AAMI – Quality System 21 CFR 820 and ANSI/AAMI/ISO 13485 – September 20-24, 2021
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 – Process Validation Requirements & Industry Practices – August 10-12, 2021
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 Training – Integrating Risk Management into the Product Lifecycle – June 28-30, 2021
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 [...]
AAMI Virtual Training – Process Validation Requirements & Industry Practices – April 14-16, 2021
Process Validation Requirements & Industry Practices is a 3-day, virtual training that will provide attendees with practical tools and techniques for process validation requirements to meet FDA’s Quality System Regulation, the ISO 13485:2016 Standard, and recognized Process [...]