It’s time for another edition of the Reading Roundup featuring the top blog posts from May 2016.  Grab your favorite cup of coffee, kick back and catch-up on what the pharmaceutical industry was reading in May.

FDA Data Integrity Draft Guidance – Opportunity for Pharma Industry

What information does the FDA Data Integrity Draft Guidance provide?  What can your company due to create a road map for compliance?  Get the inside scoop on how data integrity is impacting the pharmaceutical industry and the resources available to assist you and your company moving forward.


Are You Throwing Out GxP Records Electronically?

A number of firms have been cited for GxP records in their disposal bins.  It is easy to read these observations and conclude they do not apply to your firm – but are you sure?  You might have instructed personnel that they must never place a regulated document in the paper bin – but have you also instructed them to do the same with electronic disposal bins – the Recycle Bin in workstation computers?  Get the inside scoop on how you should be handling electronic disposal bins.


Design Considerations for WFI Distillation Systems Part 3

This four-part series presents and discusses a number of key requirements and design, quality, and engineering considerations that have high importance in end-user usability, cost control and end-product quality that help manage risks in Water for Injection production and processes.  Part three reviews:

  • Should you expand your current facility or build a new one?
  • Typical Utility Connections for WFI distillation systems
  • Efficacy of High Temperature and Particle Separation of WFI Process
  • F0 of WFI Process

Brexit: Impact on Pharmaceutical Industry

On 23rd June 2016, United Kingdom (UK) citizens will vote to stay in or leave the European Union (EU).  Current opinion polls suggest the public is fairly evenly split on the matter.  Learn about how this vote could impact the pharmaceutical industry.


How Should Clinical Supply Chain Performance Be Measured?

With this discussion paper/survey, we are encouraging the community of Clinical Supply Chain professionals to provide input on the importance and prioritization of the most relevant metrics, potential challenges, and solutions to overcome them, along with how each metric should best be captured for purposes of standardization.  Learn about this initiative and participate in the survey which closes on 15 June 2016.

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