Czech Republic / Slovakia Affiliate

Global News

04 October, 2023

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iSpeak Blog

Artificial Intelligence (AI) Based Continued Process Verification (CPV)

Continued Process Verification (CPV) was introduced roughly 12 years ago by the FDA as a third stage in the guidance on the process validation life cycle. In addition to being...

03 October, 2023

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iSpeak Blog

Improving the Gold Standard: A New Portal for ISPE Guidance Documents

At ISPE, our commitment to advancing the pharmaceutical industry has always revolved around delivering gold-standard Guidance Documents — a trusted source of information that...

29 September, 2023

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iSpeak Blog

Meet the 2023 Social Impact Category Winner: Takeda SA

The Facility of the Year Award (FOYA) Social Impact category recognizes companies that accelerated a shift to sustainable facility design, intended to ensure the effective use...
Global Events

10 October, 2023

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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...

19 October, 2023

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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)...

19 October, 2023

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Classroom Training

GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course

The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject...
Videos

26 September 2023

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Video

Shape the Future of Pharma - Join ISPE Today!

Join ISPE's thriving community of pharmaceutical science, engineering, and technology professionals to gain fresh perspectives, international insights, and technical expertise through virtual and in-person engagement...

26 September 2023

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Video

2023 Honorable Mention Winner: Nexus Pharmaceuticals, Inc.

Nexus Pharmaceuticals, Inc. is a woman-led, minority-owned, and family-owned healthcare company and certified diverse supplier based in Lincolnshire, Illinois, USA. Nexus is a uniquely American family company, built on...

17 August 2023

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Video

The New & Improved Guidance Documents Portal

Introducing the Future of ISPE Guidance Documents At ISPE, our mission has always been to connect knowledge, operational excellence and regulatory insights. In keeping with this commitment, we are excited to announce...

Risk Management for Avoidance of Drug Shortages

Shortages of essential medicines around the world have been an ongoing concern for patients, caregivers, and regulators and have been exacerbated by the COVID-19 pandemic. Many regulators have instituted requirements for reporting potential or actual...

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