Faculty GMP University

New Search

If you are not happy with the results below please do another search

39 search results for:

Dr. Ronald D. Snee

July 17, 2020/in 2023 GMP University Speakers, Analytical 2021, Faculty GMP University, Lab DI 2021, Lab U 2021 Speaker, LAB U 2022 Speaker, Laboratory University OCT 5-7, Puerto Rico Speakers, Statistics in Validation, Validation & GMP 2021 Speaker, VALIDATION UNIVERSITY EUROPE - Dec. 1-3, ZZZZ - Lab U - Speaker

Founder And President, Snee Associates, LLC

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.

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.

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.