Quality Systems
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.
Featured Courses
Quality Systems and Risk Management
Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485
Our flagship course on quality systems
Quality Systems and Risk Management
Process Validation Requirements & Industry Practices
Practical tools and techniques for process validation requirements for FDA’s Quality System Regulation
Quality Systems and Risk Management
Validation of Analytical Procedures - Made Easy
Suppose you have a complex piece of laboratory equipment, or you are manufacturing a diagnostic medical device. A critical question is: “How do you know that you can trust measurements from those instruments?” This webinar will provide a working knowledge of Validation of Analytical Procedures. This very valuable statistical methodology is essential for laboratories and certain diagnostic medical devices.
Quality Systems and Risk Management
CAPA: Corrective and Preventive Action Requirements and Industry Practice
Year after year, one of the top reasons cited by the FDA in 483s is “lack of or inadequate procedures” for CAPA. This course will give you the knowledge you need to eliminate warnings due to CAPA-related issues.
Quality Systems and Risk Management
Purchasing Controls and Supply Chain Management
During this 2.5-day course, you’ll learn how to evaluate your organization’s compliance with FDA requirements for purchasing controls and acceptance activities, consider appropriate risk mitigation strategies for supplied products and services, and implement a life cycle management approach to your organization’s supply chain.
Quality Systems and Risk Management
Design Control Requirements - Integrating the Quality System Regulation
This highly interactive course engages the learner with in-depth discussion of industry best practices to learn how industry leaders address design control challenges.
Quality Systems and Risk Management
Integrating Risk Management into the Product Life Cycle
This course covers the use of risk management principles throughout the life cycle of the product.
Upcoming Events
Quality Systems
Design Control Requirements - Integrating the Quality System Regulation
May 1 to May 3, 2024
Regulatory
Key Updates: AAMI TIR48:2024 – QMS Recommendations for Combo Products
May 9 to May 9, 2024
Quality Systems
Corrective & Preventive Action Requirement & Industry Practice
Jun 6 to Jun 7, 2024
Quality Systems
Design Control Requirements - Integrating the Quality System Regulation
Jul 16 to Jul 18, 2024
Process Validation Requirements & Industry Practices
Aug 5 to Aug 7, 2024
Quality Systems
Quality System Regulation 21 CFR 820 & ANSI/AAMI/ISO 13485
Aug 19 to Aug 23, 2024
Sterilization
Ethylene Oxide Sterilization for Medical Devices
Aug 26 to Aug 29, 2024
