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Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E 2500-07 ensures GMP facilities and equipment are: "fit for use," perform satisfactorily, and may be used in the manufacturing, processing, packaging, and holding of a drug. This webinar reviews this approach and identifies critical aspects of manufacturing systems that will provide the focus for qualification/verification activities and allow for Good Engineering/Commissioning Practices to apply throughout the project lifecycle. At the conclusion of this session, participants will be able to: