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PME 590:Risk-Based Compliance in the Pharmaceutical Industry
Course presents Quality Risk Management, including Risk-Based Compliance for Cross Contamination, Occupational Safety, and Environmental Protection. Addresses the issues of occupational exposure to high hazard pharmaceutical compounds, and product-to-product cross contamination in multipurpose facilities. Explores issues that a pharmaceutical professional needs to understand regarding projects that put the workforce or product at risk and, in the case of product exposure, impact product quality and regulatory scrutiny. Included are emission sources and essentials, routes of exposure, toxicology, safety and regulatory limits of exposure, exposure control for facilities and processes, quantitative risk assessment, and mitigation techniques. |