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By Beth Fulton, Patrick Mains, and Kelly Waldron, ValSource Inc. | Risk registers can be a valuable risk management tool, and having a risk register is increasingly becoming a regulatory expectation. It can be structured as a database or spreadsheet and ensures decision makers have key information about risks. This discussion also includes pitfalls to avoid. |
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By Allan Marinelli and Howard Mann | All drug delivery manufacturing systems undergoing quality improvement projects involve teams to gather many inputs and then to analyze the data. This article, the first in a three-part series, provides an overview and theoretical understanding of measurement system analysis using continuous gage repeatability and reproducibility (R&R) studies. |
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By Amnon Eylath, Broad Spectrum GXP Consulting | Painting mistakes with the broad human error brush ignores the underlying causes, which can be complex. Amnon Eylath, a veteran GMP consultant, presents a case study that illustrates why he encourages companies to adopt robust processes for uncovering true root causes and reducing deviations. |
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| Improve The Injection Experience In Chronic Care | Q&A | BD Medical - Pharmaceutical Systems | This series of frequently asked questions covers the research and design mindset applied to the development of the BD Neopak XtraFlow solution and the anticipated clinical benefits of 8 mm needles. |
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| Improving Efficiency In Upstream Process Development | Webinar | Cytiva | Explore the latest trends in cell culture technology, the tools and enablers for scale-up, strategies to accelerate cell line development, media development, raw material characterization, and more. |
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LIFE SCIENCE LEADER MAGAZINE |
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Have you heard of Life Science Leader? Check it out today for access to candid interviews with top-tier executives on how they do business. |
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