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Please note that we need about 3 months preparation for the organisation of your in-house training course.
|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