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Validation of Analytical Test Procedures
24-26 September 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:
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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 Objectives
The objectives of this Education Course are
to provide an overview of the current regulatory requirements (CPMP, ICH, FDA, etc.) concerning analytical methods validation
to offer practical solutions for determining the validation characteristics
to discuss the scope of validation necessary to obtain approval by the Registration Authorities (EMEA, FDA, MCA, etc.)
to become familiar with the statistical parameters to be applied
to understand the qualification of laboratory equipment as a precondition of reliable analytical testing
to outline the documentation (SOPs, Validation Protocols and Reports, etc.) which you should have in your lab.
In order to improve the understanding and practical application of the contents of the lectures, workshops will be part of the training course.
Background
Especially the following guidelines established by the International Conference on Harmonisation (ICH) have clarified the expectations of the Registration Authorities:
Guideline Q2A(R2) lists all characteristics to be considered during validation, while Guideline Q2B describes the method of determining the various validation characteristics. Reliable analytical results do not only require validated test procedures but also the use of analytical equipment qualified for its intended purpose. In order to obtain the FDA investigator‘s approval, the qualification of all critical laboratory equipment should be performed in standard IQ/OQ/PQ format. Furthermore, all software used in laboratory analysis must be validated. |
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