Webinar: Audit Trail Review - Update 2019

“Data Integrity” is still one of the major topics during inspections by the American FDA and European health regulatory bodies. Last year a number of guidelines were published in their final versions; therefore, it was expected that the subject “Audit Trail Review” was clarified and can be considered as resolved. Unfortunately, despite these new guidelines, the implementation of a compliant and manageable audit trail review in the pharmaceutical industry is not well defined, in particular for companies exporting products to foreign markets. The requirements of the FDA are - to some extent - in contrast to those of European authorities. In this respect the PIC/S document 041, which was published in its draft version 3 at the end of 2018, created more confusion than clarity, e.g. for the management of scanned documents. 

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.