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.
Learn hands-on approaches for identifying, mitigating, and remediating potential causes of breaches in data integrity by participating in the ISPE Data Integrity Workshop on 5 June 2016 in Bethesda, MD. Held in conjunction with the 2016 ISPE/FDA/PQRI Quality Manufacturing Conference*, this special half-day event will identify important regulatory issues impacting data integrity and help answer key questions surrounding current expectations. You will take part in:
This interactive workshop is the ideal place to discuss the current data integrity environment with your colleagues and explore solutions from industry and regulatory leaders. For more information, please visit our website. *Register for both the ISPE Data Integrity Workshop and the ISPE/FDA/PQRI Quality Manufacturing Conference and save $100!
Data integrity is THE question facing regulatory agencies and the pharmaceutical industry. Patients need to trust that the drugs they take have been manufactured according to strict regulation and oversight, that the drugs they put into their bodies are of the highest quality, that all pharmaceutical companies, regardless of geography, have embraced a culture of compliance. Pharmaceutical Engineering®magazine’s six-part special report on data integrity explores this multifaceted subject in detail, describing the desired state, identifying red flags, and enumerating best practices. Our experts define the strategies that drive prevention, detection, and response. View the special report on data integrity today from Pharmaceutical Engineering®magazine with your ISPE membership. Not an ISPE Member? Join today to review the 28-page report containing insight you won’t get anywhere else.
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...