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Location: Building 535Phone: (909) 607-9864
Email: diana_bartlett[at symbol]kgi.edu
Risk Management for Life Sciences
This one day introduction to risk management focuses on the healthcare sectors regulated by FDA. Organized in four parts, the class (1) gives an overview of enterprise risk management and the background to FDA's developing interest in Risk Management; it includes a short case study. (2) introduces participants to a systems approach to risk management, explains the FDA's requirements, and addresses the issue of implementation. (3) looks at the concept of risk acceptance - when is the risk low enough and acceptable? It addresses how management must formally go about accepting risk and has two further case studies. (4) Discusses the process of risk assessment and introduces a framework for using risk assessment tools. Students completing this course will be equipped with a firm understanding of risk management and the critical elements that support it.
Format: One day class with cases and examples.
Business issues: PRisk of any form presents a significant decision-making conundrum to the organization -- but especially to life science companies that rely heavily on future outcomes to grow their businesses. Risk in the regulatory arena is especially challenging and requires a proactive approach.
Who should attend? Experienced life science executives with financial, clinical, or regulatory responsibility. Seasoned project management professionals, operations staff, and business development professionals will also benefit by attending the course.
Fee: $500/person, includes all materials and lunch.
Instructors:
Date & Location: Future dates to be announced