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ISPE's Role in Advancing Pharmaceutical Manufacturing
2025-05-20T16:41:47

To launch the first episode of the podcast, Mike Martin, President & CEO of ISPE, joins to discuss the current pharma landscape and ISPE’s role in advancing pharmaceutical manufacturing, engineering, science, and regulations.

GAMP CoP "GAMP and ISA 95"

11 June 2025 - 11 June 2025
GAMP CoP "GAMP and ISA 95" Chris Monchinski, chair of the ISA-95 Standard Committee, will present on the important relationship between the ISA-95 Standard on integration between the business systems (ERP) and the control systems and the strong...
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iSpeak Blog
When Analytics Meet Quality
In today’s data-driven world, the quality management paradigm in the biotech industry has transcended traditional methodologies, embracing advanced analytics and emerging technologies to redefine efficiency, precision, and speed to market. The adoption of machine learning, predictive analytics, and big data has revolutionized quality management, enabling companies to address complex challenges...

AstraZeneca Rockville Manufacturing Center - Facility Tour

6 June 2025 - 6 June 2025
Join the ISPE CBA Emerging Leaders committee for an exclusive tour of the brand-new AstraZeneca new Rockville Manufacturing Center (RMC). The new CAR-T therapy Manufacturing Facility is nearing construction completion. The tour will highlight some of...

Programs: Beyond EtO: Alternative Sterilization Processes for RTF Containers and Medical Devices

18 June 2025 - 18 June 2025
Ethylene oxide (EtO) gas sterilization is used across the pharma industry for a variety of products, including but not limited to medical devices. In light of FDA news release of January 2024, which encouraged end users to seek alternative...
A Regulatory Surveillance and Advocacy Framework
iSpeak Blog
A Regulatory Surveillance and Advocacy Framework

At the 2024 ISPE Annual Meeting & Expo, a session titled “Regulatory Surveillance and Advocacy” was presented by Christine Moore, PhD, Executive Director, Quality Systems and Compliance at Organon LLC. Moore spoke about the definition of regulatory surveillance of policy and standards, and going beyond surveillance into regulatory intelligence, specifically related to inspections and...

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iSpeak Blog
Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
Digital transformation isn’t a future concept in the biopharmaceutical industry—it is already impacting manufacturing and quality control processes. Recent advancements and best practices will be showcased at the upcoming 2025 ISPE Biotechnology Conference, where the track “Implementing Digital Initiatives in the Biopharmaceutical Industry: Where Are We on the Road Map?” dives deep into the...
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