| 09.00 - 09.15 | Introduction / Expectation of the Participants / Aim of the Event |
| 09.15 - 10.00 | Data Integrity in the GMP context – Overview and Regulations Emphasis also on FDA, EU, MHRA, PIC/S and WHO guidelines |
| 10.00 - 10.15 | Coffee break |
| 10.15 - 11.30 | Data Definitions / Types of Data Which data are relevant for Integrity considerations? FDA approach: static and dynamic data. |
| 11.45 - 12.30 | Prevention Strategy – How can DI compliance be achieved within short time? |
| 12.30 - 13.15 | Lunch |
| 13.15 - 14.15 | Control Strategy – Program to ensure Data Integrity. Which documents are essential for the company? Audit Trail Review, Internal Data Integrity Audits. How to report DI issues? |
| 14.15 - 15.00 | Identification of the critical systems: Set the priorities for the DI Program for the next 1-2 years Presentation and interactive creation of a prioritization for all company systems. |
| 15.00 - 15.15 | Coffee |
| 15.15 - 15.45 | Data Integrity Assessment for a System Checklist and practical execution |
| 15.45 - 16.30 | The DI Strategy How to present the Data Integrity program to an inspec-tor? The DI Policy and the DI strategy document – Contents and layout |
| 16.30 - 17.00 | Q & A DI Findings during Health Authority Inspections Practical experience, hot buttons for inspectors |