Design Control and Product Validation

Engineers
Project leaders
Senior technicians
Scientists
Technical managers
Department heads

Quality assurance, compliance and regulatory personnel will also benefit because of their responsibility for implementation, validation and evaluation of design controls as part of the overall quality system. Sales and marketing personnel will learn their vital roles in providing input to the design process and requirements for design changes.

Description:
The course describes how to establish and implement a system for design controls for various classes of medical devices for both the U.S and Europe. It also provides guidance to assist manufacturers in knowing when controls are required. The underlying concepts will be explained in practical terms and exercises will be used to promote understanding. Sample procedures and forms will be provided in both hard copy and computer disc format.*

Emphasis will be on understanding the requirements and providing tools to assist in management of the design control process. The course will discuss each phase of the design process and explain the terms: design input, design output, design review, verification, validation, and design history file. Particular emphasis will be given to understanding the difference between design verification vs. design validation, and describing activities relative to validating a product design. Also discussed will be FDA's inspection strategy and how to manage a successful audit for design controls.

You will return to the workplace with new tools to apply an effective project management approach to your design control process which will ultimately reduce time to get to market, reduce development cost, and ensure regulatory compliance.