Czech Republic / Slovakia Affiliate

Global News

13 December, 2024
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iSpeak Blog

Peer Companies Share Knowledge on CMO Asset Management and Obsolescence Management in Recent Asset Management Benchmarking Session

In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified through ISPE to explore creation and maturation of Asset Management programs at

13 December, 2024
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iSpeak Blog

Celebrating Excellence: Niranjan Kulkarni, PhD, Recognized as 2024 ISPE Max Seales Yonker Award Recipient

At the 2024 ISPE Annual Meeting & Expo, in Orlando, Florida, this past October, ISPE proudly recognized Niranjan Kulkarni, PhD, with the prestigious Max Seales Yonker Award

11 December, 2024
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iSpeak Blog

Building Resilience in ATMP Manufacturing: Insights and Innovations at the 2025 ISPE Aseptic Conference

Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues, or cells. This class of products cannot be terminally sterilized and, in many cases, cannot
Global Events

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

04 February, 2025

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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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Commissioning and Qualification (T40)

10 February, 2025

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Classroom Training

Commissioning and Qualification Training Course

Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management)...

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HVAC for Pharma Facilities (T14)

11 February, 2025

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Classroom Training

HVAC & Environmental Control for Life Science Facilities Training Course

This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm...

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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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