AAMI Virtual Course – Process Validation Requirements and Industry Practices – April 8-10, 2025
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 [...]
AAMI Virtual Event: Medical Device Software Validation – February 10 – 12, 2025
During this 3-day training, learn how to develop and validate medical device software in an ever-changing landscape of regulations and technology. This class will ground you in all the relevant regulations, standards and guidance and [...]
AAMI Virtual Event – Integrating Risk Management to the Product Life Cycle – January 27 – 31, 2025 – 1:00 pm to 5:00 pm
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 [...]
AAMI Virtual Event – Design Control Requirements – Integrating the Quality System Regulation – December 3 – 5, 2024
This intensive 3-day, virtual 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, [...]