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November | 2018
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Quality Assurance and Quality Control: What's the Difference When It Comes to Managing Quality?
by Kimberlee A. Washburn, Regulatory Affairs Author

 

For most companies in the life science and manufacturing sectors, the function of quality assurance occupies a space independent of that of actual manufacturing and operations. The same could be said for quality control. But what is the difference between these two essential components of quality manufacturing and why do they matter?

 

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Building an Audit-Ready QMS
by Joy McElroy, Consultant and Business Development Director, Maynard Consulting Company

 

The definition of quality of a pharmaceutical product means the product is fit for its intended use, is free from defects, and meets or exceeds customer expectations. The general public assumes manufactured pharmaceutical products are safe, efficacious, and have the correct identity.

 

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Risk Management and the Human Species
by Rai Chowdhary, CEO and Founder, The KPI System

 

We consider ourselves a smart species; after all, we make smart decisions, we have smart phones, smart cars, smart this and smart that. How smart are we really? A full discussion on that will be a long-drawn dialog, so I will reserve it for another time.

 

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Expert Tips on Enhancing CAPA Through Innovation
by James Jardine, Staff Writer, MasterControl

 

The value of an innovation in corrective and preventive action (CAPA) management is completely dependent on its practical application as a solution. But the quality sphere has no use for innovation purely for innovation’s sake.

 

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