AAMI's quality systems training gives medical device design and manufacturing professionals the tools and knowledge to maintain regulatory compliance with all applicable FDA and ISO requirements. Our course content was developed with the guidance of experts from leading device manufacturers, the U.S. Food and Drug Administration (FDA), and members of standards development teams.
Quality System Regulation: Navigating 21 CFR 820 and ISO 13485
Learn how to develop and maintain a Quality System management program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and the international quality management standard, ANSI/AAMI/ISO 13485:2016.
Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485 (Apr23)
April 17 to 21, 2023Register
Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485 (Aug23)
August 21 to 25, 2023Register
Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485 (Dec23)
December 11 to 15, 2023Register
Process Validation Requirements and Industry Practices
Obtain practical tools and techniques for process validation requirements for the FDA’s Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force.
Design Control Requirements: Integrating the Quality System Regulation and ISO 13485
Benefit from an intensive focus on design control requirements for the FDA’s Quality System Regulation, the international standard 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.
Design Control Requirements - Integrating the Quality System Regulation (July23)
July 17 to 19, 2023Register
Design Control Requirements - Integrating the Quality System Regulation (Nov23)
November 28 to 30, 2023Register
Purchasing Controls and Supply Chain Management
Learn from industry experts, who will help you understand effective implementation of supplier selection and controls. Each topic is presented from a practical perspective with links to the requirements of the Quality System Regulation, the ISO 13485 standard, risk management considerations, and pertinent Global Harmonization Task Force guidance.
Corrective and Preventive Action Requirements and Industry Practice
Learn the purpose of a corrective and preventive action (CAPA) system, its integration throughout a quality management system, appropriate data sources and how to manage them, relevant regulatory requirements, and much more.
Integrating Risk Management into the Product Lifecycle
Join us to develop an understanding of risk management concepts used throughout the quality system to successfully meet FDA, 14971, and 13485 requirements, as well as how to use risk management to make risk-based decisions for product realization from cradle to grave.