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Auditing the Risk Management File - By Dan O Leary
Monday, 15th February 2016
01.00 PM
http://c2gowebinars.com/product/?topic=auditing-risk
Houston
Houston Texas 77042
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DESCRIPTION
Medical device manufacturers must implement risk management systems for their devices. This can be a complicated system requiring a lot of work and multiple resources. If it is not correct, the regulatory authorities may require corrective actions, a lot of extra documentation, and, in extreme cases, product recall. In addition, there is a strong link between risk management and product liability. In these cases, the device manufacturer is party to a lawsuit, and expert witnesses will review the risk management file. Incomplete or inadequate documentation could have a significant impact on the company?s reputation and financial situation.
A robust risk management system is part of the solution. However, it is difficult for people who work in the system to evaluate its adequacy; they may not always recognize any shortcomings or lapses. The solution is in the internal audit program. Linkage to the quality management system and its audit program requirements hold the solution. These systems require independence of the audit function. This is exactly the right approach ? a trained person performs an independent review.
The audit program can find the problems before the regulatory agencies and product liability attorneys. However, this means the audit program has this aim in mind. It must be more than just a checkbox; it must thoroughly examine the system and test it to make sure it works. This means planning the internal audit to verify conformance and raise issues to management. This webinar explains how!
Areas Covered In the Webinar:
The international risk management standard, ISO 14971:2007, and its implementation in the US, Canada, and the EU
Considerations for sampling plans selected by the audit team
An explanation of the enabling requirements and how to audit them
The issues the auditor should check to trace hazards through the risk management file
Checking the collection and evaluation of both production and post-production information
Reporting to management, especially management review
Who will benefit:
Medical device manufactures need to pay particular attention to the issues surrounding risk management and product liability. The risk management team should attend, including:
Audit Managers
Lead Auditors
Internal Quality Auditors
Design Engineering Managers
Design Control Team Members
Risk Management Team Members
Quality Assurance Managers
Complaint Managers
Corporate Counsel
Product Liability Attorneys
Webinar includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
A checklist to help plan the Risk Management File Audit
Certificate of Attendance
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