GxP Lifeline Newsletter
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August | 2017

What Is a Quality Control System and How Can an EQMS Improve On It?
by David R. Butcher, Staff Writer, MasterControl

 

For organizations doing business in regulatory environments, successful quality assurance and quality control are crucial aspects of quality management in FDA- and ISO-regulated environments. Often, “quality control” and “quality assurance” are used interchangeably, referring to the activities conducted to ensure the quality of a product, service or process.

 

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Thoughts from 2017 PDA Quality Metrics and Quality Culture Conference
by Stephanie Gaulding, CQA, CPGP, DPS Engineering

 

I had the pleasure spending two days networking and discussing quality metrics and quality culture with industry and FDA leadership at PDA's 2017 Quality Metrics and Quality Culture Conference last February. This year's conference included some of the most candid and honest dialog on these topics that I've seen between industry and FDA to data.

 

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5 Tips for Getting Executive Backing for a New or Expanded EQMS
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Why Supply Chain Agility Is Essential For Food Manufacturing
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Good Communication Skills are Key for Inspection Readiness
by UL

 

When an FDA inspector comes to your door, it is usually a time of stress and uncertainty. You need to handle logistical elements like where the inspectors are going to be placed, how you will gather the requested data and forms, how prepared the facility is and with whom will the inspectors be interacting.

 

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Avoiding CAPA Pitfalls: 10 Tips from a Food Industry Quality Expert
by James Jardine, MasterControl Staff Writer

 

At a recent ASQ Salt Lake Section symposium held at the headquarters of quality management software solutions provider MasterControl in Salt Lake City, food safety expert Jack Hamilton of EAGLE Certification Group shared some best practices for avoiding problems in managing corrective and preventive action (CAPA) systems.

 

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