Dr Wolfgang Schumacher, Form. F. Hoffmann-La Roche
“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.
The audience of this Webinar should be collaborators from QC, QA, production and IT, which are dealing with data integrity and the review of Audit Trails, are engaged as system administrators or manage computer systems in the GMP area.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
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:
- Regulatory Overview with emphasis on the requirements of FDA, PIC/S 041, Annex 11 und MHRA
- New requirements in PIC/S 041
- Classification of data – which are critical data?
- What Audit Trails are of importance in production and QC/QA??
- Who shall review Audit Trails?
- How is the review documented?
- What process and documentation is appropriate in case of deviations?