Lab Equipment Qualification 8-10 October 2008 Prague, Czech Republic Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 1990,--) Book this option: ECA Members (EUR 1791,--) Book this option: EU GMP Inspectorates (EUR 995,--) Book this option: APIC Members (does not include ECA membership) (EUR 1891,--)
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Learning Goals Calibration and qualification of equipment are key requirements in GMP guidelines (EU GMP Guide, Annex 15 to EU GMP Guide, and FDA‘s Code of Federal Regulations, 21 CFR Part 211). These requirements also apply to equipment and systems in analytical laboratories of the pharmaceutical industry. Besides calibration and qualification, the validation of computerised systems is another key issue. The software components associated with the instruments and systems must be shown to be fit for their intended purpose. Computer validation requirements and guidances for the pharmaceutical industry are laid down, amongst others, by the EU (Annex 11 to EU GMP Guide), the PIC/S (Good Practices for Computerised Systems in Regulated “GXP” Environments”), GAMP (Good Automated Manufacturing Practice), and FDA‘s Part 11. In 2006 the United States Pharmacopoeia (USP) has published a new General Chapter <1058>, Analytical Instrument Qualification, which is likely to be adopted in the first supplement of USP 30. The objective of this course is to provide the participants with an overview of the regulatory requirements on the qualification of analytical equipment and the software validation of computerised systems and to give practical advice on successful approaches to calibration, qualification, validation, and routine monitoring of instrumentation and systems. Key requirements of the new USP General Chapter <1058> will be presented and discussed. The course will cover the following instruments and systems amongst others: Spectrophotometers (UV/VIS, NIR and IR) Balances and Masses pH HPLC and TLC Chromatographic Data Systems Excel® Spreadsheets Interactive workshops will allow the participants to discuss key areas of interest and to exchange practical experiences.