GxP Lifeline Newsletter
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April | 2018
MasterControl GxP Lifeline
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Top 5 Pharmaceutical Trends to Keep on the Radar in 2018
by Mike Rigert, Staff Writer, MasterControl

 

The pharmaceutical industry in 2018 continues to be buffeted from within and without as transformational changes influence manufacturers in a variety of ways. From new technologies, to new pressures, to new methods of drug discovery, the sector is a beehive of activity for which manufacturers must plan for, pivot and re-prioritize.

 

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Strategic Design of the Supply Chain: Too Little, Too Late for Pharma?
by Hedley Rees, Managing Consultant, PharmaFlow

 

Across the globe, the pharma supply chain has been under attack from governments, regulators and other key stakeholders for many a year. Issues such as high costs, slow response times, poor quality levels, economic adulteration of materials, shortages, consent decrees, counterfeiting, product diversion and theft consistently rear their ugly heads.

 

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12 Free Resources to Boost Your Pharmaceutical FDA Readiness
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Advancing Beyond CAPA Compliance, Using Innovation for Improvement and Growth- Part 1
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What’s New for Biologics
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UK's MHRA Issues Final Guidance on GxP Data Integrity
by Mark Schwartz, Director, Hyman, Phelps & McNamara

 

It has been two years since the U.S. Food and Drug Administration (FDA) published its draft guidance on Data Integrity and Compliance with cGMP, with much fanfare and some legitimate criticism from stakeholders, particularly criticism regarding some overarching assertions that the agency made that are difficult to justify on the basis of the regulatory texts in question.

 

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GDPR Deadline Approaches: What is Expected for Compliance?
by Beth Harper, President, Clinical Performance Partners

 

First the bad news. As long as health care-related data remains a valuable commodity, security breaches and data theft will persist. The good news is global regulatory agencies are ramping up their cybersecurity measures in an effort to restore relevance to the “protection” component of protected health information (PHI).

 

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Top 5 Up-and-Coming Trends for Nutraceuticals in 2018
by Sarah Beale, Staff Writer, MasterControl

 

The popularity of the nutraceuticals industry is soaring, with many people now starting the day by popping a multivitamin, eating yogurt for a good dose of probiotics, or mixing a couple of drops of an herbal extract into a smoothie.

 

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