Process Validation for Medical Devices

Course Description:

Warning Letters for process validation are becoming more common. In 2015, for example, almost 30% of the Warning Letters for QSR included process validation as one of the cited areas. These problems cover a range of issues such as lack of procedures, not following the procedures, documentation issues, statistical problems, and failure to manage the process input parameters.

Device manufacturers could avoid these troubles, and the Warning Letters, with a solid understanding of the principles of process validation. FDA does not have a guidance document on medical device process validation, so manufacturers are often unclear about how to proceed.

This course ensures you understand the regulatory requirements from both FDA QSR and ISO 13485:2003. To compensate for the lack of FDA guidance, the course draws on a variety of other sources including the GHTF guidance, FDA’s QSIT, FDA Warning Letters, and the guidance document for ISO 13485:2003.

This course helps design engineers, production engineers, quality engineers, and production people understand the regulatory requirements and the statistical methods needed to perform an effective process validation for medical devices. After validating the process, the manufacturer operates the process, collects information, and creates quality records.

Process validation is an integral part of the Quality Management System (QMS) and the Risk Management System (RMS) so the course covers those relationships. You will learn how to use process validation for ISO 14971:2007 risk reduction, apply corrective action properly in solving problems, and understand how process validation supports the production and process control requirements of QSR.

While not a regulatory requirement, the course uses the traditional Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) model. You will understand this common approach and the application of these traditional phases.

At its fundamental, however, process validation is applied statistics. You will learn the relationship between “validated with a high degree of assurance” and process capability indices. The course explains the use of design of experiments to define the input parameter space, an essential element of Operational Qualification.

This highly interactive course provides many examples and exercises that will help you explore the subject and solidify your learning.