GxP Lifeline Newsletter
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January | 2019
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Quality Problems: Beyond Root Causes to 'Real Causes'
by David Manalan, Principal, INQC Consulting

 

If a quality problem arises, then something has changed. It may be obvious what the change is or we may have to investigate and discover it. Discovery of the change and preventing it from happening again is the definition of the basic root cause analysis and corrective action plan we’ve often followed, or observed.

 

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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.

 

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The Quiet Threat Inside ‘Internet of Things’ Devices
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Time Management: Walk the Talk, QA Professionals!
Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting

 

QA professionals are notorious for running out of time when daily tasks chew up their clocks. I know because it happens to me. As quality managers, we commend ourselves for being superb project managers, but for most of us, nothing could be further from the truth.

 

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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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