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The integrity of data is one of the key principles of GMP which got lots of attention by the Health Regulatory Bodies in the past three years. The large number of FDA Warning Letters and Non-Compliance Reports created by the EMA are an indication for the existing compliance issues which are reported for all countries.
As a reaction on the problems discovered, the Regulators started to define their requirements for the data life cycle and expectations how they should be met by the pharmaceutical industry. A real “Tsunami” of drafts of Guidelines and Guidances (FDA / PICS / MHRA / WHO) was coming up creating lots of uncertainness on the industry side.
The Webinar aims to focus on presenting the data integrity developments of the past two years and evaluate their impact on the industry. A number of first-line activities to establish a data integrity strategy will be presented; the discussion will also highlight actions in case of DI issues:
Introduction – The Data Integrity Hype
Regulatory update – What’s new? / Highlights
PIC/S / FDA / Annex 11 Revision
How to deal with copies and scans?
Static / Dynamic Data
Recent regulatory observations – from lab to production
The data integrity strategy
Prioritization of systems and risks
Initial management activities – policy / strategy / training
Initial IT activities – administrator / annotation function
How to deal with data integrity problems
Management of health authorities
Internal recording and documentation
The audience of this Webinar should be collaborators from QC, QA, production and IT, which are dealing with data integrity, are engaged as system administrators or manage computer systems in the GMP area.
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.