Course Dates Upcoming Dates and Locations Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times. There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!
Course Details Objectives Understand regulatory risks and hazards Learn how to create a risk management plan and risk management report Be able to perform risk analyses, risk evaluation, and risk control Know how to prepare a combination design/process failure mode and effects analysis (d/pFMEA) Be able to conduct the post-production risk assessment Topics Fundamental risk management concepts and definitions Global regulatory compliance requirements for risk management, including US, EU, and Canada How the FDA and other global regulators interpret risk management The evolution of ISO 14971:2012, its purpose, and the differences between the 2007 and 2012 versions, including a comprehensive review of the key clauses and annexes Elements of an effective risk management plan Integrating risk management into your product development life cycle and quality management system Requirements for each step of the risk management process, including risk management plan, risk analysis, risk evaluation, risk control, risk management file, and post-production analyses The impact of postmarket activities on risk, including postmarket design, CAPA activities, and governmental postmarket surveillance The major tools and methods of risk analysis and hazard analysis: estimating, evaluating, controlling, and reducing risks ISO 13485 and risk management Who Should Attend Recommended for design managers and engineers; manufacturing, service, quality assurance, reliability, research and development, and regulatory affairs professionals, and other cross-functional team members in a medical device environment. Virtual Half-Days In-Person Full-Days CEUs 1.5
Related Courses Implementing Design Control Requirements and Best Practices Developing and Maintaining a Compliant Document Management System Implementing CAPA Programs for the Medical Device Industry Root Cause Analysis for Life Science Investigations