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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 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 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.
Katherine has worked as a statistician in the Pharmaceutical industry for over 17 years and has expertise across the product lifecycle, from product and process development through validation and commercial supply, as well as all stages of clinical development from First in Human through licensure and beyond. She holds a Master of Statistics from North Carolina State University, with a focus in biostatistics. Katherine lives and works in the Philadelphia suburbs with her husband and daughter and 2 cats, and in her spare time is a dancer and a teacher of Scottish dancing.
Danielle has worked in learning and continuous improvement program management in biotechnology, tech-startups, k-16 education, philanthropy, and non-profit. Her expertise is leveraging an understanding of how learning is understood from a neurological perspective combined with how we understand behavior and social interactions to drive meaningful change. Danielle has provided leadership to a research team investigating the use of varied sets of data to predict human performance and a team developing and validating very large-scale knowledge assessments to predict performance. She has also taught assessment design at the graduate level. She is currently leading a global initiative to improve aspects of the training system, standards, and procedures. She enjoys learning, supporting the meaningful development of others, and advising leaders on how to catalyze their talent.
Dr. Anthony Chikere is an experienced Scientist with over 18 years of experience in different areas of Biopharmaceutical production including: process development, process monitoring and control, process validation and quality assurance at leading pharmaceutical companies including Johnson & Johnson, BioMarin, Grifols and Bayer. Since 2017, he is responsible for managing the Continued Process Verification (CPV) program at Bayer Pharmaceuticals, Berkeley, CA.
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.
Brent Gendleman is a technology executive who has spent more than 20 years leading innovation and design for technology solutions for the life science and healthcare industries. In early 2018, Brent came on board with Azzur Group as Senior Strategist for Innovation and Technology Adoption where he works hand-in-hand to unleash partners’ full potential with comprehensive IT Quality Strategic Roadmaps delivered through Azzur IT Advisory Services.In addition to his work with Azzur, Brent is a founder of 5AM Solutions, which developed Sunrise, a SaaS solution used by top 5 pharma for managing genomic, imaging, wearable, and medical device data. After serving as CEO from 2003 to 2014, he transitioned the company to a new chief executive and currently focuses on business development. A resident of Bethesda, Maryland, Brent holds a Bachelor of Science from Syracuse University, as well as professional certification from George Washington University.
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.
As Chief Technology Officer for Azzur Technology Consulting Services, Christopher (Chris) Robitaille is responsible for all technology projects the group delivers. Chris is a trusted advisor and subject matter expert for Azzur’s clients across a number of industries, including education, pharma/biotech, health, and manufacturing. With more than 30 years of experience, Chris is a trusted industry veteran. Before joining Azzur, he was the Director of Infrastructure Technology at a local college, managing a team of 14. He was responsible for large-scale IT transformation projects, such as data center forklift upgrades, cloud enablement, and migrations. Before that, he worked as a consultant on New York University’s Abu Dhabi campus data center project, as well as other enterprise endeavors at several Universities in the New York City area.