspection/Audit Management, and Vendor Management. Additionally, as certified Auditor conducted ISO and Part 11/Annex 11 Audits globally. He holds B.E in Electronics & Communication from PSG College of Technology, MS in Electrical Engineering from New Jersey Institute of Technology and Masters in Business Administration (MBA) from Imperial College London.

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.