AAMI Virtual Event – Design Control Requirements – Integrating the Quality System Regulation – September 12-14, 2023
This intensive 3 – day 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 [...]
AAMI Event – Process Validation Requirements & Industry Practices – August 7-9, 2023
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 Course – Design Control Requirements – Integrating the Quality System Regulation – July 17-19, 2023
This intensive 3 – day 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 [...]
AAMI Online Course: Risk-Based Computer Software Assurance Approach for PPQS – July 11th and July 13th from 1:00 pm to 3:00 pm EST
This course is designed for software developers, quality engineers, auditors, process engineers, manufacturing engineers, quality assurance and regulatory compliance personnel, or others involved in the use of Production Process and Quality System Software and responsible [...]