GxP Lifeline Newsletter
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November | 2017
MasterControl GxP Lifeline
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What is Pharmaceutical Quality by Design?
by Beth Pedersen

 

It seems that Quality by Test is well on its way to being a thing of the past, and for good reason. With only one out of every 10 drug products actually making it to market (1), it is no surprise that pharma companies are increasingly eager to adopt measures to ensure quality and manage risk.

 

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Don’t Let These Product Registration Problems Delay Your Time to Market
by Cindy Fazzi

 

The combination of a lengthy process and high cost of drug development is a hard pill to swallow for pharmaceutical companies. It should serve as the biggest motivation for them to find fundamental ways to accelerate their overall time to market.

 

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Quality 4.0 Impact and Strategy Handbook
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How a Pharma Company Automates CMO Audits
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FDA to Recognize Inspections from EU Drug Authorities
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SPECIAL BLOOD & TISSUE FEATURE
Nine Countries, Not US, Set to Eliminate Hepatitis C by 2030
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5 Guidelines for Writing a Useful Clinical Monitoring Report
by Brandy Chittester

 

A well-written monitoring report is an essential part of documenting clinical trial oversight. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight during an FDA inspection.

 

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HIPAA Compliance and Data Security Demand Equal Attention
by David Jensen

 

The Health Insurance Portability and Accountability Act (HIPAA) established by the U.S. Department of Health and Human Services (HHS) has been around since 1996. The components of HIPAA cast a wide net over regulations involving insurance coverage, medical records and tax rules.

 

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Risk Mitigation in Clinical Research: It Starts with Study Startup
by Criag Morgan

 

For clinical research, Study Startup (SSU) is the pivotal period that lays the groundwork for a successful study. By ensuring that the right sites are selected and target subjects are recruited in a timely and cost-effective manner, mission critical risks can be avoided that lead to runaway costs and delays. Up to now, risk management efforts have focused largely on regulatory compliance, manufacturing, and post-marketing drug safety.

 

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