Laboratory Control System Training Course :

Laboratory Control has been the largest identifiable area of cGMP observations of non-compliance during FDA inspections for the past decade. Recently the FDA changed its inspectional technique to focus on systems. The emphasis of this seminar will be the Laboratory Control System identified in the FDA Systems Inspection Program and the relationship of the Laboratory Control System components to the cGMPs (21CFR210 and 211) and FDA and ICH guidance documents. Discussions include examples of investigational observations. Discussions, workshops and course notes include assessment checklists.