is being presented by Dan O'Leary, President, Ombu Enterprises and airs on Wednesday, May 19th, 2010. For more details or to register, please visit our site at www.fxconferences.com
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.
