Under 21 CFR Part 820.20, device manufacturers must establish management controls, including active participation from executive management, to ensure that an effective quality system has been established and maintained. Sounds simple, right?
Unfortunately, device firms have been running afoul of 820.20. Here’s what the FDA has found in recent warning letters:
This CD/Transcript of our Jan. 29, 2013 webinar will help you establish a quality policy and objectives. In addition, it will explain what data sets the FDA expects to support the quality objectives and demonstrate quality management system (QMS) effectiveness.
Noted QSR expert Dan O’Leary shares with you his proactive, proven plan for QSR 820.20 compliance. You will successfully understand:
The FDA’s focus on management — and their commitment to quality — is increasing every month. Act now.
Dan O’Leary has more than 30 years of experience in quality, operations and program management in regulated industries, including aviation, defense, medical devices and clinical labs. Mr. O’Leary is now president of Ombu Enterprises, LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a master’s degree in mathematics, is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt and is certified by APICS in resource management.
This CD/Transcript of the QSR’s 820.20 — Management Responsibility webinar is a must for professionals in device and diagnostics companies, including: