Douglas Brown, Sr. Scientist, Charles River Laboratories
Experienced Scientist with a demonstrated history of working in the biotechnology industry. Skilled in Radiation Safety, Bioinformatics, Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), Real-Time Polymerase Chain Reaction (qPCR), and Method Qualifications and Validations. Strong research professional with a Doctor of Philosophy (Ph.D.) focused in Biochemistry and Molecular Biology from Thomas Jefferson University.
Taylor Dieringer, Staff Quality Engineer – Risk Management, iRhythm Technologies, Inc
Taylor Dieringer is an accomplished Staff Quality Engineer with a focus on risk management and regulatory standard compliance. With extensive knowledge of Quality Management Systems, statistical techniques, and risk management processes, Taylor has worked both in industry and as a consultant to develop quality systems that embed risk-based decisions into design control, process validation, and post-market surveillance procedures. Taylor holds a Bachelor of Science in Biomedical Engineering from the Milwaukee School of Engineering, and is certified as a Quality Engineer and Reliability Engineer by ASQ. Taylor is also pursuing a certificate in Medical Device Quality Design from the University of California, Santa Cruz. As a medical device risk management thought-leader, Taylor has presented at industry conferences including MedCon, ASQ Medical Device Division, and various KenX events.
Alan M Golden, 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.
Anne Greene, Head, Pharmaceutical Regulatory Science Team (PRST), Technological University Dublin
Anne Greene leads the Pharmaceutical Regulatory Science Team (PRST) in TU Dublin, where she is also a senior lecturer and director of the several MSc. and BSc. Pharmaceutical Programmes, including the TU Dublin MSc in Pharmaceutical Validation Technology. She has supervised several students to PhD awards in areas of Quality Risk Management, Knowledge Management, Operational Excellence and PAT. Prior to embarking on an academic career, Anne worked at a senior level for several years in the pharmaceutical sector in Validation and Technical Management roles. Anne has a PhD in Synthetic Organic Chemistry from University College Dublin, and is currently a member of committee of the Irish Chapter of PDA.
Anne is also on the Board of Directors of Regulatory Science Ireland (RSI) and is chair of the Corporate Development Committee
Senthil Gurumoorthi MS MBA, Security & Compliance Global Lead, Healthcare & Life Sciences – Amazon Web Services (AWS)
Senthil Gurumoorthi is the Global Lead of Healthcare & Life Sciences – Security & Compliance for Amazon Web Services. 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.
Philip Jarvis, Director Integrated C&Q and Paperless Strategy, Veqtor Solutions
After Completing an Honors degree in Chemical Sciences at the University of Salford ,Phil Joined J&J for his first 10 years in the Medical device industry mostly in Validation roles . Since then he has worked in validation /C&Q leadership roles at site and global levels for Various Pharma /Biopharma Companies including BioMarin, UCB, and AbbVie .
At AbbVie, Phil was responsible for the introduction of the Kneat paperless validation platform globally, he also developed and rolled out its risk based C&Q approach to the network .
He is currently the Director of integrated C&Q and paperless Strategy at Veqtor solutions.
Matthew LaPierre, 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.
Kevin Martin Managing Partner, Azzur Group
Kevin Martin serves as Managing Partner, Azzur Group, LLC and General Manager, Azzur Group IT. Kevin has more than 40 years of FDA-regulated industry experience that includes management positions at Wyeth and McNeil Pharmaceutical. He is currently a General Manager for Azzur IT and a member of the Azzur Group Board of Directors.
He was a member of the PhRMA Computer Systems Validation Sub-Committee (responding to the FDA’s issuance of the 1983 “Blue Book”), was the Core Team Secretary for the PDA Part 11 Task Group (working alongside FDA’s Paul Motise to develop industry guidance) and is a former Chair of the GAMP Americas and GAMP Global Steering Committees, and a contributor to several GAMP Good Practice Guides and Special Interest Groups.
Donncadh J. Nagle, Principle Validation Engineer
Donncadh J. Nagle is a pharmaceutical industry professional based in Ireland and is a recent graduate from the masters degree programme, MSc. in Pharmaceutical Validation Technology, at the Technological University Dublin (TU Dublin). Donncadh is an experienced Validation Engineer with over eleven years of experience in all areas of validation including; Process/Product Validation, Equipment/Automation Qualification, Facilities Qualification, Computer System Validation, Test Method Validation, and Cleaning Validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device and pharmaceutical industries. Donncadh has ambitions to become an industry leader within the pharmaceutical industry and is the current Chair of the BPCI Validation group, Ireland. Donncadh is also a recent winner of the 2018 Thesis award presented by KENX at their C&Q and Data Integrity conference, in Dublin, Ireland.
