In this program, the concept of change control I presented in a way that places the learner in the role of a change control manager.  Throughout the program, learners learn to state the key elements of a change control program, identify key indicators of change, and learn the regulatory requirements for change control.  The program also defines how to identify the groups involved in change control and way to describe the impact of change on product, process and people.

Topics include:
      ·          The regulatory requirements for change control
      ·          Steps in the basic model of change control
      ·          Indicators of an improper change
      ·          Elements of change control
      ·          Processing and packaging
      ·          FDA notification