iSpeak Blog

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
Name: Joe Robinson, QCxP, CPIP Title: Director of Business Development Midwest Company Name: 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 en...
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...