COURSE DESCRIPTION

OVERVIEW

Since 1990, FDA has required medical device manufacturers to follow design controls. Outside the US, the Medical Devices Directive (MDD) lists similar requirements as part of their quality system regulations.  Although medical device manufacturers must have design control systems in place, they are not always effective.

Inadequate design control procedures are commonly cited in warning letters, CAPA’s and product recalls.  An average of 44% of quality problems resulting in recall actions are attributed to deficiencies that may have been prevented by adequate design controls, and around 30% of warning letters listed inadequate design controls procedures in recent years. Clearly, having design controls in place is not enough.

In addition, because design controls must apply to a wide variety of devices, they do not specify what manufacturers must do to meet these requirements.  Instead, they establish a framework that provides manufacturers with the flexibility needed to develop design controls that both comply with the regulation and are most appropriate for their own design and development processes.

LEARNING OBJECTIVES

This 90-minute course will allow you to:

1. Learn how design controls apply to both design and manufacturing
2. Appreciate design verification and validation and the importance of each
3. Hear how to properly modify a design or a process without causing problems later
4. Determine how to properly conduct a design review
5. Learn to integrate design control, risk management, and CAPA into an overall system
6. Identify the keys to success in design transfer to manufacturing
7. Understand what FDA looks for in a design control system

Learn to think beyond what the regulation says and apply best practices to avoid the most common design control problems.