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Qualification of Analytical Instruments and Personnel
As part of GMP compliance, key elements of the Laboratory Control Systems are Qualified Instruments and Qualified Personnel.
This course discusses theses quality elements in detail. In the qualified personnel section employee qualifications, training, responsibilities and evaluation are presented with respect to cGMP guidelines 21CFR211 and GMP guidelines CO.02.006. Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of laboratory equipment are discussed with examples for specific instruments. This part of the presentation is based on the USP general chapter <1058>. Finally the calibration and maintenance program is discussed.
This course is presented using PowerPoint and includes group discussion and interactive exercises.
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