Pharma Change Control - FDAnews
In order to successfully introduce a change control program, you must have the support of the com-pany’s top managers. The program also needs a corresponding statement for quality management (see Figure 2). Many types of changes affect several regulation areas simultaneously (e.g. GMP requirements,
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Managing Change and Transition - University of Victoria
www.uvic.caChange teams are set up as needed (e.g. implementation, transition, communication, etc.) The need for the change has been effectively established and communicated to everyone – more than once using a variety of medium. The impacts of the planned change - indirect, as well as direct - have been identified and communicated.