Day 2: Ensuring Data Integrity

Another busy day awaits us at the 3rd Annual ISPE-FDA CGMP Conference. Today’s theme is Data Integrity where attendees will hear presentations focused on the implications of data integrity from experts who will present a series of talks throughout the day. The sessions begin at 08.00 in the Holiday Ballroom 1-3 with session moderators, Thomas Cosgrove, J.D., Acting Director, Office of Manufacturing and Product Quality and Elaine Eborall, Ph.D., Senior Director, Vertex. The moderators will open with a review of the definitions and regulations, regulatory perspectives and consequences, data integrity audit techniques and wrap-up with points to consider before introducing the remaining presenters. Gerald Heddell, Director, Inspection, Enforcement and Standards, MHRA, will speak after the welcome with a discussion of the European Union’s perspective on the foundations of data integrity, the global problem of data fraud, types of data fraud and the impact of falsification. Here is a complete overview of the schedule for today: