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June 2010

Marla A. Phillips

Six New FDA Enforcement Policies: How They Impact You

Marla A. Phillips
Med-XU, Xavier University

On August 6, 2009, FDA Commissioner Dr. Margaret Hamburg publicly announced the FDA's new enforcement strategy. This strategy involves six new policies that went into effect on September 15, 2009. What are the policies and what do they mean to you? The best line of defense is to have excellent quality oversight now to ensure that the systems in place are compliant, functional, and effective. Then your firm won't have to worry about getting a warning letter in the first place. Easier said than done but more critical now than ever.

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Robin Nozick

Quality Risk Management Approach to ISBT Validation

Robin Nozick
MT(ASCP), American Red Cross Headquarters, ISBT Technology Lead

According to the ISBT-Guidelines For Validation of Automated Systems in Blood Establishments (Guidelines) the blood bank is responsible for the regulatory compliance of the automated/computerized systems used at the Facility and MUST have a Quality Management System (QMS). Blood Banking organizations around the world support these guidelines, which prescribe that full validation of the computerized system be required for systems critical to product and quality (information management, storage, tools for operational decision-making and control).

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Michael J. Gregor

Computer System Validation: FDA Inspections

Michael J. Gregor
President, Compliance Gurus, Inc.

Is your organization ready for an inspection of your Computer System Validation program? In this article, I will offer some key tips on how to prepare for an inspection of your computer system validation (CSV) program. Often times, the FDA comes to inspect your facility for reasons other than your CSV program. However, because so many of our business processes are governed by electronic systems, the topic of Computer System Validation inevitably comes up during the course of an inspection. As a result of an increase in federal investigators, investigators are able to inspect more facilities and dig deeper into areas such as Computer System Validation.

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Did you know that according to a recent article, "Why Aren't Hospitals More Concerned About Blood Safety?" that even blood without disease or viruses can still be harmful to blood transfusion patients? Find out more about the dangers of blood transfusion and what many blood bank organizations, private donors and government are doing to reduce both major and minor transfusion symptoms.
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