Data Integrity
Date:
Thursday, December 11, 2025
Time:
10:00 AM PST | 01:00 PM EST
Duration:
60 Minutes
More Trainings by this Expert
Product Id : 508044
Price Details
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Overview:
Covers the regulations and how to detect Data Integrity. What to do if found.
What to do to promote preventive measures.
Why should you Attend:
Data Integrity is a major issue in the pharma biotech vaccine industry where the date has been intentional or unintentionally corrupted.
This leaves the product misrepresented in terms of its value as a drug or medical product. This could lead to the product being withdrawn from the market and recalls due to mislabeling for example. In bad cases this would be a serious citation that could lead to a warner letter being issued.
Areas Covered in the Session:
- Inspection Awareness
- Measure of what Constitutes Data Integrity
- Detection Tool
- Preventive Measures
Who Will Benefit:
- Manufacturing Staff
- QA & QC Staff
Speaker Profile
Nigel J Smart PhD is the President of SMART Pharmaceutical Consulting, a West Chester, Pennsylvania, USA Life Sciences consulting firm.
He is a serial entrepreneur with decades of experience in the biotechnology/pharmaceutical industry; many of those based in North America in both corporate and consulting capacities. He consults on a variety of Life Sciences topics with particular interest in Lean and Performance strategies in Bioprocess Development/Manufacturing, in addition to the application of Quality Compliance principles to modern processes. In relation to these topics, he is particularly focused on digital applications associated with generating what he terms Powerhouse High Performance outcomes. In relation to Quality Compliance, Nigel has acted as an expert consultant for the FDA on cGMP and Data Integrity issues and assists both domestic and foreign companies with sustainable Quality Compliance strategies. As part of his government service, Nigel has assisted both the Biological Advanced Research & Development Authority (BARDA), and the Department of Defense in the relation to the production of anti-terrorist countermeasures. He has a special interest in the application of LEAN Process Excellence principles to Bioprocess Manufacturing systems and is the author of a book dedicated to this topic entitled “Lean Biomanufacturing” Oxford Health Publishers.
