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.

Articles written on current issues for industry publications:

• What is the significance of FDA Form-483?
• Response to the FDA 483
• Who Checks the Checker?

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