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Quantitative Risk Assessment

Quantitative Risk Assessment
Mallinckrodt Pharmaceuticals is a global specialty biopharmaceutical company that develops, manufactures, markets and distributes specialty biopharmaceutical products.
The CMDS (contrast media and medical devices sector) was recently sold to Guerbet Group a research centered pharmaceutical company. This transition helps Mallinckrodt to concentrate their future vision to the acquisition of biopharmaceutical products companies which places them in a very complex and competitive environment with other major pharmaceutical companies. A Quantitative Risk Assessment for the proposed project will estimate the techniques and some of the key variables to determine the risks and losses that will help to present a stronger case for Quality and Regulatory implementation and the personnel improvement required to management. Mallinckrodt has encountered issues with quality and regulatory concerning controlled substances due to employee cutbacks in the manufacturing plants since the CMDS was sold.
Revision of Project Background The proposed project will help define the personnel needed and quality and regulatory requirements needed to run a leaner manufacturing process and address the delivery backlog issues promptly. The success of the proposed project will help the company gain the edge they need to compete in the aggressive competitive opioid and rare disease medicine field.
The quantitative risk assessment can help identify the potential risks the company will encounter if the manufacturing plants are not running at maximum capacity with the required quality and regulatory requirements. The lack of qualified trained and certified personnel in the required quality methods is a risk to the quality of the products. Since the CMDS areas that were sold to Guerbet the manufacturing plants

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