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...

iSpeak Blog

The 2022 ISPE Annual Meeting & Expo opened with three keynote addresses exploring quality from a key FDA leader’s point of view, a major pharmaceutical company’s ongoing journey of transformation into an organization that is prepared to adapt to the changing world, and a unique patient perspective with a patient presenter who is also a member of the pharmaceutical community.

iSpeak Blog

Driving the transition to the digital world through the quality and validation lenses

We are The Culture Club, a self-formed cross-CoP group of individuals who came together to discuss the quality/validation challenges encountered as we transition into the digital world and identify ways to influence cultural changes needed within our industry to better enable innovation. This blog...

iSpeak Blog

ISPE’s Transportable/Point of Care (PoC) Manufacturing Technology team, a working group under the Product Quality Lifecycle Implementation (PQLI)® committee, is presenting a session entitled Transportable, Small Footprint Biopharmaceutical Manufacturing Facilities: A Regulatory Perspective at the 2022 ISPE Annual Meeting & Expo on Monday, 31 October at 1100–1230 as part of the...

iSpeak Blog

Helping people, projects and companies succeed are the aspects Dharti Pancholi has enjoyed most about her career in the pharmaceutical industry. “I really like empowering people whether it is my team or my clients. It is great to bring together people who have a diverse set of experiences, skills, or perspectives, who might not normally work together, and collectively develop something, grow a...

iSpeak Blog

Global demand for plasma-derived therapies (PDTs) continues to swell—the compacting result of an aging population, clinical successes, and recent applications for both widespread diseases and multiple rare conditions. Serving these needs has been a significant challenge over the last two and a half years, with a decline in plasma donations due to the COVID-19 pandemic. The donation shortage...

iSpeak Blog

Honorable Mention recognizes projects that did not win a specific category but were clearly successful projects that overcame significant challenges in planning, execution, and delivery.

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