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Course ID:
2052

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Change Control/Deviations

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This course is available as a client site course. Please click here for more information.

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Description
Both the FDA cGMP Regulations parts 210 & 211 and the ICH Guideline Q7A on GMPs for APIs require that there be adequate handling of deviations and change regarding the processing of APIs and drug products and indeed both the handling of deviations and “change control” are quoted as vital sub-systems of the Quality System section of the FDA's System Inspection Program. Both sub-systems are essentially separate in that, whereas deviations are usually batch oriented and need to be resolved prior to batch release, change control is product oriented and usually requires changes to a Master record or an SOP. However, a deviation is a change and any corrective action taken to correct the deviation is also a change with the added feature that if the latter change is product rather than just batch related, then it is subject to conventional change control. Because of this inter-relationship, this course sets out to describe the necessary characteristics of both systems, the first day being devoted to the Deviation System and the second day being devoted to the Change Control System. For both sub-systems the characteristics discussed include regulatory as well as the technical and documentary aspects. The course includes hands-on workshops in dealing with the documentary aspects of both sub-systems.

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