It’s time for another edition of the Reading Roundup featuring the top blog posts from March 2016. Grab your favorite cup of coffee, kick back and catch-up on what the pharmaceutical industry was reading in March.
All interfaces have the potential to present data integrity issues, due to their nature. Receive suggestions on how to mitigate the data integrity issues for a net result of correct data being available for business personal to make decisions.
Data integrity has become one of the hottest regulatory and compliance topics impacting the pharmaceutical industry in years. To help understand the critical success factors for a corporate data integrity program, the ISPE GAMP® COP released a Concept Paper entitled “Considerations for a Corporate Data Integrity Program”. Learn more about the data integrity concept paper and download it today!
ISPE’s Investigational Products Community of Practice (IP COP) is taking a deep dive into understanding all the ramifications of EU Clinical Trial Regulation No. 536/2014 and the impact it will have on running clinical trials. Read the first installment of the EU Clinical Trail Regulation series.
The final part of the three part series on Non-GMP or GMP Washers and Sterilizers: How to Choose. Part three covers the design, manufacturing and qualification documentation needed on GMP washers and sterilizers. The series also wraps up with helping you decide which option is best for your facility.
Get all of the details on granulation from this in-depth knowledge brief including:
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...
