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NSF asks a Production Director for their views on moving forward with KPIs
| By NSF International
KPIs and the Production Director: Select Fewer, More Significant KPIs and Set Goals for Your Metrics
Contract Research & Services > Contract Services > White Papers
NSF determines what KPIs mean for Employees
| By NSF International
KPIs and Employees: Involve Us Upfront and Let Us Help Define Relevant Measures
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NSF asks ex-MHRA Inspector about the Importance of KPIs and gets Interesting Results
| By NSF International
KPIs and the Regulator: I’m Looking for Quality Metrics, Management Review and Continual Improvement.
Contract Research & Services > Contract Services > White Papers
Tech Talk: CHANGING GMP BEHAVIORS with NSF
| By NSF International
Most people are content sticking with what they know and their tried and tested habits. It’s easy. To get people to think and act differently (a painful process for most), you have to provide them with the motivation.
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NSF: KPIs and the Head of Corporate Quality: KPIs Are Essential for a Successful Product Release
| By NSF International
What are your views on KPIs? Essential or a necessary evil? “They are absolutely essential, providing they are good! I remember during a regulatory inspection I was asked every QP’s most feared question: How do you know everything is in control before you release product?
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NSF: Learn from a Fabulously Successful GMP Remediation Program
| By NSF International
This White Paper describes a remediation program that appeared at first to be impossibly daunting, expensive and unattainable. The company had received a range of critical and major GMP deficiencies from the UK regulatory body, MHRA, and was facing a referral to MHRA’s Inspection Action Group. Manufacturing had to be suspended pending a risk assessment of the non-compliances; evaluating the effect of the non-compliances in terms of risks of misbranding and adulteration of the products. Shifts were cancelled, the supply chain was suspended and an urgent remediation program begun.
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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)
Contract Research & Services > Contract Services > White Papers
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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