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 2017 ISPE/FDA/PQRI Quality Manufacturing Conference offers a new and exciting format where participants will be able to interact directly with pharmaceutical industry and regulatory leaders in a four-series workshop rotation. Today’s blog focuses on the details of Implementing Next Steps for Quality Metrics, one of the four core workshops taking place at the conference. The FDA Draft guidance on Quality Metrics was reissued considering industries comments on the first draft. Now what? ISPE has been leading the charge to bring pharmaceutical industry and regulators together to create an open dialogue about shaping the Quality Metrics program as it is launched industry wide. Industry has given input that the current program is heavy on burden and light on benefit. This is your opportunity to explore and engage in dialog with your peers and FDA on the path forward … to drive greater value out of a quality metrics program for patients, industry and FDA. Objective of the Workshop:
Facilitators:
Tired of listening to talk after talk? Learn why the 2017 IPSE/FDA/PQRI Quality Manufacturing Conference will be unlike any pharmaceutical industry conference you’ve experienced before!
2017 ISPE/FDA/PQRI Quality Manufacturing Conference The 5th Annual ISPE/FDA/PQRI Quality Manufacturing Conference offers you the unique opportunity to interact directly with industry and regulatory leaders to identify real solutions to your organization’s challenges on key issues. Sessions are designed to encourage open discussion about current FDA priorities and industry-critical quality initiatives.
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...