Effective (and FDA Compliant) Management Reviews
Date : 30 January 2019
Time : 02 : 00 PM EST
Duration : 60 MINUTES
Stevens, RAC has over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel. Finally, a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. As a consultant, he has presented over 20 webinars on FDA requirements.
Those in the medical device industry and combination product companies are aware that management reviews are required by FDA regulation, specifically in the Quality System Regulation, 21 CFR Part 820 and 21 CFR Part 4, The specific regulation is Part 820.20 (c). The regulation is not very specific on how to set up an effective management review procedure. Merely to hold a management review to please the regulators will in most cases be a waste of time. But by establishing effective management reviews, they will be a valuable tool to allow Senior Management to be more effective.
In this webinar, we will discuss all the essential elements for effective management review. We will discuss key requirements for the procedure, and how to schedule management reviews. We will also discuss how to measure the effectiveness of your management review program.
- What is the regulation?
- What does FDA expect?
- What are the key elements of a Management Review procedure?
- What data should be reviewed?
- How often should the review occur
- Who should attend the review?
- How do you measure the effectiveness of the review?
Course Level - Advanced / Intermediate
Who Should Attend
CEO’s, COO’s, General Managers, Senior Executives from key company functions, Regulatory Professionals, Quality, Assurance Professionals, industry consultants, and internal quality auditors.
Why Should Attend
So, we perform Management Reviews because FDA regulations require it? In fact, if you are performing management reviews only to satisfy FDA, you may be complying, but you are probably wasting your time. Effective management reviews should have tangible value to the senior executives performing the review.
In this webinar, we will review how to perform effective management reviews, that will assist in the effective management of the company. Effective Management Reviews will not only meet the regulatory requirement but also serve as a valuable tool for senior management too.
- Speaker: J. LAWRENCE STEVENS
- Webinar Code: LAWR-0002