AAMI Training Presents: Integrating Risk Management into the Product Lifecycle and Quality Management System
Event Overview
Join us a develop a comprehensive understanding of risk management concepts used throughout the quality management system to consistently meet FDA 21 CFR 820 regulations and ISO 13485 requirements utilizing ISO 14971 and ISO 24971. Attendees will learn how to use risk management files and risk analysis concepts to make risk-based decisions for medical device product realization and other quality management system process decisions throughout a device's lifecycle.
Benefit from the insight of AAMI Faculty and FDA representatives as you learn detailed risk management concepts used throughout the quality system that can help your organization meet FDA and ANSI/AAMI/ISO 13485:2016 requirements for risk management using ANSI/AAMI/ISO 14971:2019 and ANSI/AAMI/ISO TIR24971:2020.
This course will cover risk management principles used throughout the lifecycle of a product (design, manufacturing, post-production, and retirement). Instructors will also identify linkages between risk management processes and quality system processes. Participants will discover how to use regulatory databases to support risk management activities at different stages of the product lifecycle, as well as the use of International Product Safety Standards.
To Register:
Integrating Risk Management into the Product Life Cycle - AAMI Training | AAMI
Registration Fees Apply: $2,935.00
Hands-on activities with a medical device within the class will enhance the learning experience by:
- Identifying hazards and hazardous situations through evaluation of a medical device design in normal and fault conditions.
- Confirm harms using regulatory databases and international safety standards to design a safer device.
- Consider the manufacturing processes to identify hazards that could be introduced into the medical device and how to prevent them.
- Develop and challenge benefit-risk analysis of real-life situations during post-production.
Program Objective
- FDA and AAMI faculty work together to help the learner understand:
- Basic terms of risk management, how they relate to each other and how to use risk management throughout the quality system to make risk-based decisions for product realization from cradle to grave.
- How to use a variety of risk management tools to support risk-based thinking and decision-making through exploring typical scenarios in which the tools can be most useful.
- FDA's expectations for submissions and compliance, as well as how to apply risk management principles to various aspects of a quality system as required by the FDA and ISO 13485:2016,
- The current state of risk management based on ISO 14971:2019 and other applicable product safety standards including those related to processes and those related to specific medical device products.
- How risk management is audited during MDSAP audits and how that relates to country-specific requirements for risk management activities or risk-based decisions.
Target Audience
Instruction is targeted to medical device manufacturers and suppliers to medical device manufacturers, quality assurance and regulatory affairs personnel, design and process engineers, manufacturing and operations managers, members of research and development or new product development teams, and individuals responsible for supplier controls and post market activities. For participants to gain the maximum benefit from this course, it is recommended that they have a working knowledge of the Quality System regulation and design controls or have already attended AAMI's Quality System and Design Control courses.
Format
Learning objectives are delivered in a highly interactive format that includes relevant examples from a broad product spectrum that demonstrate current industry practices of risk management throughout the quality system and product life cycle. In addition, interactive, hands-on exercises will allow participants to practice applying risk management concepts, principles, and tools throughout the product life cycle and the quality system.
Materials
Your fee includes a comprehensive eNotebook of all training materials and many of the referenced materials, including FDA, Global Harmonization Task Force, and IMDRF guidance documents relevant to the course, all in one easy-to-find location with download options. A copy of ANSI/AAMI/ISO 14971:2019 is also provided.