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In a rapidly evolving industry where new technologies, shorter time-to-market, and multiproduct facilities are prevalent, organizations must transition to a science and risk-based approach to commissioning and qualification in order to maintain a compliant and efficient program.
This combination of presentations and a discussion panel seeks to explore the approaches and implementations of a risk based C&Q program for various types of pharmaceutical facilities to demonstrate they are fit for their intended purpose. The panelists will discuss the tactics their own organizations have taken in adopting integrated, compliant, science and risk based approaches towards qualification of systems, utilities, and equipment. A Q&A portion will follow the initial presentations and allow for the audience to pose questions to experts about current industry best practices for commissioning and qualification.
With the recent release of the ISPE Baseline Guide: Commissioning and Qualification Second Edition, this panel event aims to highlight the latest practices in the new Guide. The newest ways to implement a science and risk-based approach in a changing landscape will be identified.
Location: Takeda Fortis Lecture Hall 200 Shire Way Lexington, MA 02421
Program Schedule: Registration and Reception: 5:30 - 6:30 Introductions: 6:30 - 6:40 Panel Discussion + Q&A: 6:40 - 8:30
Speakers: Moderator: Nicola Mootoo, Manager, Quality-Validation, Takeda Nicola been with the company for 11 years in Validation and Quality-Validation roles. She has led in a number of successful remediation, integration and continuous improvement initiatives and has passion for mentoring, developing her team and relationship building. Outside of work, she enjoys watching Bruins Hockey and spending time with family and friends.
Panelists: Kathleen Bellorado, Validation Technology Manager, Pfizer Kathleen Bellorado is the Site Validation Manager at Pfizer in Andover, Massachusetts. She has over 18 years of experience in multi-product biopharmaceutical commercial and clinical manufacturing as well as validation industry. As the Site Validation Manager, she leads a team of engineers and scientists performing equipment validation, cleaning validation, in-process hold time solution categorization, disposable single-use technology, shipping validation, instrument validation, computer system validation, and utilities validation for the site. Kathleen also participates in numerous industry organizations. She holds a Bachelor of Science degree in Biology and a Master’s degree in biology and Biotechnology.
Emily Petrelis, Validation Projects & Systems Leader, Thermo Fisher Scientific Emily Petrelis, has over 22 years of experience in pharmaceutical and biotechnology commissioning, qualification, and validation. She is currently responsible for Equipment, Facility, and Utility qualification for all Global projects including the C&Q program within the Viral Vector Services of Thermo Fisher Scientific. Emily is currently involved in updating the global commissioning and qualification program within Viral Vector Services in effort to move to an ASTM E2500 based C&Q methodology from a CMO standpoint utilizing the new Baseline Guide 5.
Adam Hall, Senior Manager of QA Validation, Lonza Biopharma Adam Hall is Sr. Manager of QA Validation at Lonza Biopharma, accountable for equipment, cleaning and computerized system validation programs at the Portsmouth, NH manufacturing facility. Adam has 18 years of experience in commissioning and qualification in the biopharmaceutical industry, inclusive of parenteral, biotech, and cell and gene therapy technologies. Adam holds a BA from the University of New Hampshire and a Six Sigma Green Belt from American Society for Quality.
Aaron Jordan, Global Biologics Engineering Commissioning and Qualification Lead, Sanofi Aaron Jordan has over 19 years of industry experience which includes equipment commissioning and qualification as well as computer system validation within the biopharmaceutical sector. He joined Sanofi’s Global Engineering group in 2017 as the CQV Lead tasked with the oversight of CQV activities for the company’s new continuous manufacturing plant in Framingham. There he led the deployment of a new paperless validation tool and serves as the technical system owner as its adoption expands within Sanofi. Aaron is currently leading CQV activities for the expansion of Sanofi’s new facility in Framingham. Aaron’s experience with paperless validation began at Biogen where he assisted with its deployment, integration, and continued use across the company’s multinational network. Aaron holds a bachelor’s degree in chemical engineering from Worcester Polytechnic Institute and a master’s in business administration from Northeastern University.
Registration Fees: Early Bird (Ends 11/7/2019) Member: $50 Non-Member: $95 ISPE Young Professionals Member: $20 ISPE Student Members: FREE
After 11/7/2019 Member: $60 Non-Member: $115 ISPE Young Professional Member: $30 ISPE Student Members: FREE
Meeting Managers: Michelle Wang, Takeda Jack Campion, The Hart Companies Robert Beane, Barry-Wehmiller Design Group