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QualityHub is proud to bring such a diverse team of consultants to our clients. With consultants averaging over 25 years experience in the FDA regulated environment, we are often asked to share our thoughts and experience with industry publications. Below is a list of recent and past articles written by our associates.

Published Articles

• Originally Published in MDDI Magazine, October 2006:
  Scrutinizing the Scrutinizers (an architect of FDA's QSIT inspection protocol discusses the improvements it has brought and what he would change about it.)
• FDANews, Device & Diagnostics Letter, Vol. 30, No. 49 Dec. 15, 2003:
  Quality Systems, Training must be included in documentation system
• FDLI Update Magazine, September/October 2003:
  The Benefits of Incorporating Quality Systems in the Drug GMP Regulation
• ASQ Biofeedback, Volume 30, No. 1, Winter 2001:
  Cover Story, (Starts on Page 7)
• Medical Device & Diagnostic Industry (MDDI) Magazine, October 2000:
  Is the U.S. Meeting the Global Harmonization Guideline for Auditing Quality Systems?
• Medical Device & Diagnostic Industry (MDDI) Magazine, January 2000:
  Validation of FDA's New Quality System Inspection Technique
• Medical Device & Diagnostic Industry (MDDI) Magazine, October 1999:
  QSIT: The New Quality System Inspection Technique
• Medical Device & Diagnostic Industry (MDDI) Magazine, June 1999:
  Quality and Productivity: Then and Now (written by Associate Chuck Truby)
• Quoted by "Understanding Government"
  The FDA Meets the 21st Century, (8 paragraphs from the end)

Published Guidelines

• QSIT (Quality Systems Inspection Technique) FDA Guidebook:
  QSIT Guide - Inspections of Quality Systems (pdf)
• AdvaMed, FDA Inspections Under QSIT:
  Points to Consider When Preparing for an FDA Inspection Under the QSIT Design Controls Subsystem
• AdvaMed, FDA Inspections Under QSIT:
  Points to Consider When Preparing for the FDA Inspection Under the QSIT Corrective and Preventive Actions Subsystem
• AdvaMed, FDA Inspections Under QSIT:
  Points to Consider When Preparing for the FDA Inspection Under the QSIT Management Controls Subsystem