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Global News

22 November, 2024
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iSpeak Blog

FDA CDER Associate Director Speaks About Regulatory Reliance and Agility

Theresa Mullin, PhD, Associate Director for Strategic Initiatives at the US Food and Drug Administration’s (US FDA) Center for Drug Evaluation and Research (CDER), opened the

22 November, 2024
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iSpeak Blog

A Message from the 2025 ISPE Aseptic Conference Chair

The 2025 ISPE Aseptic Conference, taking place 17 – 18 March 2025 in Washington, D.C., USA, has always been one of the more future-focused technical conferences within ISPE

20 November, 2024
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iSpeak Blog

Unlock the Future of Pharmaceutical Manufacturing: Learn from Industry Leaders at the 2024 ISPE Pharma 4.0™ and Annex 1 Conference

In an era where technological advancements are reshaping every industry, the pharmaceutical sector is no exception. The 2024 ISPE Pharma 4.0™ and Annex 1 Conference is the
Global Events

Aseptic Processing & Annex 1 (T63)

25 November, 2024

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Classroom Training

Aseptic Processing & Annex 1 Training Course

This course will focus on aseptic processing and quality management around the most important pharmaceutical technology.

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GMP Sterile Pharmaceutical Manufacturing Facility Training C

03 December, 2024

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Classroom Training

GMP Sterile Pharmaceutical Manufacturing Facility Training Course

This course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced...

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3-Day GAMP® Data Integrity 21 CFR Part 11 (T50)

03 December, 2024

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Classroom Training

GAMP® Data Integrity 21 CFR Part 11, 3-Day Training Course

This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems...

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Videos

1 November 2024
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Video

2024 ISPE Year in Review

We. A simple word...yet it holds the power of thousands of minds, hands, and hearts working together across borders and industries. WE are the collective strength of engineers, scientists, researchers, regulators, and...

1 November 2024
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Video

Shape the Future of Pharma - Join ISPE Today!

As the pharmaceutical and biotech industry forges new paths and breaks new grounds, ISPE is here to support you on your journey to Shape the Future of Pharma™. Join ISPE today and leverage the member-exclusive knowledge...

9 October 2024
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Video

2024 ISPE FOYA Category Winner for Innovation: Eli Lilly Kinsale Limited

Internally, this project has been recognized for superior performance with the 2022 Global Lilly IT Award for the project team’s new material tracking system, and the project team was awarded the Lilly Global Safety...

Plastic Process Waste in Biopharmaceutical Manufacturing

This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical industry, focusing on using single-use technologies (SUT) in bioprocessing for monoclonal antibody (mAb) production. It aims to inform sustainable practices within the...

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