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Pharmaceuticals, Medical Devices

Application of GMP to Microbiology Laboratories (EU)

About the Course

This eLearning module addresses the application of Good Manufacturing Practices (GMP) and general principles to microbiology. Aspects of laboratory operations specifically required by GMP and considered industry practice will be reviewed, including general requirements for microbiology laboratories, documents and document control, handling of raw data, and laboratory control. This training course will cover general laboratory control issues, and GMP requirements for topics such as handling of chemicals, documentation practices, sample handling, prevention of cross-contamination, positive and negative controls, identification tests, sterility tests, handling of media, laboratory equipment, autoclaves, and environmental monitoring. This will be an excellent overview of specific laboratory requirements. The module covers requirements of the European Union (EU) and the U.S. Food and Drug Administration (FDA).