April 21-23, 2010 – Process Validation for Medical Devices

Process Validation for Medical Devices

Who Should Attend

This course is targeted to professionals directly involved in meeting the FDA’s Quality System validation requirements such as those in regulatory affairs, quality assurance, process development or manufacturing. To maximize the peer learning opportunity, this course is recommended for those who may have a basic understanding of the Quality System Regulation (QSR), including direct work experience.

This course provides regulatory/quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA’s Quality System Regulation while offering information on how to implement an effective validation program.  The course is also intended for Medical Device professionals who are responsible for performing process validation studies and ensuring compliance with regulatory requirements for validation documentation.

Learning Objectives

The purpose of this course is to provide an introduction to the fundamentals of process validation, explaining how, when, where and why you should validate. Learn how to comply with FDA regulations for validation protocols and determine the format and function of such protocols. Addressed is how to maintain adequate validation documentation systems and perform equipment qualifications, process and software validations, and evaluate the need for re-validations.

Register here.