FDA has been utilizing information based on inspections conducted by third parties and other regulators in different circumstances pursuant to MDUFMA 2002. This webinar is intended to help you get familiar with FDA's implementation of statutory requirements for setting risk-based FDA inspectional priorities. In particular, it deals with FDA's accepting voluntary ISO 13485 audit report submission requirements. This webinar is further intended to better understand FDA's medical device quality compliance program. As FDA is trying to leverage audits conducted by other regulators other than Health Canada and their accredited third parties in an effort to help the FDA set risk-based inspectional priorities, it is imperative we industry understand quality management system requirements implemented under ISO 13485 and ISO 13485 audit reports so that we can participate in the FDA's voluntary audit report submission program to save our time, efforts and various resources and to further assist the FDA's efforts setting the risk-based inspectional program.
This webinar will help you greatly increase your awareness and familiarity with the FDA's medical device quality compliance program, ISO 13485 requirements and FDA's voluntary ISO 13485 audit report submission program
At the end of this webinar, you will develop your insight on what is best for your business under limited resources and circumstances.
This webinar will help you greatly increase your awareness and familiarity with the FDA's medical device quality compliance program, ISO 13485 requirements and FDA's voluntary ISO 13485 audit report submission program
At the end of this webinar, you will develop your insight on what is best for your business under limited resources and circumstances.
