Welcome to the ISPE Indonesia Affiliate. Founded in August 2007, Indonesia Affiliate committed on sharing knowledge on recent technology and current regulation and other pharmaceutical issues to all members, by conducting webinars, in-person seminars, trainings, workshops and conferences.
At the 2025 ISPE Europe Annual Conference held 12-14 May 2025 in London, the European Medicines Agency (EMA)’s Head of Quality and Safety of Medicines Department, Evdokia
Pharmaceutical manufacturers are always under pressure to move faster, stay compliant, and deliver high-quality products in a constantly changing landscape. The Manufacturing
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
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...
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...
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)...
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...
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...
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...