iSpeak Blog

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...
October 30, 2017
Greetings from San Diego! “America’s Finest City” welcomed some 1,600 attendees, including 255 delegates from 34 countries from outside the United States, to the 2017 ISPE Annual Meeting & Expo at the San Diego Marriott Marquis & Marina on 29 October...
October 27, 2017
Know Before You Go! Conference Essentials Explore the Conference Program Travel Tips Hotel Dining Options Registration and Information Hours Saturday, 28 October | 1300–1800 Sunday, 29 October | 0700–1800 Monday, 30 October | 0700–1800 Tuesday, 31 Oc...
October 26, 2017
San Diego, also known as the “City in Motion”, is the second largest city in California and the 8 th largest city in the United States. The city hosts over 32 million visitors annually for business and/or leisure purposes. As an attendee of the 2017...