Knowledge

Information on pharmaceutical and biopharmaceutical hot topics, best practices and more.

iSpeak Blog
Overall Equipment Effectiveness (OEE) is a key metric for Packaging Operations. When used well, it can help determine the effect of continuous improvement and when it is the right time to add new capacity or replace existing equipment. It is not...
iSpeak Blog
Why is water so crucial to the pharmaceutical industry? Water is required for production of all pharmaceutical products and can be the most expensive ingredient in some applications due to the large volumes required for production and cleaning. Water...
iSpeak Blog
It’s time for another edition of Reading Roundup featuring the top blog posts of May 2017. Start off your week by catching up on what the pharmaceutical industry was reading in May. Celebrate 8 Companies Who Are Advancing Pharmaceutical...
iSpeak Blog
New Format for Stronger Interaction Fifth Annual ISPE/FDA/PQRI Quality Manufacturing Conference John Bournas, ISPE CEO and President, welcomed attendees to the fifth annual ISPE/FDA/PQRI Quality Manufacturing Conference, themed “Align Your Company...
iSpeak Blog
It’s time for another edition of the Reading Roundup featuring the top blog posts from March 2017. Start off your weekend by kicking back and catching up on what the pharmaceutical industry was reading in March. Data Quality and Data Integrity: What is...
iSpeak Blog
Shaping Excellence: How Leader Actions and Behaviors Influence Quality Culture Part 2 Quarterly Report on Quality Culture This article was published in the November/December 2016 edition of Pharmaceutical Engineering® magazine in the Quarterly Report...
iSpeak Blog
The Third Annual ISPE-FDA CGMP Conference, held in Baltimore, Maryland 2-6 June  2014, opened on Monday, 6 June  with welcoming greetings offered by ISPE President and CEO Nancy Berg who introduced co-conference organizers Joe Famulare, vice president,...
iSpeak Blog
Design Considerations for Water for Injection (WFI) Distillation Systems for Improving Quality, Project Performance, and Equipment Life Cycle Cost Reduction was featured in the September/October 2015 issue of Pharmaceutical Engineering® magazine. This...
Technical
This three-part paper focuses on the final results from the EU and China Patient Perceptions of Investigational Medicinal Products surveys and compares some of these results with the original "ISPE Project Concerning Patient Experience with Clinical Trial Materials" published in 2013.