iSpeak Blog

November 28, 2017
One of the first education sessions at the recent 2017 ISPE Annual Meeting & Expo in San Diego, California, was “Aligning System Validation and Data Lifecycles,” held Sunday afternoon, 29 October, even before the opening keynote was delivered. Leader...
November 27, 2017
This article was originally published in the September-October 2017 issue of Pharmaceutical Engineering ® magazine . Missed part one and two? Catch up now – The Engineer's Role in the Biopharmaceutical Supply Chain – Part 1 and The Engineer's Role in...
November 22, 2017
The European Commission has chosen Amsterdam as the new host of the European Medicines Agency (EMA) headquarters. The city was awarded the coveted prize after it won a coin toss with Milan, which received the same number of votes after three rounds o...
November 20, 2017
As global regulators sharpen their focus on data integrity, issues have emerged around practices observed in operations that generate data used to make drug product decisions. One such practice is “testing into compliance”-- repeatedly analyzing a sa...
November 09, 2017
This article was originally published in the September-October 2017 issue of Pharmaceutical Engineering® magazine . Missed part one? Catch up now – The Engineer's Role in the Biopharmaceutical Supply Chain – Part 1 . Get part three delivered straight...
November 08, 2017
This article was originally published in the September-October 2017 issue of Pharmaceutical Engineering® magazine . Get part two of this series delivered straight to your inbox by subscribing to iSpeak . As the industry evolves in its quest to increa...
November 07, 2017
It’s time for another edition of Reading Roundup featuring the top blog posts of October 2017. Start off your week by catching up on what the pharmaceutical industry was reading in October. The New Normal - Pharmaceutical Engineering Magazine Editori...
November 02, 2017
It may have been Halloween, and some participants may have been in costume, but the membership breakfast Tuesday morning for Day 3 of the 2017 ISPE Annual Meeting & Expo was all about receiving treats rather than playing tricks. The hallmark of each...
November 01, 2017
Disclaimer: This is an abridged, unofficial summary of FDA regulators’ responses during a panel discussion at a conference that has not been vetted by the agency. The responses below are an informal and brief synopsis of the panel’s views, and do not...
October 31, 2017
DAY 2 WRAP UP! Incoming Board of Directors Chair Timothy Howard, Vice President, Commissioning Agents, Inc., opened day two of the 2017 ISPE Annual Meeting & Expo by thanking delegates for their attendance. “Whether this is your first annual meeting...