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“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 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?
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.
Dr Wolfgang Schumacher
Dr Wolfgang Schumacher worked for ASTA Medica and F. Hoffmann-La Roche and has more than 30 years of experience in the Pharmaceutical Industry. After a successful career in Cancer Research he focused on the management of national and FDA inspections, auditing of contract manufacturers and the accountability as QP. At Roche he established the IT quality assurance department and was recently accountable in Technical Operations as Vice Director for the GMP/CSV compliance of all global computer systems and the setup of the Data Integrity program, for Genentech as well.