World Class Risk Management - What The Best International Standards Say About Risk (COM)


Sep 14, 2017 – 8:30 AM - 4:30 PM

Chicago, Illinois, United States
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Are you a Supervisor, Manager, or Director with risk management responsibilities? Do you have questions about what you are doing and why? If the answer is “yes,’ then this is the right course for you!

Risk management is a defining attribute of the 21st century. Many companies and organizations are going through growing pains attempting to implement effective and sustainable business practices. While the concepts may seem to be simplistic, the implementation in an organization can be very daunting.

What is unique about this course?
First, this course is not a "cook book" approach. The course is meant to teaching "risk-based thinking" (as described in ISO 9001) which is being implemented throughout the world.
Second, this course is practical. There are many theorists that have parochial approaches. This course teaches the proven and broadly accepted strategies to manage risk.
Third, this course designed for a wide audience. The course is designed for personnel from all organizations and companies with no prior formal education in risk management required.

In this two-day workshop conference, you will learn strategies for success in your organization.
How should the corporate risk process be integrated into specialty areas such as Operations, Human Resources, Project Management, Strategic Planning, and Safety and Health?
How do we deal with non-linear issues such as those with low probability, yet catastrophic severities?
What tools are available to facilitate formal risk management in the organization and how to implement them?

Learning Objectives:
Upon completion of the course, the participants should:
Understand risk-based thinking and compliance risk
Understand what the global expectations of risk management are regardless of industry or organization.
Utilize a risk based approach to developing an effective and scientifically valid risk management system
Evaluate effectiveness, suitability and adaptability of the risk management system in a variety of applications and across multiple fields of study
Using good risk management principles to manage the supply chain, to enhance success with vendors and contract manufacturers.
Understand the difference between acceptable risk-based thinking and significant deviations from the accepted industry practice
Understand how risk management has been implemented in different industry sectors and in different countries around the world
Investigate methods to identify true root causes of problems and to evaluate and prioritize solutions
Implement formal methods for decision-making
Develop successful implementation plans
Perform risk assessments effectively
Communicate risk results both within and without the organization

Who will Benefit:
This course is designed for senior executives, directors, managers, and those tasked with developing, maintaining and/or improving risk management activities in their organization. Additionally, this may include individuals that have Quality Management Systems responsibilities as well as those whose roles may include Safety and Health. The following personnel will benefit from the course:
Risk managers
Risk professionals
Safety and Health professionals
Project managers
Compliance managers
Operations personnel
Quality system personnel
R&D personnel
Human resource personnel

Day 01(8:30 AM - 4:30 PM)
Registration Process: 8:30 AM
Introduction to risk management
Defining the what, how and why we got to this point with risk management
Key concepts
Review of several risk management standards
What are the universal principles?
Where are they different and why?
Topical Review:
Decision-making in risk management
Fault Tree
Monte Carlo
Design of Experiment
Root case analysis
Frameworks for effective risk management
Common elements
Establishing the organizational framework
Designing the program
Fundamental considerations
Policies and procedures
Risk Management is the critical tool for the whole organization

Day 02(8:30 AM - 4:30 PM)
Implementing the program
Common cause failure modes and how to avoid them
Dealing with organizational inertia
Establishment of a baseline risk assessment
How to assess the adequacy of the assessment
Do we know enough?
Evolving to a living risk management process
Risk as Opportunity
The concept of positive risk
Turning opportunities into strategy
Risk Treatment Strategies
Risk sharing
Controlling Risk
Effective monitoring
Tracking cost savings and cost avoidances
Integration of Health and Safety
Use of statistical cost of human life around the world
Sector-specific issues
Case Studies
Reports of successes
Significant failures
Auditing Risk
Separating the critical from the important
Communicating risk about risk management
How to change the system
Incremental changes versus the revolutionary change
Moving the prototype to full operation
When to change and when to leave as is
Stan Mastrangelo

Stan Mastrangelo
Technical Committee Member of working group on ISO 31000, ISO 14971, and ICH Q9 Standards
Stan Mastrangelo has over 30 years of professional work experience in Quality Assurance of medical devices, pharmaceuticals, and foods. Stan has held positions such as Senior Quality Engineer, Corporate Quality Assurance Auditor, Plant QA Manager, QA Director, and Consultant. Stan was a member of the ANSI Executive Standards Board. Stan has had extensive involvement in the development of International Risk Management Standards. Stan was a member of the ISO Joint Working Group for Risk Management of Medical Devices (that developed ISO/IEC14971). Stan was a committee liaison to the ISO Technical Management Board Joint Working Group on Risk Management that developed ISO 31000 which is the Risk Management Standard for all sectors. Stan was on the US PhRMA (Pharmaceutical Research and Manufacturers Association) Team that supported the development of ICH (International Conference for Harmonization) Standard Q9 titled Quality Risk Management for Pharmaceuticals. Stan also served on various IEC Standards Teams related to IEC 60601, IEC 80001 and Risk Management in the Software Lifecycle. Stan is an Adjunct Professor at Virginia Tech and was a co-developer of a Masters Degree Program in Medical Product Risk Management. Stan is on the Risk Management Committee for the IECEE.

Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

This Event Listing is Promoted by
New York Media Technologies LLC in association
$1,689 – $5,989

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