Process validation is an integral part of any manufacturing system, but is especially important for medical devices, where regulations (FDA QSR and ISO 13485) lay out the requirements manufacturers must follow. It applies when a company cannot, or does not, perform 100% verification of the process output – the product. Since you cannot verify all of the product produced by the process, you need another way to ensure the process produces good output – process validation. Regulators often expect process validation when a manufacturer uses sampling plans for verification.

This presentation helps attendees understand how to perform process validation. Our speaker defines the concepts, and divides process validation into three phases: Installation Qualification (IQ), Operational Qualification (OQ), and Production Qualification (PQ). The presentation explains how to develop protocols for each phase and write reports that document the results. In addition, the presentation explains the FDA QSR and ISO 13485 regulatory requirements for process validation, and uses FDA Warning Letters to point out some of the problems that can occur.

An effective process validation program can help reduce cost. Validated processes can operate at optimized points – points that eliminate or reduce the amount of nonconforming material. The presentation illustrates the concepts of controlling the process parameters and testing them at challenge points. This approach helps set the process parameters at optimum levels.

This audio conference covers:

• The regulatory requirements from the FDA
• The applicable clauses in ISO 13485
• The input parameters for a process and how to identify them
• Creating protocols and reports for IQ, OQ, and PQ
• FDA Warning Letters to illustrate some of the issues

About the speaker:

Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Who should attend?

• Quality Managers
• Quality Engineers
• Production Managers
• Production Supervisors
• Manufacturing Engineers
• Production Engineers
• Design Engineers