|Non-ECA Members:||EUR 1990,--|
|ECA Members:||EUR 1790,--|
|EU GMP Inspectorates:||EUR 995,--|
|APIC Members (does not include ECA membership):||EUR 1890,--|
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Even Data Integrity is one of the basic GMP principles since years multiple Data Integrity citations were reported by FDA and European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been and will continue to be the focus of many GMP inspections.
As a consequence international authorities – FDA, EMA, PIC/S, WHO, MHRA - published draft documents to describe the regulatory expectations of Data Integrity.
Although all guidelines are not intended to impose additional regulatory burden to the regulated companies, a lot of uncertainty predominates the pharmaceutical industry how to implement these requirements into the daily business.
The Data Integrity Master Class is directed at