This webinar provides a basic understanding of the records required to fulfill requirements of both US FDA 21CFR 820 and ISO 13485:2016 for establishment and maintenance of a Device Master Record. It will further discuss the responsibilities of various development team members such as R&D/engineering, operations, quality assurance, project management and executive management.
Why Should You Attend:
This webinar will cover basic requirements for the content of a Device Master Record for compliance to 21CFR 820 and ISO 13485:2016 and will review potential differences in the requirements between the two regulatory standards. It will further discuss the difference between a Device Master Record (DMR) and a Device History Record (DHR) including the differences, if any, between a device Batch Record and a Device History Record?
Attendees will learn how a DMR can assist with compilation and quality assurance review of a DHR – especially for device products with multiple components. It will further help them understand what document control means for DMR documents (records).
Who Will Benefit:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Mary H Nunnally, PhD, is an experienced Quality and Operations Executive (20+ years) within the medical device, biomedical research product, veterinary medicine and pharmaceutical industries. She has an extensive hands-on experience in the establishment and maintenance of US FDA 21CFR 820, ISO 13485 and ISO 9001certified Quality Systems, including implementation of all systems required for compliance with US, CMDR, and EU regulatory statutes.