Tag

QA/QC

Proactivity – the Future of Quality
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Proactivity – the Future of Quality

Dr Mire-Sluis is currently Head of Global Quality at AstraZeneca. He was previously Vice President, North America, Contract, Singapore and Product Quality at Amgen Inc. Prior to working at Amgen, he was Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego.

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Building a Leading Quality Management Framework
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Building a Leading Quality Management Framework

Karin Ann Payne is the Vice President of Corporate Quality in BMS.

In this role, Karin provides strategic quality and compliance leadership in the GxP development and implementation of an integrated QMS across the Enterprise including Research and Early development, Global Drug Development, Global Product and Supply and Medical Affairs and in support of the product lifecycle.

Prior to joining BMS she was the VP of NA Quality for Bayer where she was responsible for ensuring that Bayer remained committed to the highest standards of quality, which is paramount to the patients and customers it serves every day. She joins Bayer from Reckitt Benckiser, where she most recently held the role of Head of Global Corporate Quality Compliance. In this role, she was responsible for managing the company’s Global Quality Management System, Corporate Quality audits, and its Global metrics and Computer System Validations teams. She also managed the Europe and North America Commercial Quality teams, responsible for managing market quality. Prior to that, she held a variety of roles in Quality Assurance and Compliance including positions at Actavis and Pfizer, managing the unique challenges and opportunities of both the consumer health and pharmaceutical industries.

She holds an MLS in Pharmaceutical law (High Honors) from Seton Hall, MBA in Financial Management (High Honors) with a Certificate in International Finance from Iona University and a Bachelor’s in Biological Sciences from Rutgers University.

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John H. Adams, Jr. of Spark Therapeutics — Computer Software Assurance for Biopharmaceutical Manufacturers
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

John H. Adams, Jr. of Spark Therapeutics — Computer Software Assurance for Biopharmaceutical Manufacturers

At the 2024 edition of the Biomanufacturing World Summit series we sat down with John H. Adams, Jr., Spark Therapeutics’ Senior Director, Validation, to talk about Computer Software Assurance in the Life Sciences. John has been doing Computer Systems Validation (CSV) for decades as a regulatory requirement, so when talk of a risk-based Computer Software Assurance (CSA) requirement started making the rounds, he was interested to understand the differences so he could best stay ahead of the compliance curve and ensure his best practices were not out of step with expectations. In this episode, John walks us through where the conversation between industry and regulators currently stands, what validation professionals should already be doing, what they should continue to do, what they should confirm they are doing correctly, and what they should prepare themselves for if and when current guidance becomes new regulations. For everyone in the Life Sciences who cares about the compliance of manufacturing systems, give this episode a listen!

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Driving Transformation in Quality to Meet the Needs of Our Customers
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Driving Transformation in Quality to Meet the Needs of Our Customers

A relentless visionary, Robin Kumoluyi consistently moves people and organizations forward. Throughout her career, she has expertly crafted complex quality management strategies for multi-billion-dollar matrixed organizations. Committed to the belief that patients and customers must have access to effective medicine, Robin intentionally chose the quality function within the pharmaceutical indutry.

Robin Kumoluyi is the Vice President and Chief Quality Officer, Pharmaceuticals at Johnson & Johnson Corporation. Robin has responsibility for Quality & Compliance for the Global Pharmaceuticals Segment in Pre-Market R&D, Supply Chain and Post Market Commercial. Prior to her current role, Robin was VP, Global Quality Services at Johnson & Johnson, where she drove the organization’s Enterprise Quality transformation by defining, leading, and executing the strategic direction and oversight of the Quality Policies, Standards, Digital Healthcare, Innovation and Analytics, Value Chain Quality, and the overall Q&C Strategy and associated processes.

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Issues, Trends, Excitement, and Great News for Pharmaceutical Manufacturers — A Conversation with Teresa Gorecki of Compliance Architects
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

Issues, Trends, Excitement, and Great News for Pharmaceutical Manufacturers — A Conversation with Teresa Gorecki of Compliance Architects

At the 2024 edition of the Pharma Manufacturing World Summit we sat down with Teresa Gorecki of Compliance Architects to speak with enthusiasm and optimism about the future of medicine, the most recent developments and what they mean for patients, but especially the most recent ideas and information pharmaceutical manufacturers and other senior leaders in the Life Sciences need to know as the industry moves forward together into a very exciting time. What are some of the top-of-mind challenges and opportunities pharma manufacturers are dealing with right now, and how are the early adaptors already addressing those issues? How are regulators working with industry to improve end results for patients? How is commercialization of ATMPs progressing, and what can we all learn from the first examples coming online now? For all this and more, give this episode a listen!

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Fireside Chat: Advancing the Production System
MANUFACTURING, VIDEO, MANUFACTURING

Fireside Chat: Advancing the Production System

Paisley Matthews is the Vice President of Manufacturing and Safety for Boeing Defense, Space and Security and a member of the Boeing Manufacturing Operations Council. In these roles, she is responsible for ensuring the Defense, Space & Security production system consistently operates in an integrated, lean and effective manner. In this session, Paisley will discuss integrating data visualization tools for better process visibility, as well as implementing Six Sigma methodologies to reduce defects, enhance product quality, and optimize processes for consistent outputs.

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Real-Time Visibility for FSQ Professionals — A Conversation with Julie McGill of Trustwell
FOOD SAFETY & QUALITY, VIDEO, FOOD SAFETY & QUALITY, PODCAST

Real-Time Visibility for FSQ Professionals — A Conversation with Julie McGill of Trustwell

At North American Food Safety & Quality 2023 we sat down with Julie McGill of Trustwell to talk about one of the most exciting tools available to Food Safety and Food Quality professionals: Real-Time Visibility tools that can connect people directly and precisely to produce, products, and goods at any point in the journey from origin point to point of sale to the final customer. Things that would have seemed like science fiction even ten years ago are now everyday tools, and the best is still yet to come. This is creating a revolution in Risk Management, Waste Reduction, Recall Planning, QA/QC, and also connects the FSQ team to other facets of the business to share data and incorporate them into decision-making processes that did not use to include them. Being able to move from reactive to proactive without increasing headcount sounds too good to be true, but it is happening right now thanks to real-time visibility. Give this episode a listen to learn more!

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