Understand the Risk-Based Process Validation Life Cycle Approach
Line Lunsberg-Nielson, Principal Consultant, NNE Pharmaplan, shares the key takeaways of ISPE’s Process Validation training course. Lunsberg-Nielson has been a member of ISPE for more than 15 years, serving in many roles. She was member of the ISPE PQLI Technical Committee, past chair of the PQLI Control Strategy team, and has recently been one of the authors of ISPE’s Process Validation Course that she also teaches. ISPE’s 2017 line-up of Validation training courses include:
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...