It’s time for another edition of Reading Roundup featuring the top blog posts of July 2017. Start off your week by catching up on what the pharmaceutical industry was reading in July.
This article from the November-December 2014 issue of Pharmaceutical Engineering® magazine presents a consensus standardized extractables protocol for single-use systems in biomanufacturing. Learn more about how companies are generating SUS extractables testing methods by interpreting regulatory requirements from existing container closure testing methods.
During the Women in Pharma (WIP) breakfast on day two of the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference, 100 attendees gathered for a panel on “Bringing Education to Gender Parity”. Find out what women in the industry had to say as they exchanged their advice and experiences dealing with failure.
On 15 June, ISPE announced the release of their latest publication, ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities. Check out this guide to learn more about the decommissioning and disposing of assets ranging from a single system to an entire facility.
Jim McGlade, Science Client Leader for BHDP Architecture, led the “Proactive Approaches to Facility and Lifecycle Quality Management” Workshop at the ISPE/FDA/PQRI Quality Manufacturing Conference. Find out what he, along with three other experts, had to consider on data integrity, quality systems, and process equipment validation and verification.
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...
