Robert Packard Presents a free webinar for BoneZone sponsored by Medical Device Academy.
Robert discusses common management review mistakes and guidance on how to avoid preventable nonconformities and 483 Letters for your management review process for both your ISO Audit, and FDA Inspection.
The advice in this management review webinar is intended to keep senior management engaged during management review meetings. I’ve been doing management reviews this way he has since 2003. Your meetings will be shorter and more effective.
In 2012, the FDA Issued 219 findings against management responsibilities and the management review process. The management review meeting minutes may be officially “out of reach,” but there are FDA inspectors that will ask for this document anyway. Do you really want to be perceived as hiding something?
Does the CEO and CFO of your company complain about the length of management review meetings?
Did you receive a nonconformity during your last audit, because you forgot to include one of these required items?
Eight Inputs
Three Outputs
Review of the Quality Policy
Review of the Quality Objectives
Review of the QMS effectiveness
Robert has performed hundreds of quality system audits. Each of those audits involved reviewing management reviews. There are dozens of ways to conduct a management review, but only a few methods are simple, efficient and foolproof.
What you will learn from the Management Review Webinar:
Management review requirements
Documentation of meeting minutes
Delegating meeting preparation
Minimizing boredom
Improving the bottom line
Who should attend the Management Review Webinar?
OEMs and contract manufacturers both need to conduct management reviews to ensure the effectiveness of the quality management system. The ISO 13485 standard and 21 CFR 820 both require that your company conduct a management review. Therefore, everyone in top management at a medical device company should watch this management review webinar. If you are the management representative, you can’t afford to miss this opportunity. If you hate management reviews, you will like this method better.
For our paid trainings and webinars please visit us at
medicaldeviceac....
Негізгі бет SYS-003 Management Review Procedure for ISO 13485:2016 updated for 2020
Пікірлер