iSpeak Blog

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:

Tuesday, 3 June 2014
07.00 – 08.00 Data Integrity-Breakfast Session (Holiday Ballroom 1-3) Assessing Blend and Content Uniformity: Update on ISPE Stratified Sampling White Paper
08.00 – 10.30 Welcome and Plenary Session (Holiday Ballroom 1-3)
10.30 – 11.15 Networking Break (Exhibit Hall, Holiday 4-6)
11.15 – 12.15 Legal Aspects of Data Integrity (Holiday Ballroom 1-3)
12.15 – 13.30 Lunch (Exhibit Hall, Holiday 4-6)
13.30 – 15.00 The Importance of Managing Data Integrity (Holiday Ballroom 1-3)
15.00 – 15.30 Networking Break (Exhibit Hall, Holiday 4-6)
15.30 – 16.00 The Importance of Managing Data Integrity (Holiday Ballroom 1-3)
16.00 – 17.00 Plenary Session-Global Supply & Emerging Markets (Holiday Ballroom 1-3)
17.00 – 18.00 Night Session- Open Discussion ISPE Metrics Follow-Up Peale A-C