In addition, participants will work through a series of case studies that illustrate the various aspects of a software validation program. 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 requirements and paths to compliance. Additional course materials were developed by Alan Kusinitz, of SoftwareCPR in collaboration with experts from industry and members of AAMI's GMP course faculty, including FDA representatives. Course size is limited.
Early registration is encouraged.
No on-site registrations will be accepted. Founded in 1967, AAMI is a unique alliance of engineering, medical, nursing, industry, and government professionals united by the common goal of increasing the understanding and beneficial use of medical instrumentation. AAMI fulfills its mission by offering continuing education conferences, certifying specialists in health care technology, and publishing technical documents and periodicals. In addition to developing standards for medical devices, AAMI serves as Secretariat of several international committees, subcommittees, and working groups.