AAMI's 3 day course supplies attendees with information and tools needed to comply with the software validation requirements of the Quality System regulation, and provides guidance on how to implement effective validation programs. In addition, the course includes a discussion on AAMI TIR32 and how it relates to ANSI/AAMI/ISO 14971; an explanation on cybersecurity for networked medical devices containing Off-the-Shelf (OTS) software; an update on Part 11: tips on production and quality system software; and class exercises.

Objective
Upon completion of this course, participants will be able to apply the principles of software validation to their product, production process, and quality system. Participants also come away from the course with an awareness of relevant standards, FDA guidance documents, and other resources that will assist in defining acceptable compliance practices.

Format
This 3-day program provides intensive coverage of the elements of software validation. This highly interactive training format will include a variety of situational analyses that provide participants with the opportunity to apply new information to actual software validation scenarios. Industry "best practices" and FDA Warning Letters will be presented to demonstrate approaches to validation and paths to compliance. In addition, participants will work through workshops that illustrate the various aspects of a software validation program.

Who Should Attend?
Instruction is targeted to professionals directly involved in meeting FDA's Quality System requirements such as those in regulatory affairs, quality assurance and software product/process development. To maximize the peer learning opportunity, this course is recommended for those who already have a basic understanding of the design control requirements of the Quality System regulation or have experience with software engineering/software quality assurance.

Dates and Hotels

DATE LOCATION PHONE & RATES November 3-5, 2008 The Westin Casuarina Las Vegas Hotel Casino & Spa 160 East Flamingo Road Las Vegas, NV 89109 Web site 866-837-4215 / 702-836-5900 $189 single/double reservation ID: AAMI rate through October 3, 2008 NOTE: Reservation requests should be made as soon as possible, but no later than the rate through date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline. * Due to the number of events that AAMI is holding at the Westin Arlington Gateway in 2008, it is necessary to specify which course you are attending when making your room reservation.

Faculty
Course faculty are drawn from an experienced group of quality systems professionals. 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 to ensure a balanced presentation of the requirements and paths to compliance.

Course Materials
Participants will receive the standard

• ANSI/AAMI/IEC 62304:2006 Medical device software - Software life cycle processes; the technical information report
• AAMI TIR32:2004, Medical Device Software Risk Management
• AAMI TIR36:2007 - Validation of software for regulated processes
• Pertinent FDA documents; additional references; and a participant's guide for easy note-taking.

Registration Fees
Fee includes all course materials and continental breakfast, lunch, and refreshment breaks for three days.

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