GxP Lifeline Newsletter
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September | 2018
MasterControl GxP Lifeline
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Beyond the Mandates: The Business Value of Mass Serialization and Supply Process Visibility, Part 2
by Carla Frances Reed, President, New Creed

 

In common with other industries (electronics and automotive, in particular), the pharmaceutical industry now includes a multitude of players across an increasingly outsourced network of transformation and distribution partners.

 

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Ugly Babies, Silent Enemies and Other Short Stories from a Continuous Improvement Conference
by Chet Marchwinski, Communications Director, Lean Enterprise Institute

 

Continuous improvement professionals, managers, and executives from the U.S. and Canada presented at the recent Canadian Lean Conference in June 2018, which drew about 1,000 business leaders to Winnipeg. Presenters shared lessons and results from lean transformation efforts as well as some personal journeys.

 

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FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 2
by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant

 

This is the second part of a two-part series about a presentation by U.S. Food and Drug Administration (FDA) experts Dell Moller and Nicholas Paulin at the FDA/Xavier PharmaLink conference at Xavier University in Cincinnati, Ohio, in March 2018, about the agency's top 10 drug GMP inspection citations for FY 2017.

 

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Artificial Intelligence: Is It on the Cusp of Revolutionizing Pharmaceuticals?
by Mike Rigert, Staff Writer, MasterControl

 

One of the trends examined in the white paper is the advent of artificial intelligence (AI) and how that nascent technology is not only making substantial inroads in the life sciences generally, but in pharmaceutical manufacturing more specifically.

 

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