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AUDITS
Audits for Blood Bank Establishments & Pharmaceutical Manufacturers

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:
  • Regulatory analysis of establishment
  • Review of corrective actions
  • Prepare management and staff for FDA inspections
  • On-site assistance during FDA inspections
  • Supplier/Vendor audits
  • GMP audits for blood establishments:
    — Blood centers
    — Plasma centers
  • Vendor audits for manufacturers:
    — Pharmaceutical manufacturers
    — Manufacturers of blood grouping reagents
    — Manufacturers of medical devices
  • Audits for testing laboratories

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 MARY ANN TOURAULT
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.
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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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