Data Integrity – General Training

This is how your training course could look like:

Do you need an individual offer for your company?

Send us an e-mail indicating your topic(s) of interest.

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

 

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