is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Thursday, June 30th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Quality Management Systems (QMS) typically include provisions for the control of inspection, measuring, and test equipment. The QSR requirements are in 21 CFR §820.72, while the ISO 13485 requirements are in Clause 7.6.
Implementing these requirements requires attention to detail, accurate records, and effective systems. Manufacturers must understand the requirements so they can develop and implement effective processes and procedures. These procedures must include simple calibration stickers to aid in understanding accuracy and precision.
This audio conference explains the concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. The audio conference describes the concepts of accuracy and precision that define the measuring equipment’s requirements, and explains the meaning of traceability. With these concepts, the presentation moves to an analysis of FDA requirements and ISO 13485 requirements.
