Comprehensive Overview of FDA Regulatory Compliance for Medical Devices
June 19 - 20, 2012 - King of Prussia PA US
Center for Professional Innovation and Education, Inc.
Phone: (610) 688-1708
This two-day course has been developed for those who are involved with ensuring regulatory compliance for medical devices. The course is primarily geared towards those who are new to industry or require a basic understanding of medical device regulatory compliance issues, but is valuable to anyone looking for a refresher or a means to stay current with regulatory agency thinking. The course content is designed to provide an in-depth understanding of the paths to obtaining agency approval; how the FDA performs inspections; the type of controls, systems and documentation they expect to see in place; and the variety of outcomes from each inspection. The course also covers the remedies available to show inspectors that manufacturing processes are in full compliance with quality system requirements.