This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971:2019 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design to manufacturing through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes. Students will discover how to use regulatory databases to support risk management activities at different stages of the product life cycle, as well as the use of International Product Safety Standards during risk management activities.

For more info:  https://aami.org/training/training-suites/quality-systems/risk-management

This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience.

Program Objective 

Upon completing this course, participants will be equipped with the information to able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet requirements.

This highly interactive course engages the learner with in-depth discussion of industry best practices to learn how industry leaders address design control challenges. Exercises are designed to build a solid understanding for developing and applying design control requirements. Attendees will participate in structured discussions with their peers to develop solutions to solve current issues.

For more information:  https://aami.my.site.com/s/lt-event?id=a1YUW00000F91Aq

This 3-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Topics include planning, protocol development, validation execution, monitoring & control and re-validation to meet the FDA’s expectations and the industry’s best practices.

Program Objectives
FDA and AAMI faculty work together to help the learner to:
– Determine which processes require validation and develop a Validation Master Plan
– Develop protocol content to ensure a successful validation
– Document the results and the resolution of deviations that occur during validation execution
– Plan for effectively monitors and controls for their validated processes
– Determine the re-validation requirements for product and process changes
– Planning, Protocol Development, Validation Execution, Monitoring & Control and Re-validation to meet the FDA’s expectation and industry’s best practices
– Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation post-course test. This optional, one-hour, self-assessment tests your mastery of the course materials and your ability to correctly interpret the Quality System Regulation and ISO 13485 Standard.

For more information:  https://aami.my.site.com/s/lt-event?id=a1YUW00000EsRft