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The topic “data integrity” is at present one of the major focal points in national and international Health Authority inspections. The pharmaceutical industry has already started to implement measures in Quality Control and the Quality Unit to ensure the integrity of data for the paper based documentation and the computerized systems. Recently, the Health Regulatory Bodies have started to check more frequently systems in the manufacturing, the quality control area and in the clinical sector . In these inspections emphasis is made particularly on data and parameters that could influence the patient safety. The topic “audit trail review” continues to lack a comprehensive definition in the guidelines; therefore many companies are investing more capacity in the routine control of audit trails than requested by law.
The audience of this Webinar should be collaborators from QC, QA, production, clinical research/monitoring and IT, which are dealing with data integrity and the review of Audit Trails, are engaged as system administrators or manage/monitor computer systems in the GMP and GCP area.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.htm 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 Webinar aims to focus on the critical elements of data integrity and Audit Trail Review: