It’s time for another edition of the Reading Roundup featuring the top blog posts from April 2017. Start off your week by kicking back and catching up on what the pharmaceutical industry was reading in April. Serialization Practical Readiness and Operationalization Issues Serialization is a reality – now what? Learn from key industry experts with years of practical experience on working on global serialization implementation issues in a complex regulatory environment. _____________________________________________________________________________________ Pharma: Data Integrity Governance System It is pharmaceutical industry managements’ responsibility to ensure that Data Integrity Governance systems are in place at their respective firms and that this is documented within the firm’s overall Quality Management System. Learn about the different components of the Data Integrity Governance system and the benefits of such a system in ensuring the reliability and accuracy of your data. _____________________________________________________________________________________ Just Published! Pharma Records and Data Integrity GAMP® Guide Get the principles and practical guidance you need to meet current expectations for the management of pharma GxP regulated records and data integrity. _____________________________________________________________________________________ Clinical Labeling of Medicinal Products: EU Clinical Trial Regulation In an effort to harmonize the clinical study drug supply labeling requirements, Chapter X of the Regulation provides rules for clinical labeling. Further, to fill perceived gaps in individual member state requirements, annex VI was added to the regulation with additional detail about clinical labeling requirements. Learn more about the clinical labeling of medicinal products used in European clinical trial regulations. _____________________________________________________________________________________ Quality Metrics Pharma Workshop at Novartis Facilitates Dialog Learn what happened when representatives from pharmaceutical industry, including FDA, gathered for an open dialogue on how quality metrics is impacting the pharmaceutical industry. Get these great articles delivered straight to your inbox by subscribing to iSpeak, the Official Information Resource of ISPE.
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...
