Design Control Requirements and Industry Practice

Industry field:

Medical Device

Combination products (drug/device, biologic/device or drug/device/biologic)

Course description:

This intensive 2½-day course covers the practical application of the design control requirements of the Quality System regulation to medical devices. The program has been revised to include more hands-on exercises, more "how-to" information on implementation of design control requirements, increased focus on life cycle aspects of risk management and human factors, and more up-to-date industry examples.

Learning objectives:

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

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.

Course facts

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