This intensive 2½-day program covers the practical application of the design control requirements of the FDA's Quality System regulation to medical devices. Course content focuses on the how-to's of implementing a program that meets design control requirements while helping to ensure a fast and efficient flow of new products.

Objective
Upon completing this course, participants will be able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet both regulatory and business requirements.

Format
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.

Program At-A-Glance
The course consists of 2½ days of intensive coverage and practical application of the elements of design control.

Who Should Attend?
Instruction is targeted to professionals involved in meeting design control requirements such as those in regulatory affairs, quality assurance, design engineering, manufacturing, operations, and members of research and development or new product development teams. In 2006, FDA brought the course in-house to train Office of Compliance employees.

Faculty
Course faculty are drawn from an experienced group of quality system 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 design control requirements and paths to compliance.

Course Materials
Participants will receive The Quality System Compendium, 2ed. (the textbook from AAMI’s comprehensive course, Quality System Requirements and Industry Practice); pertinent FDA documents; additional references; and a participant’s guide for easy note-taking. Throughout the course, participants will refer to FDA design control guidance and related documents, such as the current design control inspectional strategy, the human factors guide, Do It By Design, and pertinent software and 510(k) guidance.

Development
Design Control Requirements and Industry Practice was developed at the request of participants in AAMI's comprehensive course, Quality System Requirements and Industry Practice. While the comprehensive course provides participants with a foundation in what the Quality System regulation requires, AAMI's Design Control course concentrates on the how-to's of meeting design control requirements.

Registration Fees
Fee includes course materials; continental breakfast and refreshment breaks for three days; and lunch for the first two days of the course.

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