Effective (and FDA Compliant) Management Reviews

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 online training, we will review how to perform effective management reviews that will assist in the effective management of the company.

Why Should You Attend:

Effective Management Reviews will not only meet the regulatory requirement but also serve as valuable tool for senior management. Those in the medical device industry are aware that management reviews are required by FDA regulation, specifically in the Quality System Regulation, 21 CFR Part 820. 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.

Areas Covered in the Webinar:

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 effectives of the review?

Who Will Benefit:

• CEOs
• COOs
• General Managers
• Senior Executives from key company functions
• Regulatory Professionals
• Quality Assurance Professionals
• Industry Consultants
• Internal Quality Auditors