Review and Implementation of USP <1058> Analytical Instrument Qualification 2011

Why Should You Attend:

This course is designed to provide participants with an understanding of USP General Chapter <1058> Analytical Instrument Qualification and practical approaches to successful implementation.

The course will describe the steps in the qualification process, and the roles and responsibilities of various groups in this process. We will touch on requirements for instruments with firmware or instrument control, although the validation of stand-alone software is outside the scope of this course.

Examples of documentation will be provided, with practical suggestions for some common laboratory instruments. Change control will be discussed, including addressing maintenance, preventative maintenance and periodic requalification. There will also be discussion on what to expect, related to instrument qualification, during an FDA inspection.

Duration:

4 hours of instruction, and breaks as appropriate.