The mission of the ISPE Southwest Chapter is to provide a dynamic and inclusive forum where professionals can exchange knowledge, expertise, and experiences in the pharmaceutical and biotechnology sectors. We seek to foster an environment that encourages learning, professional growth, and community engagement.
The mission of the ISPE Southwest Chapter is to provide a dynamic and inclusive forum where professionals can exchange knowledge, expertise, and experiences in the pharmaceutical and biotechnology sectors. We seek to foster an environment that encourages learning, professional growth, and community engagement.
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)...
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...
The ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry representatives, for industry use, to provide a practical framework that organizations...
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...
Takeda’s beePFS project is a testament to the company’s commitment to innovation, adaptability, and excellence in project execution. By achieving remarkable success within an accelerated timeline, Takeda has demonstrated...
The facility is designed to be resilient and independent from the electrical grid in times of power outage or emergency. The microgrid allows the facility to operate in "island mode" and use the battery backup system to...
This article offers an overview of the benefits of Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership for regulatory authorities and industry. It also highlights Latin American regulators’ current perspectives on PIC/S membership to increase awareness and...