Implementing an Internal Audit Program Compliant with ISO 13485 and 21 CFR Part 820
August 2, 2018 - Online Event ON CAWebinar Compliance
info@webinarcompliance.com
Phone:416-915-4438/ 58
This online seminar (webinar) is intended to help you get familiar with how to establish an internal audit program of the quality management systems (QMS) for medical device manufacturers in preparation for an FDA inspection under 21 CFR Part 820 or for those who are subject to ISO 13485.This webinar is also intended to greatly increase your awareness and familiarity with process-based approaches to internal auditing of quality management system requirements including FDA regulations affecting quality records and FDA’s policy on the reports required by the following regulations.– 21 CFR 820.20(c) Management review– 21 CFR 820.22 Quality audits, and supplier audit reports– 21 CFR 820.50(a) Evaluation of suppliers, contractors, and consultants