San Diego Chapter

Global News

02 June, 2025
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iSpeak Blog

A Visit to 中外製薬工業株式会社 Chugai’s Award-Winning Tokyo Facility: A Benchmark in Social Impact and Excellence

A Message from the President and CEO, ISPE - In late May, I had the distinct pleasure of visiting 中外製薬工業株式会社 Chugai Pharmaceutical Manufacturing Co., Ltd.’s UK4 biological

22 May, 2025
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iSpeak Blog

Navigating the Horizon: ISPE’s Vision for Tomorrow

Navigating the Horizon: ISPE’s Vision for Knowledge, Community, and Innovation For centuries, explorers have scanned the horizon in search of opportunity and clarity. At ISPE...

01 May, 2025
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Features

Streamlining the Vein-to-Vein Process: The Future of Automated Cell Therapy Manufacturing

Cell therapies, especially autologous chimeric antigen receptor T cell (CAR T cell) treatments, are transforming personalized medicine, bringing new hope to patients with
Global Events

Pharma Facilities Project Management (T26)

03 June, 2025

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Classroom Training

Pharma Facilities Project Management Training Course

Specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project...

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3-Day GAMP® Data Integrity 21 CFR Part 11

24 June, 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)

14 July, 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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Videos

10 April 2025
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Video

Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition

This third edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends to further reinforce the concepts described in the second edition of the Guide, provide examples of how these concepts...

23 January 2025
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Video

2025 ISPE Annual Meeting & Expo - What to Expect

Discover why the 2025 ISPE Annual Meeting & Expo is a can't-miss event. Find opportunities to connect with global industry leaders, participate in exclusive events, and elevate your career through unparalleled networking...

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...