GxP Lifeline Newsletter
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August | 2017
MasterControl GxP Lifeline
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6 Opportunities and Challenges Combo Product Makers Should Be Aware of in 2017
by Alex Butler, MasterControl

 

Thanks to constant leaps in scientific and technological innovation in recent years, we’re witnessing a steady (and very promising) trend toward combination products – those that merge two or more different types of regulated drugs, medical devices or biologics into one multi-faceted treatment.

 

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Keeping Up with the Top Pharma Industry Trends of 2017
by James Jardine, MasterControl Staff Writer

 

The pharmaceutical industry has realized steady worldwide revenue growth over the past 15 years[i], but there is an array of impending technological, regulatory, socioeconomic, and political changes on the horizon that may significantly impact pharma companies’ bottom lines.

 

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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. I thought I would share some of the messages and my takeaways from the two-day event.

 

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Scientists turned spinach leaves into beating human heart tissue
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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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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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