Presenters: Mark Frankcom, Adjunct Professor, Virginia Tech University, Center for Applied Health Sciences and
Tony Chen, Professor & Director, Risk Management Programs, Virginia Tech University, Center for Applied Health Sciences
Risk Management is everywhere today from terrorist threats to financial meltdowns. In the Healthcare sector the increased threat from counterfeit medicines and adulterated raw materials requires a strong response. There are emerging expectations on what is required and standards are beginning to develop. How can companies effectively understand their risks and learn to mitigate them effectively? There are several basic steps to follow to become effective and protect your company.
This webinar will explore the current regulatory expectations and provide guidance on roles and responsibilities with particular attention to the role of Executive Management. While discussion will focus on the Healthcare sector, many of the lessons are broadly applicable in all industries.
At the conclusion of the presentation you will understand:
How to create a risk management system which is effective and efficient - including management review, using alerts and case studies and communicating effectively.
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. Chen, 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.