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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