iSpeak Blog
Excellence is everywhere, and it must be illuminated. For the fourth consecutive year, the annual ISPE Italy Affiliate Award for women in the pharmaceutical sector will be organized by the local group of ISPE Women in Pharma® (WIP). This important initiative was created to celebrate the commitment, perseverance, professionalism and competence of the women who work in this sector, qualities...
iSpeak Blog
A key challenge in life sciences is the detrimental effect of unplanned downtime and lost batches due to unanticipated equipment failure. Traditional maintenance programs are calendar or condition-based and can range from being overly conservative to reactive, leaving money on the table (over-maintenance - “just in case”), or jeopardizing productivity altogether. As described in the ISPE Good...
iSpeak Blog
As one of the founders of Cheme Engineering, Nik Krpan was instrumental in the start-up of the company. He became president of the company in 2012. Nik says that leading the company through continued growth has been an exciting aspect of his career. “We started with five people and now we have more than sixty. It’s been really rewarding to be part of a creating an environment where people can...
iSpeak Blog
By the ISPE Regulatory Team ISPE’s regulatory volunteer groups are charged with bringing visibility and solutions to major challenges faced by the industry with regard to regulatory/quality matters, and facilitating the flow of information between ISPE members and global Health Authorities. Support for that mission was on display at the 2022 ISPE Annual Meeting and...
iSpeak Blog
As we are all aware, the COVID-19 pandemic has had a unique, world-wide effect on the pharmaceutical industry as well as health authorities. At the height of the pandemic, and continuing as it appears to wane, health authorities have not been able not carry out normal, in-person inspections of pharmaceutical manufacturing sites. However, in the ”Age of Covid,” using the Internet and associated...
iSpeak Blog
On 17 August 2022, four international regulators discussed how the Covid-19 pandemic had taught regulators to look for alternative ways of doing GMP inspections and also to rely more on each other to make determinations on the GMP status of manufacturers of medicines.
iSpeak Blog
A look through the lens of GAMP 5® Second Edition IT Infrastructure is a broad term that encompasses both the platforms upon which business applications run, as well as the services that keep these platforms and applications running. Figure 1 below shows this landscape.
iSpeak Blog
The 2022 ISPE International Emerging Leader Hackathon officially started on Saturday 29 October 2022 at 0800 EST, but the connections started happening the night before during the Hackathon Reception at Wreckers Bar and Grill in the Gaylord Palms Resort, Orlando, FL USA.
iSpeak Blog
The industry is in the process of a transformation that was sped up by the pandemic, which enhanced innovation and collaboration. Applying what has been learned over the last three years to update pharmaceutical companies’ approaches to development and implementation is key as the industry crafts its strategies in an increasingly digital and global environment. The keynote presentations on 1...
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