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31-45 of 79 results
NSF: Remediation of Pharma Quality Systems – It’s All About the People
| By NSF International
Much of NSF Pharma Biotech Consulting’s work involves helping companies remediate flawed quality systems. This is usually done as a result of threatened or actual enforcement action by regulatory agencies. In these circumstances, companies are desperate and willing to do ‘whatever it takes’ without a full understanding of what that means. While expansive in concept, ‘whatever it takes,’ for many, means simply deploying internal and external resources to design and document a new quality management system. This is a significant commitment by management in resources, but unless the cause (how did this happen?) is also considered, the effort is doomed to fail.
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Brexit Implications for UK Pharmaceutical Administration with NSF
| By NSF International
With the historic vote by the UK to leave the European Union we have been asked by many of our clients and colleagues “What will the vote to leave the EU (Brexit) mean for pharmaceutical quality management and the role of the Qualified Person (QP)?” The only thing that is certain is that we are facing at least two, and probably more, years of unprecedented uncertainty.
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NSF: Techniques to tackle our current Complexity Crisis
| By NSF International
Over the last 30 years we have seen levels of complexity in the pharma industry increase dramatically. It’s getting close to a crisis point. Although some complexity is triggered by events we can’t influence (regulations, globalization and the like), most is created by choice.
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What NSF’s Remediation Projects Are Saying About the Industry
| By NSF International
NSF Pharma Biotech Consulting is in a unique position in that our team is regularly and intimately involved in a range of GMP remediation projects across the world and across all dosage forms. Offering companies a different perspective on current industry thinking or for us to review and verify that the proposed CAPA will be effective across the full range of key attributes. These attributes include cost, timeframe, GMP compliance, sustainability, simplicity and ease of presentation to clients and regulators.
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NSF: What Works and What Doesn’t When Changing your Quality Culture and Improving GMP Behaviors
| By NSF International
Ever wondered why 70% of change initiatives fail, or why 95% of New Year’s resolutions are forgotten by February? The same reason traditional training methods have little impact on workplace behaviors, and why the “carrot and stick” (reward vs. punishment) approach to changing behaviors doesn’t work. In this article, we detail how to really change your quality culture and improve GMP behaviors.
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So How Is NSF Moving E.A.S.T.?
| By NSF International
How does an organization stand out from the crowd in the global marketplace, where businesses vie for attention and custom, and a multitude of choices exist in every transaction? Communication that seeks a change in an organization has to be Easy, Attractive, Social, Timely (E.A.S.T)
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Molnar-Institute: Benefits and Capabilities of DryLab®
| By Molnár-Institute
Anybody working in the realm of HPLC who wishes to economize the resources spent developing and running methods can benefit from the advantages offered by DryLab®.
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Elemental Impurity Analysis in Pharmaceuticals – The Road To Implementation of ICH Q3D
| By Butterworth Laboratories Ltd
Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients. Their guidance document, Q3D, reached step 4 in December 2014, meaning the final draft is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada.
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DryLab®4 - An Overview
| By Molnár-Institute
Exploring DryLab basics, method development strategy and DryLab benefits.
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DryLab®4 - Next Generation in HPLC Modeling
| By Molnár-Institute
DryLab® is the leading software solution for HPLC method development, optimization, troubleshooting, robustness testing and training. With less than 12 experimental runs, DryLab® is the only tool capable of delivering over one million precise chromatograms predictions and display the results in its user friendly interface. Its enhanced features will transform your chaotic method development into a comfortable and streamlined workflow, as well as increasing your productivity.
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Rapid UHPLC Method Development for Omeprazole Analysis in a Quality-by-Design Framework and Transfer to HPLC Using Chromatographic Modeling
| By Molnár-Institute
The aim of this study was to apply quality-by-design principles to build in a more scientific and risk-based multifactorial strategy in the development of an ultrahigh-pressure liquid chromatography (UHPLC) method for omeprazole and its related impurities.
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Enhanced Sampling and Calibration Procedures for the Analysis of Residual Oxygen in Nitrogen Purged Pharmaceutical Packaging by GC-TCD
| By Butterworth Laboratories Ltd
In recent times there has been a large increase in the type and number of products packaged using Modified Atmosphere Packaging (MAP) procedures. The majority of these processes concern the removal of oxygen from packaging systems in order to reduce oxidative degradation of the product and increase shelf life. Whilst most of the historical development of MAP took place within the food industry, over the last 20 years there has been a large growth in its application within the pharmaceutical sector.
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Transform Clinical Development Through Advances in Risk-Based Monitoring
| By Quintiles
This paper shares the challenges of clinical development along with an approach to trial execution gleaned from years of executing trials with risk-based monitoring (RBM) policies and processes.
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Integration of Molecular Biomarkers into Clinical Development
| By Quintiles
In the first of this two-part series, strategic drug developers Eric Groves, Jason Hill and Christopher Ung explain why biopharma cannot afford to ignore the growing surge of interest in biomarkers in oncology and discuss their critical role in the modern-day clinical development process.
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Personalizing Oncology with Genomics
| By Quintiles
Next-generation sequencing will transform oncology clinical trials and treatments for cancer.
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31-45 of 79 results