PRESENTATION & DISCUSSION FORUM
Facilitating Data Integrity & Compliance
Duration: Approximately 80 mins
WATCH THE PRESENTATION & FORUM DISCUSSION SEPARATELY!
This expert presentation and discussion forum focuses on data integrity and compliance, particularly in the context of QA/QC, development, and manufacturing. Experts highlight why technology companies need to put the customer at the heart of innovation, to ensure the development of solutions not just products. They examine how different technology can offer benefits for regulatory compliance, with examples of how instrumentation, data integrity and compliance have been combined to provide effective solutions. The event kicks off with the following presentation.
[PRESENTATION] Technological Facilitation of Data Integrity Compliance
Ajaz Hussain (Independent Insights, Advice and Solutions for Science in Life)
Data is the raw material of decisions and claims we make and, in modern society, the basis for being considered good practitioners on actions that others can observe. However, we have not acknowledged that we have been living in the postmodern world for many decades. Now, amidst and beyond the COVID-19 pandamonium, the economic plan is named “the Great Reset,” and “Build Back Better” is the political path forward. We must acknowledge that truth and reality are understood individually and influenced by personal reality, social belonging, gender preference, and culture, which is primed to cancel other realities. Hence, data integrity and truth will exponentially be assured in producing data electronically without human interference. While many parts of pharmaceutical processes and analytical equipment are certifiably compliant with CFR 21 part 11 requirements today, many gaps persist (e.g., mass spectrometers, NMR, IR, and their automation platforms. Historically developing 21 CFR part 11 compliant software has not been a priority for vendors, given that a tiny fraction of their customer base comes from the QC/GMP environment. Placing an added emphasis on the “totality of the evidence” in regulatory science is how we can fairly and responsibly (as per the FD&C Act) progress to mind and fill gaps. Let us make sense of an integrated approach to data integrity in the postmodern world.
[FORUM DISCUSSION] Listen to these experts discuss key issues relating to data integrity and compliance...
By watching the presentation and discussion you will learn about:
- What does data integrity mean?
- What is digitalisation and how is it useful in Pharma for ensuring data integrity
- Strategies for data integrity to assure quality of pharmaceutical products
- How do we improve data integrity?
- Risk to data integrity and methodologies to address them
- How can instrument manufacturers help
- Challenges still facing the industry
'Facilitating Data Integrity & Compliance' is Part 3 of the 'Advanced Pharmaceutical Technologies' series of learning events including presentations and discussions covering transmission Raman spectroscopy, handheld Raman for raw material ID, data integrity and compliance, and dissolution. Click on the buttons at the top of this page to find out more on the other events in this series.