The biopharmaceutical industry has many challenges including technical, organizational and societal. This fast paced industry is continuously buffeted by new product developments, technological changes, as well as evolving patient requirements and aggressive industry competition. To help address these many challenges an approach was developed using off-the- shelf tools (Excel, Primavera and Pertmaster) to achieve a standard and straightforward methodology to insure consistent, reliable risk management and establish a basis for continuous management of risks throughout the project life. Benefits include a clear and easy to use risk register with responsible risk owners and risk ranking for focus and mitigation; simulation of project cost and schedule impact via project risk models to facilitate decision-making; promotion of active participation from a diverse user group, and the opportunity to focus the combined knowledge and experience of the team to enhance project performance. This approach ultimately transformed risk management from a negative paradigm into a positive, synergistic, team building, group educating, and solution-generating experience.
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