Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche
In the past, in particular larger companies were requested by the authorities to take appropriate measures for ensuring Data Integrity. However, inspectors are now also asking small and medium-sized pharmaceutical facilities to present all DI elements during an inspection, mainly in QC and production. In this context it will be not sufficient to show only high-level documents (DI policy, DI SOP); rather, they are demanding to disclose a well-defined strategy, in which all measures including CAPAs together with a timetable are included.
The webinar will present pragmatic approaches to how data integrity can be defined, maintained and presented in a smaller company without excessive additional financial outlay. The speaker will also highlight some of the topics and issues that may be addressed during an inspection, in particular:
- Structure of the data integrity program
- Which documents are primarily required?
- Prioritization of activities
- Required capacity, timetable
- Data Governance
- Responsibility of the management
- Actions in case of data integrity Problems
The event is aimed at managers and employees of pharmaceutical and medical technology companies who have to implement the current requirements for data integrity in their premises in an inspection-proof manner.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The aim of the webinar is to provide answers to the following questions for practical application:
- Which is the optimal form to present DI remediation measures?
- Documentation of the strategy
- Involvement of the management
- Activities in laboratory and production facilities
- Audit Trail Review - is that really necess
Participants receive an example of a DI Policy and the corresponding DI SOP.