Training Course Syllabus:

Design Reviews and Design Controls to meet FDA Requirements Webinar

Description:

This webinar is intended to assist manufacturers in understanding the intent of the design controls regulations. Design controls are based upon quality assurance and engineering principles. Managers, engineers and regulatory staff must work together to make the process efficient and flawless. This webinar is conducted by the risk management consultant who turned around a Midwest company from going out of business to becoming the world leader in quality and reliability.

Why Should you Attend

Engineers think like engineers and marketing people “should” think like the customer. If you are designing a product to be used by nurses then get nurses on your design team. Simple things like naming conventions, color and where the button is located are big deals – they may not cause a recall but they will impact sales. Therefore, there is an urgent need for a paradigm shift in medical device safety to enhance quality, safety, and reliability through powerful applications of human factors engineering to optimize the relationship between users and medical devices, and monitor interactions among the devices.

The marketing department must act as a guide and lead the companies to bring awareness of variations in use/misuse and device interactions with other devices. This communication is vital to improving the design controls. Marketing has to participate in design reviews much more than once. Even sales and applications/sales training people should participate in this process.

Objectives of the Presentation:

• FDA requirements for design control


• Requirements for design and development planning


• Role of marketing and sales


• Role of engineering leaders


• Requirements for design input


• Requirements for design output


• Requirements for design review


• Heuristics for efficiency


• Requirements for design changes


• Requirements for design verification


• Requirements for design validation


• Requirements for design transfer


• Requirements for design history file

Seminar Summary:

Attend this webinar to learn the objectives of having design controls in medical device manufacturing, and elements of design controls. (see full course description)

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