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Certifying Your Blood Establishment

Offering consulting services, audits, and educational programs for companies and blood establishments seeking FDA compliance and regulatory guidance, and who wish to leverage their capabilities to the fullest extent.

With over 30 years extensive experience in the blood banking industry, MaryAnn Tourault has emerged as a leading independent consultant to blood and plasma establishments and pharmaceutical manufacturers in the areas of regulatory guidance and compliance.

With an American and international client base, Ms. Tourault has consulted on regulatory and quality assurance matters for manufacturers of blood and blood products, device manufacturers, and blood grouping reagent manufacturers. Additionally, she has performed vendor audits for pharmaceuticals in order to ensure compliance with FDA guidelines.

Why Consult With Mary Ann Tourault?

Bringing the business sense, technical expertise, practical experience to help her clients, the benefits of engaging Ms. Tourault are many:

Over thirty years blood banking experience:

  • U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Compliance and blood program divisions
  • National Institutes of Health Clinical Center Blood Bank
  • Private hospital transfusion services
Extensive experience in conduct of blood and plasma establishments and in training programs related to inspections:

  • Both oral and written guidance for FDA field investigators
  • National training programs for FDA investigators, supervisors, and compliance officers in laboratory quality assurance
  • Production of training videos used for good manufacturing practice (GMP) training programs for the blood community
  • More than thirty workshops for the American Society of Clinical Pathologists, American Association of Blood Banks, the American Red Cross, the American Blood Resources Association and other members of the blood community
Consulted in the regulatory and quality assurance areas for manufacturers of blood and blood products, device manufacturers, and blood grouping reagent manufacturers.

Performed vendor audits for pharmaceutical manufacturers.

In matters concerning very specific FDA regulations, Ms. Tourault has assisted many American and European clients in understanding FDA regulations and compliance requirements, and how to communicate effectively with the FDA. Her involvement as a consultant has proved invaluable to many organizations and manufacturers, for example, she has facilitated FDA interaction for many clients, including the processing of 510(k) submissions with CBER and the reinstatement of U.S. licenses.

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  Who Checks the Checker
by Mary Ann Tourault

At the conclusion of an FDA inspection, many times the Investigator issues a FDA-483 to list the observations noted during the inspection. There is no guarantee that an item listed is a true deficiency from regulations or a deviation in Current Good Manufacturing Practices (cGMPs). The observations noted are one person's opinion, which should be based on documented evidence.




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...

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:
click here...


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