This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International Organization for Standardization (ISO) standards development teams. Participants will learn how to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and ANSI/AAMI/ISO 13485:2016.
Program Objectives
Upon completing this program, participants will take home the knowledge to examine their quality management system to determine if it complies with both FDA Quality System requirements and 13485 requirements and recognize where improvements are needed. Participants will learn about the FDA inspectional approach and the Medical Device Single Audit Program. This course will empower the attendee with the knowledge to successfully host a FDA/MDSAP audit.
In addition, this course covers best practices, recognizing that different approaches may apply to various medical device classifications and to company size. This course is the one stop resource for learning industry best practices in implementing a QMS that meets global requirements.
To register and more info: https://us-tdm-tso-15eb63ff4c6-1626e-169df4b0a12.force.com/s/lt-event?id=a1Y2E000008Faw5