Rook Quality Systems webinar on mastering your next audit. Discover expert strategies and best practices to ensure compliance, streamline processes, and confidently navigate audits with success. Don't miss this opportunity to elevate your quality management approach and achieve excellence in regulatory assessments.
During our 60-minute discussion, presenter Kyle Rose of Rook Quality Systems covers the following topics:
00:00 - Intro About the Speaker; Kyle Rose Rook Quality Systems Reshoring Institute
01:51 - About Rook Quality Systems (RQS)
03:42 - FDA Inspections
04:15 - Understanding what happens during an FDA Medical Device QMS Inspection
09:50 - FDA QSIT Methodology
12:17 - What FDA Inspectors look for
25:34 - What happens at the conclusion of an FDA Inspection/Audit
28:54 - ISO Audits
29:31 - What is an ISO audit?
31:35 - Who is subject to ISO audits?
35:01 - Different types of ISO audits
43:20 - How to prepare for an ISO audit
47:37 - Conducting an ISO audit
48:44 - What happens after an ISO audit?
50:55 - FAQs and Closing