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    Auditing the Risk Management File - By Dan O Leary

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    Website http://c2gowebinars.com/product/?topic=auditing-risk | Want to Edit it Edit Freely

    Category Medical Device

    Deadline: February 15, 2016 | Date: February 15, 2016

    Venue/Country: Online, U.S.A

    Updated: 2016-01-20 19:11:08 (GMT+9)

    Call For Papers - CFP

    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


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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