Featured in this edition of iSpeak Reading Roundup, are the top blog posts from July 2019. See trending ideas for regulatory compliance, biopharmaceutical innovation, and more for what the pharmaceutical industry was reading last month.
Explore the innovative software that will change the future of bioprocess planning and data collection. The bioprocess digital twin is a mathematical model that utilizes current manufacturing data and can better predict process chain outcomes.
Process verification and validation methods are crucial for any organization’s success with today’s complex supplies and equipment. See how continued process verification can help the industry avoid challenges and optimize the potential for regulatory compliance.
Hear from Robert Beall as he shares why process validation and the lifecycle approach are critically important for reliable manufacturing, product sustainability, and quality assurance.
Read about key details to new CT application, timelines, and requirements for the application process of EU clinical trials. Updates and additional information for the EU Clinical Trial Regulation are featured in this article.
Discover the impact of cutting-edge technologies, new production methods, and the latest advancements towards the future of biopharmaceutical manufacturing. This article highlights topics discussed at the 2019 ISPE Biopharmaceutical Manufacturing Conference in Boston.
The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...
The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...