AAMI Course – Process Validation Requirements & Industry Practices – April 6-8, 2022
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 Course – Ethylene Oxide Sterilization for Medical Devices – March 22-25, 2022
This highly interactive 3.5-day, advanced course assumes that participants are experienced in working with an established ethylene oxide sterilization process but are now challenged with ensuring the continued effectiveness and assessing change for the product [...]
AAMI Training – Navigating 510k and De Novo Requirements – March 1-4, 2022
This 4-day course will navigate the 510(K) clearance process and De Novo classifications requests for United States (U.S.) and global Medical Device Manufacturers and regulatory affairs leaders to improve the ability to bring new and [...]
AAMI Course – Integrating Risk Management into the Product Life Cycle – February 9-11, 2022
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 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course [...]