This course offers FDA and industry the unique opportunity to participate in a shared learning experience. Participants have cited FDA participation and the opportunity to hear FDA expectations and perspectives, firsthand, as one of the most valuable aspects of the learning experience. Examples of design control tools, templates and practices, in use by AAMI member companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements and evaluate the various methods of managing a design control program. During this highly interactive learning experience, participants are given ample opportunity to discuss the different approaches that can be taken depending on company size or device classification.
Instruction is targeted to professionals directly involved in meeting design control requirements.
Past participants include industry experts and staff from the FDA's CDRH and field investigations. All course faculty have completed an instructor training program to ensure consistency and quality from session to session. The mix of industry leaders, consultants, and FDA personnel helps ensure a balanced presentation of the design control requirements and paths to compliance. While the comprehensive course provides participants with a foundation in what the Quality System requires, AAMI's design control course concentrates on the how-to's of meeting design control requirements. 260 to order with credit card.