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, expertise, and quality solutions to blood banking, device manufacturing, and pharmaceutical businesses in the following areas:

  • Guidance for understanding and preparing 510(k) submissions to the FDA/CBER, and the reinstatement of U.S. licenses for blood establishments
  • Vendor audits for pharmaceutical manufacturers
  • Understanding FDA regulations, compliance requirements, and how to communicate effectively with the FDA
  • Quality assurance for manufacturers of blood and blood products, device manufacturers, and blood grouping reagent manufacturers
  • GMP/quality assurance programs

  • Prior Consulting Engagements Include:
    • Performed an evaluation of platelet validation strategies for a large blood collection agency
    • Worked with device manufacturers on 510k submissions that subsequently received clearance from FDA
    • Provided guidance to a device manufacturer following issuance of a Warning Letter. Performed a pre-FDA inspection audit. The FDA inspection result was no issuance of a 483
    • Performed audits of gamma irradiation firms that perform contract sterilization for device manufacturers
    • Provided guidance by review of records for sale of a product line of a coagulation product in an anti-trust case
    • Rated and classified Software Problem Reports and Enhancement Requests for a large blood collection agency. Trained staff to use the Health and Safety Protocol our team validated
    • Performed audits of blood and plasma establishments prior to FDA and CLIA inspections. Provided on-site guidance during FDA inspections as well as aiding in the creation of a response to the 483 following the inspection
    • Performed guidance during meetings with FDA following issuance of Warning Letters or following inspections

Find out more about audits.

Find out more about training programs.

| Home | About | FAQ | Contact |
| Consulting Services | Audits | Training |