New Jersey ISPE is an organization of, and for, professionals in the ever changing Life Sciences Community. As such, we strive to provide value to our various constituencies – owners, consultants, designers, contractors, vendors, students and the un- and under-employed.
New Jersey ISPE is an organization of, and for, professionals in the ever changing Life Sciences Community. As such, we strive to provide value to our various constituencies – owners, consultants, designers, contractors, vendors, students and the un- and under-employed.
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
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
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
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...
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...
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...
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...
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...
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...