Risk Management and ISO 14971 in a Nutshell

Pre-Recorded CD Webinar
Approximately 90 minutes in length, Self Examination and Answer Key Included

Who Will Benefit:

This training solution will benefit professionals in the following industries:
Medical Device, Pharmaceutical, Human Tissue, Biotechnology.

In departments such as:
QA/QC/RA, Manufacturing/Operations, Research and Development, Legal

With job functions:
Department managers and supervisors, QA/QC/RA specialists and engineers, Manufacturing, Process and R&D engineers, chemists, scientists, formulators, documentation specialists, auditors, technicians.

Learning Objectives:
Participants of this course will learn key concepts essential for the deployment and smooth continuous operation of a Risk Management System. Specifically, they will understand:

  • “Why” Risk Management is critical to the effectiveness of your Quality System.
  • “What” are the Four Steps of a Risk Management System, the Essential Components of each of these Four Steps and the Risk Management Lifecycle.
  • “How” to perform and document a Preliminary Hazard Analysis, evaluate identified risks, determine ways to reduce risk and measure this reduction.
  • “When” the Risk Management Process should be initiated, risks must be mitigated or controlled and the Risk Management Process ends.

Course Description:
With the advent of ISO 14971, both the US FDA and the European Regulatory Authorities have made it clear that Risk Management is expected. This course will examine the current industry-regulatory environment and give you tools for survival; it will provide a step-by-step guide to setting-up, operating, and managing a Risk Management System. Further, this course provides “content understanding” so important when auditing Risk Management Systems.

  • Section 1:
    • Background-Regulatory Requirements
    • What is Risk Management, anyway?
    • What are the Four Steps of the Risk Management Process?
    • Step One: What do you mean I need a Risk Management Plan?
    • Step Two: Risk Assessment. Let’s illustrate the Concepts
  • Section 2:
    • Step Two: Risk Analysis. A simple example.
    • Step Two: Risk Analysis. How do I Perform and Document It?
    • Step Two: Risk Evaluation. So does it Matter?
  • Section 3:
    • Step Three: Risk Control. How do I mitigate an identified risk?
    • Step Three: So did it help?
    • Step Three: And I need to document it?
    • Step Four: When does this all end?

Order On-Line to Own This CD Webinar: $195.00