Presenters:
Mark Frankcom, Adjunct Professor, Virginia Tech University, Center for Applied Health Sciences
Tony Chan, Professor & Director, Risk Management Programs, Virginia Tech University, Center for Applied Health Sciences
Risk Analysis Tools are often used haphazardly and without due regard to their origin and true intent. FMEA is over used and abused. Detection and the state of controls are muddled up. Companies need to adopt a structured approach and train their staff to apply it correctly
At the conclusion of the presentation you will understand:
A structure for the application of risk analysis tools and an understanding of some common pitfalls and how to avoid them.
Your Speakers:
Mark Frankcom was Vice President of Environmental Health & Safety for Amgen, Inc. until 2007, during which he was legally responsible for global compliance with all environmental, health, and safety laws. As an executive leader in developing Amgen's Risk Management Program, Mr. Frankcom had a lead role in the company's pandemic flu response and business continuity effort, worked on Single Points of Failure in the Supply Chain, and developed an internal training program to qualify risk managers, in addition to the development of Enterprise Risk Management. Previously, as Amgen's Executive Director & Head of Corporate Quality, he was responsible for all primary Quality functions to ensure the company's cGMP compliance was in line with FDA, EMEA, and other jurisdictional requirements. He now runs his own consulting business.
Mr. Tony C. Chan, MBA, MSQA, MS Reg. Sc., is Professor and Director of Risk Management Programs at Virginia Tech's newly formed Center for Applied Health Sciences. He is involved heavily with risk management standard activities for medical products both nationally and internationally. His work includes the research, development, training, and implementation of risk, quality and compliance management systems, system approach to total life cycle risk management, hazard analysis and critical control point programs, and a unified enterprise risk management. One of his latest efforts is working with healthcare facilities to prevent medical and medication errors. He was the Quality Development Advisor for the Vascular Intervention Division of Guidant responsible for the Quality Risk Management implementation. He led the implementation of a corporate risk management policy and a comprehensive risk management approach for the total product life cycle of vascular intervention products.