AAMI Virtual Course – Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485 – April 18-22, 2022
This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International [...]
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 [...]