- Calibration programs
- Analytical method validation
- Equipment qualification
- Control of standards and reagents
- Documentation practices,
- Training programs, and
- Change control
Gretchen McAuliffe is one of the co-founders of Labtopia. As a Principal, Gretchen oversees operations
for Labtopia Staffing and is Senior Consultant for Labtopia Solutions, Labtopia Training and Labtopia
Informatix. Gretchen specializes in providing a wide range of quality support to ISO and GxP manufacturers,
laboratories, and distributors. As a QA professional, she is an expert in developing integrated systems
for regulated industries. She also has extensive experience in technical writing, business process mapping and
laboratory compliance. During her career, she has managed and conducted domestic and international
audits of manufacturers, distributors and laboratories.
Gretchen has a B.S. in Biology from the University of Houston and a M.S. in Biological Sciences from the
University of Houston-Clear Lake. She is an American Society for Quality (ASQ) Certified Quality Auditor
(CQA), Certified Biomedical Auditor (CBA) and a Certified HACCP Auditor (CHA). She is also one of the first
GMP professionals in the world to become a ASQ Certified Pharmaceutical GMP Professional (CPGP).
In addition, Gretchen is a is also a certified ISO 9001:2008 lead auditor and trained Administrator for
ThermoFisher Scientific’s SampleManager LIMS.
When she finds time to relax, Gretchen enjoys spending time with her husband Shannon and
their two daughters, Caitlin & Ciara. She enjoys traveling, a good book and a dinner with family and