2-Day Advanced Course World Class Risk Management - What The Best International Standards Say About Risk - ISO 31000, ISO 14971 and ICH Q9


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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:

  • Auditors
  • 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
      • HACCP
      • HAZOP
      • FMEA
      • 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
Seminar (Price/Register)
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Other Registration Option
  1. Download the Order Form
  2. Fill this form with attendee details & payment details
  3. Fax your PO to 1-888-883-7697 or,
  4. Email it to cs@compliance.world

Payment Mode

By Check -

Pay your check issued from the payee to "Redstone Learning Inc." (Our Parent Company) and mail the check to –
Compliance.world (Redstone Learning Inc.)
1180 Avenue of the Americas,
8th Floor, New York,
NY 10036

  Media Partners

If you wish to partner with us for this event

please contact us: partner or
call us: 1-866-978-0800

Media Partner Benefits

  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner to do

  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

  Sponsors

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please contact us: sponsor@compliance.world or
call us: 1-866-978-0800
Speaker: Stan Mastrangelo, Technical Committee Member of working group on ISO 3100

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.


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