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 What You Will Learn At the end of this workshop, you will be able to: Identify integration of risk into the US FDA quality system regulation (QSR) Identify similarities between the ICH series and ISO 13485 in quality risk management Describe the key concepts of ISO 14971 and ISO/TR 24971 – including the definitions for benefit, state of the art, and reasonably foreseeable misuse – and the expanded requirements for production and postproduction activities Describe the risk management process, including planning, analysis, evaluation, control, benefit-risk, and residual risk analysis; risk management review and reporting; and production and postproduction activities Describe how to use the process and risk-based approach of ISO 13485 and ICH Q9 to ensure the continued suitability, adequacy, and effectiveness of your risk management process Apply risk management to product safety using ISO 14971 by creating a risk management plan, applying tools for risk assessment and risk control, conducting a benefit-risk analysis, and creating a risk management report Who Should Attend Anyone from the pharmaceutical and medical device industries involved in development of combination products, including regulatory personnel. Recommended for design managers and engineers; manufacturing, service, quality assurance, reliability, research and development, internal auditors, and regulatory affairs professionals; and other cross-functional team members in combination product manufacturing. All attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485 Virtual Half-Days In-Person Full-Days CEUs 2.4
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