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Evaluate the Environmental Monitoring (EM) program by examining the aseptic filling process and controlled environments, including information on the quality of the aseptic processing environment as well as environmental trends of ancillary clean areas. Cover the establishment of an EM program, training of personnel, data assessment, investigations, and product disposition as defined by regulatory organizations.
Lab Hours: 0.00
Lecture Hours: 12.00
Total Contact Hours: 12.00