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iSpeak Blog
There are two different sides of confidence which I would like to discuss here: the idea of confidence in the workplace and confidence in oneself.
iSpeak Blog
The issue of data integrity may appear archaic in a highly connected, digital world. Yet many within the pharmaceutical industry it continues – be it intentional or not – to fall foul of regulators tasked with auditing businesses’ practices. Peter Cusworth at Yokogawa examines an age-old problem,...
iSpeak Blog
The wait is over… The 2021 ISPE Annual Meeting & Expo is back and will be held in Boston, Massachusetts, at the Hynes Convention Center and Sheraton hotel from 31 October–3 November. This year’s conference theme, ‘Agility. Collaboration. Innovation.’, truly represents how our industry has responded...
iSpeak Blog
I am excited to share with you that the first “Face to Face” ISPE Conference since the beginning of COVID-19 is now scheduled to take place in Rockville, Maryland, USA, on 28–29 September. The 2021 ISPE Facilities of the Future Conference will be an in-person, live event full of topics of great...
iSpeak Blog
Thomas Hartman, ISPE’s President & CEO and active ISPE Member for over 20 years, speaks with us on his favorite ISPE memories, his real-world examples on the benefits of ISPE, and why volunteering is so important. Join us as we get to know Thomas a little more.
iSpeak Blog
Dr. Randy Perez retired from the position of Director of Information Governance and Management for Novartis Pharmaceuticals in 2015. During his 32-year tenure at Novartis his responsibilities included a wide range of IT Compliance issues, such as GxP, Sarbanes-Oaxley, and data privacy. He served on...
iSpeak Blog
ISPE continues to work with a group of industry associations to assist the European Union (EU) and the European Medicines Agency (EMA) with implementation of revision of Annex 1, Manufacture of Sterile Products. Annex 1 is a key document in "The rules governing medicinal products in the European...
iSpeak Blog
As a young Science graduate, I couldn’t think of anything worse than being stuck at the same desk, day in / day out, in a stuffy office, doing the same thing day after day, just to earn a living. There had to be more to life, right? I wanted to travel the world, see new places, not be defined by...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from April 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
iSpeak Blog
While Pharmaceutical development and manufacturing have focused for years on robust quality management systems (QMS), the application of quality risk management (QRM) applying digital tools and advances are critical to future success. Coupling controls, artificial intelligence, and associated...
iSpeak Blog
ISPE’s quality management maturity program, Advancing Pharmaceutical Quality (APQ) has progressed significantly. The first Good Practice Guide in a series, Corrective Action, Preventive Action (CAPA) was published in December 2020. To assist practitioners, a complimentary webinar, Advancing...