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|