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 14971:2007, 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. |