iSpeak Blog

January 26, 2018
And the 2017 Article of the Year Winner Is ... Congratulations to Prof. Christoph Herwig, PhD, Christian Wölbeling, and Thomas Zimmer, PhD—authors of the 2017 Article of the Year. Their article "A Holistic Approach to Production Control: From Industr...
January 24, 2018
It’s time for another edition of Reading Roundup featuring the top blog posts of December 2017. Start off your week by catching up on what the pharmaceutical industry was reading in December. FDA, Data Integrity, and the Dreaded Twenty-Five Words “Yo...
January 23, 2018
ISPE’S Member of the Year Award was established in honor of Max Seales Yonker, an active member, leader, and contributor to ISPE and to the industry. When ISPE lost this bright spirit to cancer in 2005, we honored her memory with an award that recogn...
January 18, 2018
This article was originally published in the January-February 2018 issue of Pharmaceutical Engineering ® magazine . Catch up on this series by reading: How Robust Is Your Process Capability Program? Part 2 How Robust Is Your Process Capability Progra...
January 16, 2018
Christine M. V. Moore, PhD, Global Head and Executive Director, Merck & Co., led “Changes in the Regulatory Landscape,” an education session held 31 October during the 2017 ISPE Annual Meeting & Expo . The first speaker, Ellen F. Morrison, Assistant...
January 12, 2018
As co-chairs of the Barrier Track program at the 2018 ISPE Aseptic Conference , Michael Faia and I built this year’s program around real-world case studies from an all-star line-up of leading sterile manufacturers including: Biogen Bristol Meyers Squ...
January 11, 2018
This article was originally published in the September–October 2017 issue of Pharmaceutical Engineering ® magazine . Catch up now if you missed Part 1 , Part 2 , or Part 3 . To shed light on the role of engineers in biopharmaceutical manufacturing, t...
January 04, 2018
The annual ISPE Aseptic Conference continues to provide cutting-edge education in aseptic technology. The 2018 ISPE Aseptic Conference , 6 -7 March in Reston, VA, marks 27 years of providing information to ensure safe and reliable product supply whil...
December 13, 2017
By: Valérie Vermylen, Jean-Etienne Fortier, Eric Rulier, Alain Bernard, Carl Jone, and Justin Neway Understanding how variability in biopharmaceutical product quality, manufacturing, and controls (CMC) affects both safety and efficacy is a major goal...
November 30, 2017
Joe Robinson, QCxP, CPIP Director of Business Development Midwest Commissioning Agents, Inc. (CAI) Where did you go to college/university and what was your major? (and if it wasn’t pharmaceutical engineering, how did you end up in this field?) I did...