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Date: 2nd - 4th July, 2008

Location: Berlin, Germany

Summary:
Pharmaceutical - Training, Seminar

Learning Goals:
Two of the major computerised systems used in GMP- and FDA-regulated laboratories are chromatography data systems (CDS) and laboratory information management systems (LIMS). However, how effective are these systems used either individually or in combination?

Today's pharmaceutical companies are suffering from reduced profit margins as a result of healthcare cuts by government agencies. This requires internal efficiencies to maintain profit levels. In addition, there are regulatory drivers to maintain or improve regulatory compliance as well as submit records in electronic format instead of the traditional paper form.

In addition, regulations are being interpreted differently (e.g. FDA's GMP regulations) or being revised (e.g. 21 CFR 11 for electronic records and electronic signatures and EU GMP). How will these impact CDS and LIMS applications?

The course looks at both IT and analytical issues facing analysts, managers and QA working in today's GMP- and FDA-regulated laboratories within pharmaceutical organisations. It focuses on issues that impact CDS and LIMS separately as well as when they are integrated together.

The aim of this course with workshops to reinforce key learning points is to assess how to improve the effectiveness of these applications used individually as well as in combination.