It’s time for another edition of the Reading Roundup featuring the top blog posts from May 2016. Grab your favorite cup of coffee, kick back and catch-up on what the pharmaceutical industry was reading in May.
What information does the FDA Data Integrity Draft Guidance provide? What can your company due to create a road map for compliance? Get the inside scoop on how data integrity is impacting the pharmaceutical industry and the resources available to assist you and your company moving forward.
A number of firms have been cited for GxP records in their disposal bins. It is easy to read these observations and conclude they do not apply to your firm – but are you sure? You might have instructed personnel that they must never place a regulated document in the paper bin – but have you also instructed them to do the same with electronic disposal bins – the Recycle Bin in workstation computers? Get the inside scoop on how you should be handling electronic disposal bins.
This four-part series presents and discusses a number of key requirements and design, quality, and engineering considerations that have high importance in end-user usability, cost control and end-product quality that help manage risks in Water for Injection production and processes. Part three reviews:
On 23rd June 2016, United Kingdom (UK) citizens will vote to stay in or leave the European Union (EU). Current opinion polls suggest the public is fairly evenly split on the matter. Learn about how this vote could impact the pharmaceutical industry.
With this discussion paper/survey, we are encouraging the community of Clinical Supply Chain professionals to provide input on the importance and prioritization of the most relevant metrics, potential challenges, and solutions to overcome them, along with how each metric should best be captured for purposes of standardization. Learn about this initiative and participate in the survey which closes on 15 June 2016.
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...
