In this Medical device recall training learn how to interface with FDA in regards to anticipated recalls, the communication, the response, how to prepare the public information.
Why Should You Attend:
In the recent past the US FDA has been criticized for its perceived failures in protecting the public from unsafe products. The widely publicized contaminated heparin use in medical products and drug failures such as Vioxxl have tarnished the image of FDA in its efforts to protect the public health. In response a new Commissioner was appointed with extensive experience in public health. She has rapidly changed FDA's response patterns to serious events.
The new FDA is working rapidly to improve its image with the public and with Congress in response to its perceived shortcomings over the past 20 years. This presentation will discuss how industry should interface with FDA in regard to anticipated recalls. Additionally we will discuss the potential response to the public in the event of a recall. The primary focus should be on providing a safe product and in the event of a failure to provide correct and complete information to protect the public health.
Areas Covered in the Seminar :

• Recent product recall failures.
• Analyzing product risks.
• CAPA prioritization.
• Communicating with FDA.
• Deciding on the response.
• Preparing the public information.
• Notifying the customers.

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Product overview (including all modules): AuditPro basic overview including all modules and most popular functions. Focused also on most popular AuditPro module Performance monitor
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AuditPro is a professional tool for Software Asset Management, which can be used easily and quickly to conduct a software audit of an entire company, to introduce necessary evidences and processes according latest SOM and ISO 19770 rules, and block the use of illegal software within any organization from 10 to thousands of PC.

With AuditPro it is even possible to make an effective use of all IT resources, make an optimal decision about investing into software, hardware, and effectively satisfy the demands of individual users. AuditPro is offering everything that IT specialists and managers need for their everyday use, and thanks to its unique concept based on latest Microsoft technologies and development tools, the implementation and integration of AuditPro with current systems even in large organization is days instead of months and the return from the AuditPro investment can be expected within weeks.

IT managers CIO`s and others, will gain fast and easy control over an entire computer and other asset, which comes under their management. To help them save time and money, AuditPro provides real-time enterprise solution, ready-to-use outputs, reports and analyzes the critical data of your company's computers, licenses, jobs, printers, toner cartridges and all other office investments to ensure that you get the most out of your budget. AuditPro reduces help desk costs by giving support staff instant information about individual PC configurations and software installation, enforces desktop standards by identifying and blocking applications that pose a security risk, upgrades network performance and improves user productivity.

A Czech product, AuditPro is becoming a well recognized international player. Both the Internet sales of the English version via the internet as well as through its own distribution network in Europe are growing dynamically. By the end of 2009, 700,000 licenses had already been sold in 12 countries and international sales represented a third of the entire sales, to which 6 language translations of the system contributed. We are no.1 SAM solution not only in the Czech and Slovak Republics but also in Poland, Russia and other countries over our distribution partners