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CONSULTING SERVICES FOR LIFE SCIENCE ORGANIZATIONS

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THE NEED


The philosophy of Quality is constantly evolving. Before the 1950s, Quality was generally defined as the absence of defects in a finished product as determined by final inspection. In the second part of the 20th century, guided by revolutionary thinkers like Joseph Juran and W. Edwards Deming, industry adopted a much more holistic view of Quality. Success in the modern economy requires a systematic adoption of Quality policies throughout the product or service life cycle, from initial design through marketing. FDA’s approach to modern Quality began with the Quality System Regulation, 21 CFR 820, which codified the Quality by Design approach for medical devices.  More recently, FDA issued guidances on application of the Quality Systems approach to pharmaceutical development.



OUR APPROACH


We will work with you to develop a Quality strategy.


As appropriate, we will bring in theories, methods, and other resources to help your organization to optimize its performance. At the same time, we will always work with the understanding that the most important and most relevant information is your company’s knowledge of its product and its processes. We will help you to develop and deepen your understanding.



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