iSpeak Blog

Reading Roundup: Top Blog Posts from March 2016

Laptop with Morning Coffee

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

Data Integrity and Your Interfaces

All interfaces have the potential to present data integrity issues, due to their nature.  Receive suggestions on how to mitigate the data integrity issues for a net result of correct data being available for business personal to make decisions.


Considerations for a Corporate Data Integrity Program

Data integrity has become one of the hottest regulatory and compliance topics impacting the pharmaceutical industry in years.  To help understand the critical success factors for a corporate data integrity program, the ISPE GAMP® COP released a Concept Paper entitled “Considerations for a Corporate Data Integrity Program”.  Learn more about the data integrity concept paper and download it today!


Introduction to EU Clinical Trial Regulation No. 536/2014

ISPE’s Investigational Products Community of Practice (IP COP) is taking a deep dive into understanding all the ramifications of EU Clinical Trial Regulation No. 536/2014 and the impact it will have on running clinical trials.  Read the first installment of the EU Clinical Trail Regulation series.


Washers and Sterilizers: Design, Manufacturing & Qualification Documentation

The final part of the three part series on Non-GMP or GMP Washers and Sterilizers:  How to Choose.  Part three covers the design, manufacturing and qualification documentation needed on GMP washers and sterilizers.  The series also wraps up with helping you decide which option is best for your facility.


Wet Granulation Knowledge Brief

Get all of the details on granulation from this in-depth knowledge brief including:

  • Why Granulate Pharmaceuticals
  • Types of Web Granulation
  • Advantages and Limitations
  • Design Considerations