AAMI is a primary source of information and education for medical device professionals, from both industry and the FDA. Everything you need to know about the FDA Quality System regulation and ISO Quality System standards can be found in AAMI's in-depth training programs. Click here for a calendar of current listings.

Course Offerings

For additional information about AAMI's course offerings, please click on the links below.

• Quality System Requirements and Industry Practice
  4 day comprehensive course with optional ½ day exam covering all sections of the FDA Quality System regulation.
• Design Control Requirements and Industry Practice
  2½ day intensive course focusing on the how-to's of implementing a program that meets the FDA's design control requirements.
• Integrating Risk Management into the Quality System
  2½ day course designed for those who need a better understanding of risk management practices and how they are incorporated into the quality system. Those looking for guidance on regulatory requirements and ways that standards are related to risk management will also benefit from this program.
• Process Validation Requirements and Industry Practice
  2½ day intensive course provides the knowledge and skills needed to comply with FDA's process validation requirements.
• Software Validation Requirements and Industry Practice
  3 day intensive course supplies information and tools needed to comply with FDA's software validation requirements.
• Corrective and Preventive Action Requirements and Industry Practice
  2½ day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system and what is required for compliance with the FDA's Quality System regulation.
• Building a Quality Management System in a Regulated Environment: A 13485 Workshop
  2½ day workshop focuses on the synergy between the 13485 standard and the Quality System regulation, and how to maintain a quality management system that complies with both.

Webinars

AAMI is now offering webinars as a companion to its comprehensive and interactive training programs. To date, over 3,000 attendees have taken the opportunity to enhance their skills and knowledge through these cost-effective events.

A webinar is a learning event that you can attend from the comfort and convenience of your office. The savings are significant — completely eliminate travel time, hassle, and expense. Invite staff members to listen and participate all for one low fee. It's easy; you only need a telephone and access to the Internet.

For a list of AAMI's upcoming webinar offerings, as well as a listing of previous webinars available on CD, please click here.