The 2020 ISPE Annual Meeting & Expo will be ISPE’s first completely virtual Annual Meeting. As always, there will be great learning and networking opportunities—in fact, the digital format offers greater flexibility for attendees.
Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year Awards (FOYA) program. This year, we added a new category, Social Impact, to recognize companies that developed new standards and practices to prevent drug shortages and increase patients’ access to medicine, designed new tools or techniques that reduced the cost of drug...
Vaccine development is an intricate undertaking, which may involve numerous challenges from the initial process of identifying an antigen to the final steps of delivering and administering the licensed product. The COVID-19 pandemic has put a spotlight on the science of vaccine development. As the world awaits a vaccine for the coronavirus, manufacturers face unprecedented pressure to respond...
This article updates a 2006 Pharmaceutical Engineering® Online Exclusive article titled “Avian Flu—Is My Company Prepared?” by Wendy Haines and Martin Rock.1
When faced with large-scale disruptive events such as the COVID-19 pandemic, the emergency and business continuity plans of drug manufacturers and event-specific actions of health authorities may not always be sufficient to prevent shortages of critical medical products. However, early, transparent engagement with health authorities is a powerful opportunity for drug manufacturers to...
The 2019 ISPE Annual Meeting & Expo plenary featured a global regulatory town hall addressing a wide range of information about trends in regulations and other developments in the pharmaceutical industry....
The first ISPE Global Hackathon was held at the 2019 ISPE Annual Meeting & Expo with six teams and 36 participants, including 19 undergraduate students, 11 graduate students, and 6 Young Professionals...
This special section looks at what’s coming up at the 2019 ISPE Annual Meeting. It also features the voices of first-year Travel Grant recipients who attended last year’s Annual Meeting courtesy of the
The 2019 ISPE Annual Meeting & Expo will be held 27–30 October in Las Vegas, Nevada. The theme is “Modernize. Globalize. Transform.” Michael L. Rutherford, Program Committee Chair and Board Ambassador for...
The ISPE Young Professionals Hackathon, which has become an annual event run in conjunction with the ISPE Europe Annual Conference, brings together some of the brightest, most inquisitive young engineers...
More than 800 attendees met in Dublin, Ireland, on 1–4 April for the 2019 ISPE Europe Annual Conference—a new record attendance for this conference! Participants at ISPE’s sixth Europe conference learned about...
As members of the Architecture Team of the ISPE Pharma 4.0™ Plug & Produce Initiative, we would like to share the principles we have developed with the broader life sciences community. Our aim is to foster further exchange and...
ISPE’s initiative to transform industry-generic 4.0 models for pharma operations will help the industry benefit from digitalization.
The ISPE Advancing Pharmaceutical Quality (APQ) team is developing a framework by which a company can assess its maturity in relation to quality culture, operational excellence, and ICH Q10 elements, using the CAPA system as the focus of the pilot.
ISPE Quality Culture Team members share key concepts represented in the Six Dimensions of Cultural Excellence framework.
The basic framework of the program is to "assess and aspire" quality maturity.
This year's Europe Annual Meeting in Rome featured YP track leads, YP keynote speakers Caroline Rocks and Robert Landertingera.
In March 2018, more than 640 attendees met in Rome for the 2018 Europe Annual Conference.
Johnson & Johnson Supply Chain Experience
Fifteen years ago, corporations embarked on a journey toward SOX compliance; along the way they have learned a tremendous amount about data integrity as it relates to financial systems. Those lessons learned are directly applicable to many of the data-integrity challenges facing the pharmaceutical industry today.
Individuals with privileged access have the technical means to bypass the user interface to access and modify data, often times without traceability.
As the industry evolves in its quest to increase quality, productivity, efficiency, and safety, engineers must be equipped with skills that enable them to meet new and challenging demands. This first in a two-part series focused on biopharmaceutical manufacturing explores a few of the exciting roles engineers play to drive continuous improvement. Part 2, slated for Pharmaceutical Engineering's...
This article was developed by members of the ISPE Biotechnology Community of Practice. The views and opinions are those of the authors and do not necessarily reflect the official policy or position of Hargrove Life Sciences, M+W, Novartis, Sandoz, Takeda, or any of their officers.
This paper discusses the findings and outcome of the ISPE Continuous Manufacturing Conference held 20–21 April 2016 in Baltimore, Maryland. While the ideas captured below reflect presentations and discussions both during the main conference and in breakout sessions, they are not necessarily the views of the authors or their organizations.
ISPE knows that the future of the pharmaceutical industry lies with its youth—and to prove it, we’ve contacted five former contestants to see how the competition affected their careers.
ISPE knows that the future of the pharmaceutical industry lies with its youth—and to prove it, we've contacted five former contestants to see how the competition affected their careers.
