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U.S. Food and Drug Administration
Blood

The FDA is responsible for ensuring the safety of our nation's blood supply. The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves. CBER also regulates related products such as cell separation devices, blood collection containers and HIV screening tests that are used to prepare blood products or to ensure the safety of the blood supply. CBER develops and enforces quality standards, inspects blood establishments and monitors reports of errors, accidents and adverse clinical events. CBER works closely with other parts of the Public Health Service (PHS) to identify and respond to potential threats to blood safety, to develop safety and technical standards, to monitor blood supplies and to help industry promote an adequate supply of blood and blood products. While a blood supply with zero risk of transmitting infectious disease may not be possible, the blood supply is safer than it has ever been.

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ASK THE EXPERT
 

1) How do I respond to FDA Form 483?
What is the significance of FDA Form-483?
Response to the FDA 483
Who Checks the Checker?
2) How do I respond to a warning letter?
3) How do I respond to a license suspension?
4) How do I perform a 510(k) submission?

ANSWER: ASK MARY ANN TOURAULT
PAPER ICON AUDITS:

Timely and relevant examination of Good Manufacturing Practices (GMP) is critical to blood bank establishments and pharmaceutical manufacturers. Ms. Tourault's broad expertise allows her to perform a full lifecycle of audits, allowing clients to concentrate on their core business.
Audits can be performed in the following areas: click here...


PAPER ICON BLOOD BANK CERTIFICATION

As a premier provider of consulting services in the U.S. and Europe, Ms. Tourault consistently delivers the greatest depth of capabilities, and quality solutions to blood banking, device manufacturing, and pharmaceutical businesses in the following areas:
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