Cleaning University 2021 Speakers

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

Jason Kelly

July 17, 2020/in Cleaning University 2021 Speakers, Faculty GMP University, Puerto Rico Speakers

Vice President Of Services, Lighthouse Worldwide Solutions

Jason Kelly is Vice President of Services at Lighthouse Worldwide Solutions and is based in Oregon. He has over 20 years of experience in providing Monitoring Solutions to the Cleanroom Industry and specializes in Pharmaceutical, Medical Device, Life Science, Semiconductor, Aerospace and Military Cleanroom applications. Jason presents worldwide on current cGMP and Environmental Monitoring Systems from risk management, system design, GAMP protocols, system installation, validation, customer training and system service support.

Fred Ohsiek

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Fred Ohsiek, Cleaning Validation Expert

Chip Bennett

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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.

Shelley Preslar

July 17, 2020/in Cleaning University 2021 Speakers, CLEANING VALIDATION & CRITICAL CLEANING PROCESSES, Faculty GMP University

President, Azzur Training Center

Shelley serves as President of the newly established Azzur Training Center (ATC) in Raleigh, NC, where she leads a team dedicated to providing comprehensive and customizable cGMP training. Prior to founding ATC, Shelley was the managing partner of Azzur Group Raleigh, which she opened in 2014 and built to a team of 30 specializing in consulting services across the product lifecycle in life sciences. Shelley has more than 20 years of FDA-regulated industry experience that includes time spent in both operating companies and consulting companies. She currently serves in several positions with PDA including being an Interest Group Leader, a member in Meeting Planning Committees, and co-chair on two technical documents related to aseptic processing and isolator design prepared to publish in 2020. Shelley holds a BS in Marine Biology from the University of North Carolina at Wilmington and an MBA in Global Management from the University of Phoenix. She is also a proud veteran of the U.S. Army and U.S. Marine Corps.