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Integrating Analytical Equipment Qualification and Computerised System Validation
19-20 April 2010
Berlin, Germany
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Learning Goals
Analytical instrumentation used within GMP analytical laboratories is computerised either via firmware inside the instrument or via a workstation with software loaded on to a workstation that is situated next to the instrument. However, the current situation regarding the qualification of analytical instrumentation and validation of computerised systems is unsatisfactory; qualification and validation are typically considered as separate activities with little if any interaction between the two disciplines.
For example, the AAPS have produced guidance on analytical instrument qualification (AIQ) that is going to be incorporated as General Chapter <1058> within the United States Pharmacopoeia (USP). This focuses on the instrument with little emphasis on computerised system validation.
In contrast, the GAMP Good Practice Guide for Validation of Laboratory Computerised Systems looks exclusively on the computerised system and ignores the instrument qualification aspects entirely.
The major problem is that you cannot validate the computer system without qualifying the instrument and vice versa.
This workshop will address these concerns and present an integrated approach to analytical instrument qualification (AIQ) and computerised system validation (CSV) for laboratory systems. This will be achieved by presentations coupled with workshops and discussions to reinforce the presentation principles. The number of participants is limited.
Note: this workshop will not discuss directly user training and the writing of SOPs for operating the instruments or systems.
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