iSpeak Blog

October 06, 2017
FDA wants us to instill a strong quality culture in our operations. To track our progress toward that strong quality culture we have been asked to measure quality parameters. Those metrics are presumed to reflect the underlying quality culture of an...
October 05, 2017
Many spend their summer relaxing, perhaps traveling, but generally trying to “put their feet up.” Others change the course of health care as we know and practice it. Gilead’s purchase of Kite Pharma, one of the companies developing chimeric antigen r...
October 03, 2017
It’s time for another edition of Reading Roundup featuring the top blog posts of September 2017. Start off your week by catching up on what the pharmaceutical industry was reading in September. 5 Key Steps in the Calibration Optimization Journey John...
October 02, 2017
This year’s ISPE Annual Meeting & Expo will be full of great, thought-provoking content for the Investigational Products Community of Practice. The theme “ Driving Innovation to Advance Patient Therapie s” aligns with the Investigational Products tra...
September 28, 2017
This article was originally published in the September–October 2017 issue of Pharmaceutical Engineering® magazine . Missed part one? Catch up now – Biopharma's Portfolio Drives New Technology – Part 1 . While regulators seek assurance of technically...
September 27, 2017
Participants gathered for the Women in Pharma breakfast on day 2 of the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference, held June 5–7, 2017. Women in Pharma Chair, Fran Zipp, President and CEO, Lachman Consultants and ISPE Board member, welcomed...
September 26, 2017
This article was originally published in the September–October 2017 issue of Pharmaceutical Engineering® magazine . The portfolio sold by today’s global biopharmaceutical industry is fundamentally different than it was even a decade ago. This shift i...
September 22, 2017
Involved in the biotechnology industry now or want to be in the future? You should register for the ISPE 2017 Annual Meeting & Expo . This year’s event takes place in sunny San Diego, California from 29 October through 1 November. Sessions will addre...
September 20, 2017
This article was originally published in the July – August 2017 issue of Pharmaceutical Engineering® magazine . Missed part one and two? Catch up now – Performance and Validation of Ozone Generation for Pharmaceutical Water Systems – Part 1 and Part...
September 19, 2017
Wided Najahi-Missaoui Granted First Women in Pharma Scholarship Wided Najahi Missaoui, MS PharmD The Women in Pharma (WIP) Networking Community launched its first education series at the ISPE 2016 Annual Meeting & Expo. Thank you Fran Zipp and Charlo...