Design Control Course Headlines Fall Programs
Ten years after launching its popular Design Control Requirements and Industry Practice course, AAMI has revamped the course to make it a more hands-on experience for participants.
The revised course, which headlines a busy calendar of AAMI educational programs this fall, “has also been updated to include the latest in industry best practices,” says Tammy Pelnik, who developed the course curriculum and has taught the course for eight years. “We have been canvassing the industry for their input on best practices, and we will explore with participants the current industry focus on integrating design control with human factors and risk management.”
FDA asserts that the safety and effectiveness of a device are established during the design phase. Thus, to ensure that good quality assurance practices are used during the design of medical devices, the agency incorporates a design control component into its Quality System Regulation.
“If a device manufacturer is not compliant with FDA’s design control requirements, they will have difficulty gaining approval for their devices,” says Pelnik. “And they’ll have problems when their facility is inspected by FDA.”
Device recalls are often a result of inadequate design control as well.
The revamped design control course will provide more hands-on exercises than ever before to help participants understand what it takes to apply the regulations and be fully compliant. The experienced faculty for each course offering includes instructors with industry experience and a representative from FDA. The Design Control Requirements and Industry Practice course will be held Dec. 1–3 in San Diego, CA.
Pelnik notes that she and her co-instructors continue to talk with industry professionals about design control best practices, and she encourages individuals with ideas to contact her at pelnik@stvrain.com. “We are still accepting feedback from industry on examples of design control procedures and forms, strategies, etc., to incorporate into the course.”
This fall, AAMI will also be holding an education course in Europe, as AAMI brings its Quality System Requirements and Industry Practice to London, Oct. 20–24. This intensive four-day program provides quality system professionals with the basic knowledge and skills needed to develop a quality system program that conforms to FDA’s Quality System regulation.
Upon completing the program, participants should be able to examine their own quality systems to determine whether they comply with FDA requirements, and to recognize where improvements are needed. In addition, the course covers acceptable compliance practices, recognizing that different approaches may apply to various medical device classifications and to company size. An optional 2.5-hour exam, immediately following the course, is administered to test mastery of the course materials and ability to interpret the regulation correctly.
In addition to the London program, the Quality System course will be held in San Diego, CA, Sept. 22–26, and in Arlington, VA, Dec. 8–12.
Click here for a complete look at AAMI’s remaining 2008 educational calendar. For more information or to register for a course,visit www.aami.org/meetings. To register for a webinar visit www.aami.org/meetings/webinars.
AAMI News: September 2008, Vol. 43, No. 8