Donncadh is also a published author with IVT/JVT, USA
Fred Ohsiek, Senior Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North America
Fred Ohsiek is the Sr Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North America. His main focus at Ecolab is to assist customers with cleaning validation/cleaning challenges and cleaning process optimization.
He earned his bachelor’s in chemistry from University of South Florida.
His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 22 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Boehringer Ingelheim, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring of cleaning processes for equipment used in small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional product manufacturing.
The scope of his work involved drug substance and drug product manufacturing start-up; remediation and legacy justification; creating/improving routine monitoring programs; and increasing manufacturing capability. He has also introduced and incorporated methods to lean the CV footprint by reducing documentation and execution.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.
Lelia Scott, Executive Director, Global Quality Systems Charles River Laboratories
Ms. Scott is an executive management quality professional with 16 years of QA experience within the pharmaceutical industry and 7 years in analytical lab sciences. Specializations include: data integrity compliance, global process adoption, implementation of enterprise-wide quality systems, global computer system validation, laboratory systems, relationship building in cross-functional teams and development of innovative solutions to expedite business processes using electronic systems in compliance with global pharmaceutical regulations. Each of these programs is made successful through the development of innovative training solutions. Knowledge and experience in and US FDA and European GLP, cGMP, GCP and Animal Welfare regulatory compliance.
Ken Shitamoto MS, Sr. Director IT, Gilead Sciences
Ken 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.
David W. Vincent, MPH, Ph.D. CEO, VTI Life Sciences
Dr. Vincent has over thirty-three (33) years’ experience in the health care industry specializing in the Biotechnology and pharmaceutical industries. He has over (26) twenty-six years dedicated to the field of validation (commissioning and qualification [C&Q]). He has B.Sc. degrees in industrial microbiology, as well as a Master Public Health and Ph.D. He has hands on experience in many areas of Regulatory Affairs, Quality Assurance, Commissioning/Qualification, and Engineering including regulatory submission preparation, Cleanroom Design Review, Microbiology Laboratory setup and qualification, Cleaning/Process Validation, Project Management, Utility and Process FAT/SAT Commission Plans, and Equipment Qualification implementation. He is especially strong in the areas of Upstream and Downstream Process Development and Validation as well as developing and implementing Aseptic Process and Environmental Monitoring Programs. Most of his career has been in the Biological vaccine industries but he has also supported the Medical Device, Biopharmaceutical and Biological industries.
Dr. Vincent has spent the last twenty-five (25) years providing validation and quality consultant services to various national and international companies, including both project management and project execution services. Dr Vincent is ASTM committee member for Manufacture of Pharmaceutical and Biopharmaceutical Products – E55 (20-07), Microbial/Sterility Assurance for Pharmaceutical and Biopharmaceutical Products – E55.06 (20-01), WK74412 – New Standard Critical Airflow Visualization and WK69826 – Standard Template for Environmental Monitoring Trend Analysis. He also coauthored the ISPE GUIDE: Cleaning Validation Lifecycle – Applications, Methods & Controls.
He is responsible for managing and supporting many different product launches. He teaches at San Diego State University (SDSU) for their Masters of Regulatory Affairs Degree program in the Field of Validation Technology RA-776.
Dr. Kelly Waldron, Senior Consultant, ValSource
Dr. Kelly Waldron is currently a senior consultant with ValSource and a member of the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (formerly Dublin Institute of Technology) in Dublin, Ireland. She has particular expertise and a specialized focus on the development and implementation of innovative approaches to quality risk management (QRM) and has authored numerous industry and academic papers on the topic. Dr. Waldron’s expertise extends to various quality functions in the pharmaceutical, biopharmaceutical, and medical device industries, including quality system design, quality strategy and planning, deviations/investigations, CAPA, change management, data integrity, audit and inspection programs and response, and design control. She holds a BA in biology from Boston University, an MBA in pharmaceutical management from Fairleigh Dickinson University, and a Ph.D. in pharmaceutical regulatory science (thesis in QRM) from the Dublin Institute of Technology. She currently resides in New Jersey, USA and can be reached at firstname.lastname@example.org.